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The Immediate Effects of Implantable Cardioverter Defibrillator Shocks on Patients and Their Spouses

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The Immediate Effects of Implantable Cardioverter Defibrillator Shocks on Patients and Their Spouses
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WALKER, ROBYN LYNN ( Author, Primary )
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2008

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Anxiety ( jstor )
Death ( jstor )
Defibrillators ( jstor )
Fear ( jstor )
International Statistical Classification of Diseases ( jstor )
Psychological assessment ( jstor )
Psychosociology ( jstor )
Spouses ( jstor )
Statistical discrepancies ( jstor )
Women ( jstor )

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University of Florida
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University of Florida
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Copyright Robyn Lynn Walker. Permission granted to the University of Florida to digitize, archive and distribute this item for non-profit research and educational purposes. Any reuse of this item in excess of fair use or other copyright exemptions requires permission of the copyright holder.
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12/31/2009
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71332210 ( OCLC )

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THE IMMEDIATE EFFECTS OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SHOCKS ON PATIENTS AND THEIR SPOUSES By ROBYN LYNN WALKER A DISSERTATION PRESENTED TO THE GRADUATE SCHOOL OF THE UNIVERSITY OF FLOR IDA IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF DOCTOR OF PHILOSOPHY UNIVERSITY OF FLORIDA 2004

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Copyright 2004 by Robyn Lynn Walker

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ACKNOWLEDGMENTS This dissertation is dedicated to everyone who helped me through graduate school and life thus far. First, I would like to thank my parents, Craig and Cathie Wallace; and my brother, Tye. Without them I would not be where I am today nor who I am today. I also would like to thank my grandmother, Margery Harp, for her love and support; and for the strength and courage she has shown throughout her life. This dissertation is also dedicated in the memory of my grandparents, Clifford and Miriam Wallace and Robert Harp, who still live within each person who loves them. I would like to acknowledge the Weisenfeld family, the Wallace family, Dave Harp, and Dave Wallace for all of their guidance, love, and support throughout my life. I would also like to thank the Walker family for their love and understanding; and for the frequent use of their extra bedroom. Finally, I especially owe my most sincere thanks to my husband, Stephen Walker. He has been by my side for most of my life, in both good times and bad, and will always be by my side. He is my solid ground in a world full of quicksand. My good friends Sara, Jessi, Marissa, and Susan also deserve special mention. If they were not there for me, I would not have made it this far in life, at least not in one piece. Their support and kindness helped to make me a better person and helped me to understand what true friendship means. Many people helped me design, implement, and complete this research project. Jason Burns helped me understand that laughter is always the best medicine. I thank him for his support and advice throughout graduate school. Rebecca Sotile and Eva Serber iii

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offered constant honesty, support, and guidance. They made me realize how much great people can accomplish; and that good support can get you through almost anything in life, including graduate school. Emily Kuhl deserves special mention for her dedication to this project as if it were her own. I truly believe that this project could not have been completed without her assistance. I also would like to thank cardiologists Dr. Jamie Conti and Dr. Anne Curtis for their support of this project and for their continuous collaboration. Finally, I greatly appreciate the work of my supervisory committee members, Dr. James Rodrigue, Dr. Garrett Evans, and Dr. James Jessup. I am honored to have each as a member of my committee. I thank them for all of their assistance and insight. Mostly, I thank Dr. Samuel F. Sears for his ongoing support, mentoring, and guidance for me as an individual and for this project. He helped me to constantly challenge myself, both personally and professionally. iv

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TABLE OF CONTENTS Page ACKNOWLEDGMENTS.................................................................................................iii LIST OF TABLES............................................................................................................vii ABSTRACT.....................................................................................................................viii CHAPTER 1 INTRODUCTION........................................................................................................1 2 LITERATURE REVIEW.............................................................................................4 Death Anxiety...............................................................................................................4 Introduction and Definition...................................................................................4 Behavioral Manifestations.....................................................................................6 Shock Anxiety............................................................................................................10 General Anxiety..........................................................................................................12 Avoidance Behaviors..................................................................................................12 Marital Satisfaction.....................................................................................................15 Internet-Based Assessment.........................................................................................16 Aims and Study Justification......................................................................................17 Hypotheses..................................................................................................................19 Question 1............................................................................................................19 Question 2............................................................................................................20 Question 3............................................................................................................20 Question 4............................................................................................................21 Question 5............................................................................................................22 3 METHOD...................................................................................................................23 Sample........................................................................................................................23 Procedure....................................................................................................................27 Measures.....................................................................................................................29 Death Anxiety......................................................................................................29 Shock Anxiety.....................................................................................................29 General Anxiety...................................................................................................30 Avoidance Behaviors...........................................................................................30 Marital Functioning.............................................................................................30 v

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4 RESULTS...................................................................................................................32 Sample Descriptives...................................................................................................32 Hypothesized Analyses...............................................................................................35 Hypothesis 1........................................................................................................36 Hypothesis 2........................................................................................................37 Hypothesis 3........................................................................................................38 Hypothesis 4........................................................................................................39 Hypothesis 5........................................................................................................40 Post-Hoc Analyses......................................................................................................40 Shock Anxiety Survey.........................................................................................41 Gender Differences..............................................................................................43 Death Anxiety and Shock Anxiety Relationship.................................................47 5 DISCUSSION.............................................................................................................50 Psychosocial Frequencies...........................................................................................50 Hypothesized Analyses...............................................................................................53 Participant Group Differences.............................................................................53 Avoidance Behaviors...........................................................................................54 Effects of Shocks.................................................................................................55 Method of Evaluation Differences......................................................................56 Changes over Time..............................................................................................57 Shock Anxiety Survey.........................................................................................58 Gender Differences..............................................................................................58 Death Anxiety and Shock Anxiety Relationship.................................................60 Limitations..................................................................................................................60 Conclusions.................................................................................................................62 APPENDIX A PATIENT QUESTIONNAIRES................................................................................64 B SPOUSE QUESTIONNAIRES..................................................................................70 LIST OF REFERENCES...................................................................................................76 BIOGRAPHICAL SKETCH.............................................................................................82 vi

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LIST OF TABLES Table Page 2-1. Hypothesis 1...............................................................................................................20 2-2. Hypothesis 2...............................................................................................................20 2-3. Hypothesis 3...............................................................................................................21 2-4. Hypothesis 4...............................................................................................................21 2-5. Hypothesis 5...............................................................................................................22 3-6. Patient and spouse demographic characteristics.........................................................25 3-7. Patient medical variables............................................................................................26 4-8. Baseline patient psychosocial measure means...........................................................34 4-9. Baseline spouse psychosocial measure means...........................................................34 4-10. Follow-up patient psychosocial measure means......................................................34 4-11. Follow-up spouse psychosocial measure means......................................................35 4-12. SAS patient version correlations..............................................................................44 4-13. SAS spouse version correlations..............................................................................45 4-14. Psychosocial means for female ICD patients...........................................................47 4-15. Psychosocial means for male ICD patients..............................................................47 A-1. Patient questionnaires...............................................................................................64 B-1. Spouse questionnaires...............................................................................................70 vii

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Abstract of Dissertation Presented to the Graduate School of the University of Florida in Partial Fulfillment of the Requirements for the Degree of Doctor of Philosophy THE IMMEDIATE EFFECTS OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SHOCKS ON PATIENTS AND THEIR SPOUSES By Robyn Lynn Walker December 2004 Chair: Samuel F. Sears Major Department: Clinical and Health Psychology The purpose of this project was to evaluate the effects of Implantable Cardioverter Defibrillator (ICD) shocks on shock anxiety and death anxiety; and to evaluate the resultant effects on patient and spouse psychological, behavioral, and marital functioning. The original methodology planned to follow ICD patients for 6 months to evaluate the immediate effects of shocks. However, no ICD patients were shocked within this 6-month period. Therefore, only data from the baseline assessment were utilized in the analyses. Forty ICD patients and 22 spouses completed questionnaires evaluating shock anxiety, death anxiety, general anxiety, avoidance behaviors and marital satisfaction. Analyses determined that patients and spouses reported similar levels of shock anxiety, death anxiety, general anxiety, and martial satisfaction. Shock anxiety was determined to be a significant predictor of avoidance behaviors in ICD patients, above and beyond shocks. ICD shocks were found to be associated with increased levels of shock anxiety (and to lesser extent with death anxiety) in patients and spouses. Analyses comparing viii

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Internet-based evaluations and paper-based evaluations determined that there are no significant differences in the amount or type of psychosocial information revealed by ICD patients and their spouses. Finally, because no patients were shocked within the 6-month interim follow-up period; an analysis was conducted that showed no significant differences between baseline and follow-up on any of the psychosocial measures. Post-hoc analyses were conducted to further investigate interesting findings that surfaced during the hypothesized analyses. Female ICD patients reported increased risk of death anxiety and shock anxiety; and received more shocks, despite equivalent indices of medical severity. The validity and reliability of the Shock Anxiety Scale was initially evaluated in this study and was found to be an accurate and reliable measure of feelings of anxiety related to ICD shocks in patients and spouses. Finally, death anxiety and shock anxiety were found to be associated with each other, with female gender, and with previous shocks. Shock anxiety and death anxiety appear to be significant concerns for ICD patients (especially females who have received shocks) and their spouses; and should be the focus of future research and clinical interventions. ix

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CHAPTER 1 INTRODUCTION Each year in the United States, approximately 400,000 people experience sudden cardiac arrest (Jones, 1994). Sudden cardiac death is caused by life-threatening ventricular arrhythmias, such as ventricular tachycardia (VT) or ventricular fibrillation (VF), which can result in death if treatment is not immediately available (e.g., within 10 minutes) (American Heart Association, 1997). The implantable cardioverter defibrillator (ICD) is the treatment of choice for patients diagnosed with life-threatening ventricular tachycardia and/or ventricular fibrillation and is implanted in 60,000 U.S. residents annually. The ICD is a pacemaker-size, indwelling device that detects and attempts to correct ventricular arrhythmias by means of pacing, cardioversion, and defibrillation via electric pacing and shock. The ICD’s corrective actions for irregular heartbeats (e.g., shock therapy and cardiac pacing) are usually programmed to be incremental in intensity and are automatic. Two initial clinical trials designed to test the efficacy of ICDs in comparison to the anti-arrhythmic medications were terminated early due to decreases in the all-cause mortality rates in patients with an ICD as compared to anti-arrhythmic medicine. The first of these clinical trials, the Multi-center Automatic Defibrillator Implantation Trial, (MADIT; Moss, Hall, Cannom, Daubert, Higgins, Klein, Levine, Saksena, Waldo, Wilber, Brown, & Moonseong, 1996), assessed the efficacy of the ICD and resulted in a 54% decrease in mortality over a five-year period in patients treated with the ICD as compared to anti-arrhythmic medicine (Moss et al., 1996). The second trial investigating 1

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2 the effectiveness of the ICD versus anti-arrhythmic medications was the Anti-arrhythmics Versus Implantable Defibrillators (AVID) trial, which demonstrated a 38% reduction in mortality over one year for patients with an ICD (AVID Investigators, 1997). Additionally, recent investigations suggested that the ICD may help save lives in increasingly larger and more diverse groups of patients with cardiac disease, which have resulted in the ICD becoming increasingly more prominent (MUSTT; Multicenter Un-Sustained Tachyarrhythmia Trial; Buxton, Lee, & Fisher, 1999; MADIT II; Moss, Zareba, Hall, Klein, Wilber, Cannom, Daubert, Higgins, Brown, & Andrews, 2002). Due to the establishment of reduced mortality in these trials and the increasing numbers of persons receiving these devices, there has been more consideration and scrutiny of the psychosocial impact of the ICD and its therapeutic shocks. Consistent with the general cardiac literature (Rozanski, Blumenthal, & Kaplan, 1999), significant rates of psychological distress occur in ICD patients with as many as 38% experiencing either general or ICD-specific anxiety (Sears & Conti, 2002; Carney, Freedland, Sheline, & Weiss, 1997). The experience of sudden cardiac arrest and the possibility of unexpected life-threatening arrhythmias terminated by high-voltage shock are understandably distressing to patients and have been shown to increase levels of fear or anxiety in these patients (Hegel, Griegel, Black, Goulden, & Ozahowski, 1997; Herrman, von zur Muhen, Schaumann, Buss, Kemper, Wantzen, & Gonska, 1997; Keren, Aarons, & Veltri, 1991; Konstam, Colburn, & Butts, 1995; Luderitz, Jung, Deister, & Manz, 1996; Schuster, Phillips, Dillon, & Tomich, 1998; Sears, Todaro, Lewis, Sotile, & Conti, 1999). In fact, ICD-related fears are considered universal and appear to be the most pervasive psychosocial difficulty that ICD patients experience (Sears & Conti, 2002).

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3 ICD patients may begin to think about and become anxious about death due to these life-threatening experiences (Badger & Morris, 1989; Sneed & Finch, 1992). Spouses and family members of ICD patients also experience fears and anxiety about the shocks and about losing their loved one (Badger & Morris, 1989; Morris, Badger, Chmielewski, Berger, & Goldberg, 1991; Sneed & Finch, 1992; Sneed, Finch, & Leman, 1994). These anxieties about death and the ICD may have a negative influence on both the patient's and the spouse's adjustment to the ICD, because of the meaning that ICD shocks hold about the life-threatening nature of this cardiac condition. Hence, death anxiety and shock anxiety can be seen as important aspects of psychosocial adjustment to the ICD for both the patient and the spouse. Adjustment to an ICD and its shocks involves changes in both the patients’ and their loved ones’ psychological, marital, and behavioral functioning. However, at this time no studies have examined all these key concepts among ICD patients and their spouses. Therefore, the main objective of the current study was to examine the relationships among ICD shocks, death anxiety, and shock anxiety; and to examine the resultant effects of these anxieties on patient and spouse psychological, marital, and behavioral adjustment.

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CHAPTER 2 LITERATURE REVIEW The following sections review literature as it applies to ICD patients’ and their spouses’ adjustment to the ICD. The psychological, behavioral, and marital components of adjustment to ICDs for patients and their spouses are addressed. Death Anxiety Introduction and Definition Acknowledging one’s eventual mortality is a common human challenge. Some have suggested that human beings have always feared death; it is society’s method of coping with death and dying that has changed over time (Kubler-Ross, 1996). Death anxiety is the anticipation of a state in which the self or a loved one does not exist, which is variable in intensity over time (Tomer & Eliason, 2000). Death anxiety is a multidimensional construct hypothesized to be composed of four components: (1) Cognitive-Affective, (2) Physical Alterations, (3) Awareness of Rapidly Passing Time, and (4) Stressors and Pain (Lonetto & Templer, 1986). This theory of death anxiety can be applied to research that seeks to operationalize the concept and objectively look at death anxiety, such as the research conducted by cognitive-behavioral psychologists. While the actual names of the factors of death anxiety vary, the general make up and definition of each of the factors are as follows: Cognitive affective. The first factor is described as tying together both the cognitive and emotional impact of death and dying. This aspect of death anxiety may behaviorally manifest in a person showing concern about being afraid to die, being nervous when others discuss death, having frequent thoughts about death, and being troubled about thoughts about life after death and the future. 4

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5 Physical changes. The second factor focuses on a person’s anticipation or fears of the physical changes or sensations, both real and imagined that are associated with dying and serious illness. Behaviors related to this factor may manifest in concerns about having an operation and/or the viewing of a corpse. Awareness of time. The third factor is the awareness of the rapid passing of time, which makes the past and the future feel shortened and the present feel elongated. These concerns may manifest in a person who is distressed by thinking about how rapidly time passes and about how short life really is. Stress and pain. The final agreed upon factor of death anxiety includes the imagined and real stress and pain that are caused by chronic/terminal illness and fears of dying (Lonetto & Templer, 1986). These concerns are revealed in a person’s concerns about dying a painful death, being diagnosed with cancer, having a heart attack, and reacting to discussions about death and dying. Death anxiety is also described as a dynamic state that can change through experience or education of an individual. For example, intimate interpersonal relationships may affect a person’s death anxiety, which can be seen in the finding that husbands and wives often report similar levels of death anxiety (Lonetto & Templer, 1986). Gender also has an effect on the experience of death anxiety. For example, it has been consistently found that women report higher levels of death anxiety (Schulz, 1979). In early research, this gender difference has been seen in multiple populations of men and women; including students, parents, psychiatric patients, and hospital staff (Templer, Ruff, & Franks, 1971). However, there has been little research in this area recently. For many people, feelings of death anxiety may not be a part of their everyday thoughts; however, it is considered fundamental to human existence (Kastenbaum, 2000). Part of being human is knowing that death is inevitable. Thus, feelings of death anxiety become a part of consciousness for many, especially as age increases or when faced with a life-threatening experience, such as sudden cardiac death and ICD shocks. This life-threatening experience is likely to increase levels of death anxiety in ICD patients and their spouses, by forcing them to face their own and their loved ones’ mortality in a way

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6 that they may not have previously. To date, no studies have examined the impact of death anxiety on patient and spouse adjustment to ICD placement. Behavioral Manifestations High levels of death anxiety may lead to avoidance of behaviors that are necessary for the maintenance of a person’s health but can also further heighten death anxiety (Lonetto & Templer, 1986). For example, people with chronic health conditions, such as an ICD patient, may avoid going to doctor appointments for fear of getting bad news. Similarly, they may avoid taking medication or changing behaviors for fear of accepting that they have a serious medical condition. These behaviors can be described as microsuicidal, in that they slowly lead to death by reducing the healthy behaviors or adding unhealthy behaviors into their daily lives (Firestone, 2000). Firestone (2000) proposed 5 different behavioral manifestations of microsuicide in older people: Withdrawal. Increased withdrawal into isolation and retreat into oneself is observed. For example, withdrawal from or significant negative changes in close interpersonal relationships and a lack of concern with one’s environment. Negative health behavior. Engaging in behavior that adversely affects physical health and wellness. Perceived weakness and deterioration of health can be the basis for self-deprecatory thoughts and feelings in the elderly. The behaviors that may result from these feelings include alcoholism, avoiding physician visits, and lack of compliance behaviors. For cardiac and ICD patients, these life-risking behaviors may include medication noncompliance, suicidal ideation, and requests to remove or turn off the ICD. Marital dysfunction. Forming unhealthy interaction styles within significant interpersonal relationships that makes the person feel badly about themselves but yet still depend on the other for health reasons (Firestone, 2000). The more rejection older individuals experience in the marital relationship, the more they cling to the dependency of the relationship due to low self-confidence. This ultimately leads to them feeling negatively about themselves. Withholding. Often these persons withhold qualities of themselves that they previously considered likeable because of reduced feelings of confidence or increased feelings of worthlessness. This is likely to create stress in marital or

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7 other interpersonal relationships and eventually may lead to less social support for the patient. Self denial. Progressive self-denial occurs in patients who are microsuicidal, including giving up interest in life-affirming activities. This last expression can be observed in a lack of interest in or participation in enjoying life or any activity that brings them happiness, such as spending time with their spouse or other family members. Collectively, these microsuicidal behaviors could manifest themselves in diverse ways that span ICD patients’ and spouses’ emotional, marital, and behavioral adjustment to ICD placement. We suspect that the fear of ICD shocks and death can be blamed as the reasons for self-denial, withholding, negative health behaviors, marital dysfunction, and increasing withdrawal. These microsuicidal behaviors may negatively impact multiple areas of functioning. Moderate levels of death anxiety can actually be healthy in an elderly person with a chronic illness, who is often required to endure years of health difficulties, medical compliance requirements, physician visits, and painful medical procedures. Therefore, a moderate amount of death anxiety may provide these patients with the motivation to continue with these tedious or painful events/ requirements; whereas a person with low death anxiety may lose the desire to continue fighting the illness. Spouses are often caregivers for patients with chronic illnesses and therefore it is probable that a moderate level of death anxiety is actually beneficial for them as well. Due to the chronic stress that is imposed on the long-term care-giving spouse, a moderate level of death anxiety may be optimal to provide spouses with the motivation to continue with their care-giving duties.

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8 Death Anxiety Theory The first and original psychological theory related to death anxiety was proposed by Sigmund Freud. He postulated that our unconscious is not ready or able to believe in death of the self. Therefore, death anxiety actually presents itself as some other fear or anxiety that is cloaked in death’s clothing (Kastenbaum, 2000). Freud’s theory suggests that death anxiety is actually an outward signal of difficulty with basic life drives. According to Freud’s theory on death anxiety, it is expected that people will experience death anxiety at some point during their lives; and that these thoughts and anxieties should lead us to a better and more enlightened way of life, due to the revelations these anxieties produce for us about our internal conflicts and fears (Kastenbaum, 2000). Another death anxiety theorist, Ernest Becker (1973), proposed that death anxiety is actually the core anxiety of human existence; and that any and all anxiety is based on death anxiety. Additionally, Becker suggests that death anxiety is actually a normal reaction to death and dying, but that society and/or culture teaches people to ignore this anxiety. If a person experiences a traumatic or life-threatening event in their life, they are often confronted by this death anxiety and are no longer able to ignore it, which results in increased levels of death anxiety (Kastenbaum, 2000). Becker suggests that a method of controlling death anxiety individually is to balance the awareness of individual mortality and death anxiety, so that each person is able to fully develop himself or herself. According to the humanistic theories of death anxiety, self-actualized persons have little fear or anxiety about dying. This is a result of the self-actualized person’s total openness to experiences and feelings. However, most people are not self-actualized; and therefore will experience some level of death anxiety, because dying will be considered a

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9 threat. A self-actualized person may find death an interesting experience, because they have achieved all that they can in this world (Maslow, 1970). Personal Construct Theory postulates that the meaning of death is gathered by a person’s life experiences. As someone experiences life, they gather their own personal meaning and construct of death and dying. However, death is difficult to conceive and define, therefore, the person will likely experience death anxiety until the personal meaning of death and dying is constructed (Tomer, 1992). Religion has also had a significant influence on death anxiety theory (Kastenbaum, 2000). Most of the scientific research literature focuses on the Christian religion and its views on death and dying. Christian religion suggests that death is welcomed because it brings a person closer to God. Conversely, Christian religions also teach that death may be feared if one has not lived a Christian life. Christian religions often combine the feared and anticipated aspects of death to create a very complicated view of dying and death. Therefore, it is easy to understand the conflicting findings regarding death anxiety and any religion (Schulz, 1979). Overall, the research seems to show that the more religious a person is and the stronger their belief in the afterlife the less death anxiety they experience (Schulz, 1979). This complicated view of death within religious frameworks may explain why persons who are less dedicated to their religion experience higher levels of death anxiety than nonreligious persons (Wass & Myers, 1982). In this section the aspects and theories of death anxiety have been discussed as they apply to ICD patients’ and their spouses’ experiences with life threatening illnesses and shocks and the resulting impact on their psychosocial functioning. The following section addresses the anxiety that ICD patients and their spouses experience related to shocks.

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10 Shock Anxiety Within the first year of implantation, approximately 40 to 42% of patients who receive an ICD will receive a shock. Approximately 22% will experience more than 1 shock, and 17% will receive more than 3 shocks (Credner, Klingenheben, Mauss, Sticherling, & Hohnloser, 1998). ICD patients who experience more than 5 ICD firings within the first year after implantation, and patients younger than 50 years old, are at an increased risk for anxiety and ICD-specific fears (Irvine, Dorian, Baker, O’Brien, Roberts, Gent, Newman, & Connolly, 2002; Luderitz, Jung, Deister, & Manz, 1996; Schron, 2002; Sears et al., 1999). Heller, Ormont, Lidagoster, Sciacca, & Steinberg, (1998) reported that shocks were associated with anxiety about family, fewer new activities, increased sadness, fatigue, and nervousness. ICD shocks are the most significant contributor to psychological distress in both ICD patients and their spouses (Morris et al., 1991; Sears et al., 1999; Sears & Conti, 2002). Sears & Conti (2002) state that patients who experience a high number of ICD firings are a group at risk for increased psychosocial difficulties. Patients at an even greater risk for developing psychological difficulties are those who experience an ICD Storm, which is when a patient receives more than 3 shocks within 24 hours (Credner et al., 1998). Credner et al. (1998) found that approximately 10% of ICD patients will experience an ICD Storm within the first year after implantation. This group of patients is at high risk for developing catastrophic thought patterns and feelings of helplessness regarding shocks (Sears & Conti, 2002). Recent research indicated that ICD patients who receive shocks experience more depression, anxiety, and panic disorders; and have overall poorer adjustment to the device than patients who do not receive any shocks (Godeman, Butter, Lampe, Linden, Schlegl,

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11 Schultheiss, & Behrens, 2004; Kohn, Petrucci, Baessler, Soto, & Movsovitz, 2000). Experimental research that exposed ICD patients to mental stress, such as mental arithmetic and anger recall, produced ventricular arrhythmias in these patients (Kop, Krantz, Nearing, Gottdiener, Quigley, O’Callahan, DelNegro, Friehling, Karasik, Suchday, Levine, & Verrier, 2004). This ground-breaking research demonstrates that mental stress, anxiety, and anger may cause arrhythmias, further causing the ICD to administer shocks to the patient (Kop et al., 2004; Lampert, Jain, Burg, Batsford, & McPherson, 2000). These results justify further research related to psychological sequellae in ICD patients and emphasize the biopsychosocial nature of cardiac arrhythmias and ICD treatment. Cognitive Appraisal of ICD Activity. Sears et al. (1999) proposed a psychological theory, Cognitive Appraisal of ICD Activity, explaining attempts by some ICD recipients to seek greater perceived control over ICD shocks. This is accomplished by interpreting the activity of the ICD as an indicator of their current cardiac functioning. Sears et al. (1999) also suggested that ICD patients tend to keep score of the recent actions of their ICD. Psychological benefit can be gained by attempting to control this unpredictable arrhythmic disease. However, the validity of the patients’ beliefs can be false and may lead to psychosocial distress and eventual conflict with their health care providers. The patients’ loved ones may also begin to appraise the ICD activity in a similar manner, resulting in increased conflict in close interpersonal relationships for the patients, and elevated levels of psychological distress in family members. Research has now provided evidence to support this theory, by demonstrating that the intensity of patients’ observations of their device and bodies, increased their risk of developing

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12 anxiety disorders (Godeman et al., 2004). Therefore, it is believed that the occurrence of shocks may prompt negative appraisals, reduce perceived control, and increase pain reports; further resulting in increased anxiety for both the patient and their family members. General Anxiety General anxiety is the most frequently assessed psychological variable in ICD patients. Clinically diagnosable levels of general anxiety, ranging from 13 to 38%, have been found in most studies; therefore, it appears to be a commonly experienced psychological problem for many ICD patients (Hegel et al., 1997; Herrman et al., 1997; Keren, Aarons, & Veltri, 1991; Konstam, Colburn, & Butts, 1995; Luderitz, et al., 1996; Schuster, et al., 1998; Sears et al., 1999). Family members and spouses of ICD patients also experience elevated levels of anxiety and fear because of concerns about the patient’s health and the possibility of death (Dougherty, 1995; Dougherty, Pyper, & Benoliel, 2004; Dunbar, Warner, & Purcell, 1993; Morris et al., 1991; Pycha, Gulledge, Hutzler, Kadri, & Maloney, 1986; Sneed & Finch, 1992;). The experience of ICD firings is generally faulted as a precipitant of anxiety in ICD patients (Heller et al., 1998). Dunbar, Warner, and Purcell (1993) reported that 87% of the patients who had experienced ICD firings also reported “nervousness” as a result of ICD firings. Patients who have received ICD firings have significantly higher levels of anxiety than patients without a history of firings (Dougherty, 1995; Herrman et al., 1997; Luderitz et al., 1996). Avoidance Behaviors In recent empirical work, Sears et al. (1999) conducted a national survey of ICD patients and spouses (NSIRSO) who had been implanted with an ICD in the previous

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13 year. This study represents the largest, random, national sample of ICD patients examining psychosocial variables. Results indicated that adjustment concerns (such as generalized fear, worry, fear of physical exertion, and depression) were significantly higher for patients who had been shocked. Approximately one-third of older patients (>65 years old) in this study endorsed specific fears about lifestyle issues including physical exertion, performance of household duties, and sexual activity. Additionally, Heller et al. (1998) reported that once ICD patients receive a shock, they are less likely to engage in new activities. Based on this research it appears that many patients attempt to reduce their chances of receiving a shock by reducing the number and frequency of activities that increase heart rate. Lemon, Edelman, & Kirkness (2004) found that approximately 55% of ICD patients engaged in some sort of avoidance of specific activities. Interestingly though, little evidence was found of a relationship between avoidance behaviors and ICD shocks in these patients. Other recent research demonstrated that shocks and catastrophic cognitions contributed to the development of avoidance behaviors (Godeman et al., 2004). All of these studies suggest that cognitions also play an important role in the development of avoidance behaviors in ICD patients. Spouses of ICD patients often face similar challenges after implantation; however, they have even less control over the situation, and may be more vulnerable to distress related to the patient’s avoidance behaviors. In general, most cardiologists do not discourage ICD patients from returning to most daily activities; however, patients often limit themselves because of fear of shocks. ICD patients often believe that if they do not increase their heart rate, they will be less likely to receive a shock; unfortunately, this is not the case. As can be seen from

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14 NSIRSO, patients avoid activities they fear may cause a shock, and spouses also worry about the patients engaging in these behaviors (Sears et al., 1999). The resultant declines in physical activity level and functioning are associated with negative changes in mood and the development of depression in ICD patients (Pycha et al., 1986). Classical Conditioning. The psychological theory of classical conditioning provides a framework to help explain the avoidance behaviors that ICD patients engage in (Sears et al., 1999). Classical conditioning was discovered by Ivan Pavlov while he was conducting research with dogs. During this research, dogs were repeatedly presented with an unconditional stimulus paired with a neutral stimulus, and eventually the neutral stimulus produced conditioned physiological or behavioral responses (Wolpe & Plaud, 1997). This classical conditioning paradigm is currently used to explain the learning of phobias and fear responses to negative events (Barlow, 1988). ICD patients experience similar conditioning when the ICD fires and causes feelings of anxiety and sometimes physical pain. Neutral stimuli (such as the pre-shock activity, behaviors, or emotions), when paired with ICD firings over time, may eventually be associated with the anxiety originally linked to the firings. Subsequently, those stimuli are avoided because of their association with the aversive event. Lemon, Edelman, & Kirkness (2004) showed that the classical conditioning model cannot fully explain this complex pattern of behaviors, emotions, and cognitions in ICD patients. This research has shown that the cognitions and cognitive coping style of ICD patients have more impact than ICD shocks on anxiety levels. In fact, it was found that cognitive distortions related to the ICD rather than actual ICD firings were associated with increased anxiety in ICD patients (Lemon, Edelman, & Kirkness, 2004). It can be

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15 postulated based on this research that the patients’ and their spouses’ cognitive style may have more of an impact on avoidance behaviors than even an actual ICD shock. Avoidance behaviors and fears of cardiac stress continue to be studied and found to be significant concerns for ICD patients and their spouses. These concerns should be addressed because of the relationship between avoidance behaviors and physical and emotional health. Marital Satisfaction Because of the increased psychosocial difficulties many ICD patients and their spouses experience after ICD implantation, marital satisfaction may also be impacted, further impairing adjustment after a life-threatening event or illness (Pycha et al., 1986; Sneed & Finch, 1992). Spouses of ICD patients have reported concern about caring for the patient safely at home and understanding what the ICD does to treat arrhythmias (Dougherty, Pyper, & Benoliel, 2004). Equally important to the spouses of ICD patients, was taking care of themselves and managing the stress that accompanies care-giving duties (Dougherty, Pyper, & Benoliel, 2004). The majority of couples report that they are generally satisfied with their marriage after an acute cardiac event (Hilbert, 1996; Meddin & Brelje, 1983; Thompson, Ersser, & Webster, 1994). Conversely, some patients and their spouses report negative changes in the marital relationship, such as less openness in the marriage and less beneficial coping strategies being utilized after a cardiac event (Arefjord, Hallaraker, Havik, & Maeland, 1998). At 10-year follow up, the spouses in this study also reported that the Myocardial Infarction (MI) had a long-term negative effect on their marital quality as a result of these difficulties, thereby demonstrating the long-term effects of a cardiac event on a marital relationship (Arefjord et al., 1998). Meddin & Brelje (1983) found that post-MI, 40% of spouses reported a positive period

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16 when the husband was recuperating; but only if they had significant assistance and support during this time period. Marital relationships may be enhanced by coming together during a life-threatening crisis, which may result in positive views of the future after an acute cardiac event (Thompson, Ersser, & Webster, 1994). Overall, most studies have found reduced marital satisfaction and functioning after an acute cardiac event, especially for the spouse. However, significant social support appears to act as a buffer against marital dysfunction during these life-threatening cardiac events. These findings regarding general cardiac patients and their spouses provide evidence that the spouses of ICD patients may actually report more marital difficulty than patients do after ICD implantation. Internet-Based Assessment All of the previously reviewed variables were available to participants in this project through utilizing an Internet-based assessment methodology in attempt to include as many patients and spouses as possible. However, if participants were unable or unwilling to complete the assessments online, they were allowed to participate via paper-based questionnaires. ICD patients and their spouses were recruited from multiple clinic sites; but completed the same assessment to increase participation, validity, and reliability. Therefore, the following section addresses Internet use and assessment as they apply to ICD patients and their spouses. With the increase in web-based technology and Internet use over the past 20 years has come an increased ability to provide and deliver psychological assessments and information over the Internet to healthcare consumers. Internet-based assessments have established the ability of the computer to be reliable, flexible, and private; to reduce patient embarrassment, and to provide improved validity in psychological assessments

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17 (Erdman, 1985). In fact, computers and Internet-based assessments may provide enough anonymity to elicit more valid and honest responses to personal questions, such as those assessed with psychological measures (Carr, Ghosh, & Ancill, 1983; Greist, Gustafson, Strauss, Rowse, Laughren, & Chiles, 1973; Greist., Klein, Erdman, & Jefferson, 1983; Lucas, Mullin, Luna, & McInroy, 1977). Internet usage is growing rapidly and it is predicted that in 2004 there will be 210 million Internet users worldwide. The Internet is also a heavily used tool for health information dissemination and gathering (Pew Internet, 2000). As of November 2001, 62% of all U.S. households had Internet access, with 110 million people accessing the Internet for health-related information (NetRatings, 2001; Pew Internet, 2000). The majority of ICD patients and their spouses are ages 65 and older and nearly 20% of individuals in this age group and approximately 50% of persons between the ages of 45 and 64 have home Internet access (U.S. Census Bureau, Current Population Survey, August 2000). Although, the age group of 65 and older does not represent the most active group of Internet users, a significant number of them are using the Internet in their home; and an even greater proportion of the younger age group are utilizing the Internet as well. ICD patients and their spouses may also obtain Internet access through family members in the younger age groups, of which approximately 53% have Internet access in their home (U.S. Census Bureau, Current Population Survey, August 2000). These statistics demonstrate that a web-based assessment is accessible and acceptable for a proportion of patients with ICDs and their spouses. Aims and Study Justification This review of the relevant literature suggests that ICD patients’ and their spouses’ adjustment to the ICD have not been thoroughly assessed. Death anxiety is a component

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18 that has been neglected in this patient population and may provide beneficial information regarding how the patients and their spouses conceptualize and cope with ICDs and shocks. The unique format of the Internet based assessments and paper based assessments allows for multiple methods of participation by a group of patients that may not otherwise have the opportunity to participate in this type of research because of the limited amount of research being conducted in this population. Death anxiety is an umbrella term that encompasses multiple sub-components. In this investigation, it is suggested that shock anxiety is a sub-component of death anxiety. More specifically, it is suggested that shock anxiety is related to the fear of real and/or imagined physical pain and stress sub-component of death anxiety. Shock anxiety may be the gateway to death anxiety for ICD patients and their spouses. ICD patients and their spouses may be better able to identify their anxiety as it relates to shocks. However, due to the lack of research on death anxiety in ICD patients and their spouses; it is unknown at this time just how much death anxiety they actually experience, and what effects death anxiety has on their adjustment to ICD treatment and marital functioning. Spouses of general cardiac patients have been shown to report lower marital satisfaction and more over all distress than the patients (Arefjord et al., 1998; Hilbert, 1996; O’Farrell, Murray, & Hotz, 2000; Thompson, Ersser, & Webster, 1994). Therefore, there is evidence to predict that spouses of ICD patients may actually experience more distress and reduced marital satisfaction than the patients. The spouse of an ICD patient is the most important part of their support and care-taking group and spouses report that caring for the patient after ICD implantation is a major concern (Dougherty, Pyper, & Benoliel, 2004). Understanding spousal functioning after ICD

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19 implantation is imperative to understanding the patient’s functioning, adjustment, and the marital relationship. This study is unique in its attempt to provide some insight into the effects of ICD placement and shocks on death anxiety and shock anxiety; and the resulting psychological, marital, and behavioral adjustment in both ICD patients and their spouses. Understanding how death anxiety and shock anxiety are related to the ICD, and patient, and spousal psychosocial adjustment may provide clinicians with information to better prepare patients and spouses for ICD placement, and how to cope with ICD shocks if they occur. The results of the proposed study related to avoidance behaviors may be utilized to help health care providers better understand, proactively intervene and possibly change avoidance behaviors before and after receiving a shock; thereby increasing quality of life, activity levels, and physical functioning. Findings from this research will also be helpful in the design and implementation of computer and web-based psycho-educational interventions for both ICD patients and their spouses. Finally, the original format of an Internet-based assessment option for ICD patients and their spouses may provide future researchers with a new method of conducting multi-center research and reaching new samples of patients that may have otherwise been ignored. Therefore, the purposes of the proposed study were to examine the effects of ICD placement and shocks on death anxiety and shock anxiety; and the resultant effects of these anxieties on patient and spouse psychological, marital, and behavioral adjustment. Hypotheses Question 1 Do patients or spouses experience more shock, death, and general anxiety?

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20 Hypothesis 1. Spouses will report more shock, death, and general anxiety than patients. Participants. All patients and spouses Analysis. Hierarchical regressions will be performed to test whether patients or their spouses experience more shock, death or general anxiety. Table 2-1. Hypothesis 1 Variables Statistical analysis Participants DV = Shock anxiety Death anxiety General anxiety Hierarchical regressions with Bonferroni corrections Patients IV = Patient Spouse Spouses Question 2 Do shock anxiety, death anxiety, and general anxiety lead to increased avoidance behaviors in ICD patients? Hypothesis 2. Higher levels of shock anxiety, death anxiety, and general anxiety lead to increased avoidance behaviors in ICD patients. Participants. All patients Analysis. A hierarchical regression will be performed to determine if shock anxiety, death anxiety, and general anxiety predict avoidance behaviors in ICD patients. Table 2-2. Hypothesis 2 Variables Statistical analysis Participants DV= Avoidance behaviors Hierarchical regression Patients IV = Shock anxiety Death anxiety General anxiety Question 3 Does history of shock increase shock anxiety, death anxiety, general anxiety, and marital dysfunction in patients and their spouses?

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21 Hypothesis 3. History of shocks is associated with increased shock anxiety, death anxiety, general anxiety, and marital dysfunction in patients and spouses. Participants. All patients and spouses Analysis. Hierarchical regressions will be utilized to assess whether shocks are associated with significantly higher levels of shock anxiety, death anxiety, general anxiety, and marital dysfunction in patients and their spouses. Table 2-3. Hypothesis 3 Variables Statistical analysis Participants DV = Shock anxiety Death anxiety General anxiety Marital dysfunction Hierarchical regressions with Bonferroni corrections Patients IV = Shocks Spouses Question 4 Does method of evaluation affect the self-report of psychosocial difficulties in patients and spouses? Hypothesis 4. No difference will be found in the amount or type of information revealed in either method of evaluation. Participants. All patients and spouses Analysis. A MANOVA will be performed to determine if method of evaluation affects the amount and type of information revealed by patients and spouses. Table 2-4. Hypothesis 4 Variables Statistical analysis Participants DV = Death anxiety Shock anxiety General anxiety Avoidance behaviors Marital satisfaction MANOVA Patients IV = Method of assessment Spouses

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22 Question 5 Are there differences in scores of shock anxiety, death anxiety, general anxiety, marital satisfaction, and avoidance behaviors reported between baseline and follow-up assessments? Hypothesis 5. No significant difference will be found in the scores between baseline and follow-up assessments. Participants. All patients and spouses Analysis. Repeated measures MANOVA will be performed to assess whether there is a difference between baseline and follow-up assessments in patients and their spouses. Table 2-5. Hypothesis 5 Variables Statistical analysis Participants Point of analysis DV = Shock anxiety Death anxiety General anxiety Avoidance behaviors Marital satisfaction Repeated measures MANOVA Patients Pre-post test IV = Baseline assessment Follow-up assessment Spouses

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CHAPTER 3 METHOD Sample All of the ICD patients and their spouses in this study were recruited at the University of Florida Health Science Center, were older than 18 years of age; and speak, and read English. Forty-six ICD patients and twenty-six spouses agreed to participate in this research project for a total of 72 participants. However, some patients and their spouses were unable to complete the questionnaires because of unavailable or incomplete contact information (5 patients, 3 spouses) or they no longer had an ICD (1 patient, 1 spouse). The total number of patients who completed the baseline evaluations for this research project was 40, and the number of spouses was 22; for a total of 62 participants utilized in the statistical analyses. A change in the research protocol was required in the interim of this project because none of the ICD patients in this study received a shock from the ICD during the 6-month follow-up period. Hence, only data from the baseline evaluation will be utilized in the statistical analyses. Despite this change 18 patients and 11 spouses completed the 6-month follow-up questionnaires for this study and this data will be utilized to ensure that no changes occurred in the psychosocial variables over the 6-month follow-up period. Approximately 27% of the patients received shocks prior to participation in this research project, with a mean of just under 1 shock (SD = 1.99). This information about pre-morbid ICD shocks was utilized in lieu of the interim shocks in the statistical analyses, so that the effects of ICD shocks were still assessed in this project. This lack of 23

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24 ICD shocks is surprising and is likely due to improved device technology, increased medical knowledge of appropriate settings for the device, and improved selection of appropriate candidates for implantation of the ICD. Demographic data for the ICD patients who completed the baseline evaluations consist of the following: 31 males and 9 females; with a mean age of 66, (SD = 11.28). Approximately, 77% of patients are retired and 82% at least completed their high school education. Demographics for the spouses consist of the following: 3 males and 19 females; with a mean age of 66, (SD = 12.02). Fifty-eight percent of spouses are retired and all but one at least completed a high school education. Eighty-seven percent of the total participant group are married; 3% are divorced, and 10% are widowed or single. The majority of the sample was Caucasian (94%); two were African-American, one participant was Hispanic, and one was American Indian. Table 3-6 provides the complete demographic information for this sample of ICD patients and their spouses. ICD patients’ medical records were reviewed to obtain the following information. Mean time since ICD implantation was 28 months (SD = 30). These ICD patients had an average of 2 cardiac diagnoses; sixty-five percent of ICD patients were diagnosed with Ischemic Cardiomyopathy, 30% were diagnosed with Ventricular Fibrillation, 50% were diagnosed with Ventricular Tachycardia, 50% were diagnosed with Coronary Artery Disease, 35% were diagnosed with Atrial Fibrillation, 15% were diagnosed with Congestive Heart Failure, and 3% were diagnosed with Hypertrophic Cardiomyopathy. These ICD patients were prescribed an average of 5.63 cardiac medications; with approximately 75% of the patients taking somewhere between 4 and 7 cardiac medications. This sample of ICD patients had an average Ejection Fraction of

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25 approximately 25.44% (SD = 11.49). Table 3-7 provides complete data on medical variables for the ICD patients. No significant difference was found in demographics between the patients who were unable to complete this project and patients who remained in this study [F(1,71)= .255, p= .954]. Table 3-6. Patient and spouse demographic characteristics Demographic Patients (n =40) Demographic Spouses (n =22) Gender Male Female 77.5% 22.5% Gender Male Female 13.6% 86.4% Age Under 40 41-50 51-60 61-70 Over 70 2.5% 7.5% 17.5% 25.0% 47.5% Age Under 40 41-50 51-60 61-70 Over 70 0.0% 15.0% 20.0% 30.0% 35.0% Education level Elementary school Some high school High school Some college Bachelor’s degree Graduate education 6.1% 12.1% 21.2% 15.2% 27.3% 18.2% Education level Elementary school Some high school High school Some college Bachelor’s degree Graduate education 0.0% 5.3% 31.6% 31.6% 10.5% 21.1% Employment status Full time Part time Not employed Retired 5.9% 5.9% 11.8% 76.5% Employment status Full time Part time Not employed Retired 21.1% 10.5% 10.5% 57.9% Marital status (combined patients and spouses) Married 87.1% Single 3.2% Divorced 3.2% Widowed 6.5% Separated 0.0%

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26 Table 3-6. Continued Demographic Patients (n =40) Demographic Spouses (n =22) Religion (combined patients and spouses) Protestant 40.4% Catholic 19.1% Christian 21.3% Jewish 00.0% Other 19.1% Method of evaluation (combined patients and spouses) Internet 21.0% Paper 79.0% Table 3-7. Patient medical variables Medical variables Patients (n =40) Number of previous shocks 0 1 2 3 5 10 73.0% 10.0% 2.5% 7.5% 5.0% 2.5% Cardiac diagnoses Ischemic cardiomyopathy Ventricular fibrillation Ventricular tachycardia Coronary artery disease Atrial fibrillation Congestive heart failure Hypertrophic cardiomyopathy 65% 30% 50% 50% 35% 15% 3% Number of cardiac medications 1 2 3 4 5 6 7 8 9 10 2.6% 0.0% 5.3% 18.4% 15.8% 34.2% 10.5% 7.9% 2.6% 2.6%

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27 Table 3-7. Continued Medical variables Patients (n =40) Ejection fraction (reported as a percentage) 10 15 18 20 25 30 35 40 45 48 55 8.3% 19.4% 2.8% 22.2% 5.6% 16.7% 11.1% 2.8% 5.6% 2.8% 2.8% Procedure This group of ICD patients and their spouses were recruited during the patient’s outpatient cardiac clinic appointment or directly after ICD implantation. After an introduction of the study and the gathering of informed consent, the patients and their spouses were provided with an option to participate on the Internet or on paper. Participants’ medical records were reviewed at this time for information regarding cardiac illnesses, cardiac medications, and ICD specific data. If the participants chose the Internet-based assessment, then they were provided with a password and an informational handout about the study. Participants (spouses and patients) then logged onto the secure password protected website and completed an initial psychosocial assessment that took approximately 20-30 minutes to complete. If the patient and/or spouse chose to participate via paper-based questionnaires, then they were provided with the paper questionnaires, and asked to complete the forms and return them to the researcher prior to leaving the clinic. Occasionally, if time was

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28 limited in the clinic, participants were allowed to complete the questionnaires at home and then mail them in. The spouses and patients each completed individual psychological assessment batteries; which took approximately 20-30 minutes to complete. Upon completion and submission of these baseline assessment questionnaires online or on paper, the patient and their spouse were instructed to call the cardiac clinic staff within 48 hours after the patient had received an ICD shock. At that time they would have been directed to return to the website or were supposed to be sent another set of follow-up questionnaires. During the course of this project no ICD patients were shocked; therefore, this protocol was not possible and the data from baseline evaluations was utilized instead. Data from the participants in this study who completed the 6-month follow-up assessment were utilized to ensure that no changes occurred during the follow-up period. This follow-up assessment was comprised of the same materials as the baseline assessment and took approximately 20-30 minutes. Immediately after the follow-up assessment, participants were provided with a brief CD-ROM based psycho-educational program as compensation for participation in this project. This program included educational information regarding anxiety, avoidance behavior, and ICD shocks that are pertinent to ICD patients. Information regarding how to cope with these anxieties, change their behavior, and improving marital functioning were also a component of the CD-ROM based psycho-educational program. Only baseline assessment data will be used in the statistical analyses for this research project due to the lack of ICD shocks between baseline and follow-up assessments. It is expected that there will be no changes in any of the psychosocial

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29 variables over time because no ICD shocks occurred during this follow-up period. Only reliability and validity testing for the Shock Anxiety Survey and comparison analyses on the psychosocial variables will be conducted utilizing the follow-up data that was collected. Measures Death Anxiety Multidimensional Fear of Death Scale (MFODS). The MFODS is a 42-item assessment device with 5-point Likert response formatting (Neimeyer & Moore, 1994). This scale is composed of eight factors: (1) Fear of the dying process, (2) Fear of the dead, (3) Fear of being destroyed, (4) Fear for significant others, (5) Fear of the Unknown, (6) Fear of conscious death, (7) Fear of the body after death, and (8) Fear of premature death (Neimeyer & Moore, 1994). For this study only the Fear of the Dying Process (6 items) and Fear of Premature Death (4 items) Scales will be used. The range of scores for the whole measure is from 42 to 210, with lower scores indicating higher death anxiety. Previous research has calculated the Cronbach’s alpha of reliability at .85 (Neimeyer & Moore, 1994). In this study, it was found to have a Cronbach’s alpha of .9177. Shock Anxiety Shock Anxiety Survey (SAS). This measure was developed by the principal investigator to assess the fear and anxiety that patients and their spouses may have regarding the ICD and its shocks. This 10-item measure examines the cognitive, behavioral, emotional and social impacts of shock anxiety and has both a patient and a spouse version. The reliability and validity of this measure were evaluated in this project. This information will be discussed in the results section.

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30 General Anxiety State Trait Personality Inventory (STPI). The STPI is a 60-item self-report questionnaire that measures state and trait personality characteristics that consists of 4 scales: depression, anxiety, curiosity, and anger (Spielberger, 1979). For this study only the 7-item trait anxiety scale will be used. The Cronbach’s alpha for this study was found to be .7182. Avoidance Behaviors Triggers of Ventricular Arrhythmias Usual Activity and Mood Questionnaire. This 13-item measure was used in the Triggers of Ventricular Arrhythmias Study to assess a patient’s usual activity level and normal mood both before and after ICD shocks. The measure assesses the patient’s emotions, physical activities, and drug and alcohol use. This measure will be utilized in this study to assess the behavioral factors that are involved in avoidance of ICD shocks. In this study, the Cronbach’s alpha was .7859. Marital Functioning Dyadic Adjustment Scale (DAS). The DAS is a 32-item measure of marital adjustment and marital quality (Spanier & Filsinger, 1983). However, for this study only the 10-item satisfaction factor will be used as a general indicator of marital satisfaction (Spanier, 1976). The scale is divided into 4 sub-scales: (1) Affectional Expression, (2) Consensus, (3) Dyadic Cohesion, and (4) Satisfaction. The Likert response format ranges from 0 to 2 and 0 to 5 depending on the item, with a total score of 151 possible. Scores lower than 100 usually suggest marital distress and the total score can be used as an indicator of marital adjustment (Badger, 1992). Internal reliability and a Cronbach’s

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31 coefficient alpha of 0.96 have been established (Spanier, 1976). The Cronbach’s alpha for this study was found to be .9521.

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CHAPTER 4 RESULTS Sample Descriptives Normative data is available in the current research literature for the death anxiety, general anxiety, and marital satisfaction measures, so these results will be discussed in reference to the normative data that is available. ICD patients were found to be significantly different from the normative data on death anxiety (t = 2.305, p = .026); such that ICD patients reported less death anxiety than the general population. No other significant differences were found for marital satisfaction or general anxiety in ICD patients as compared to normative data. No significant differences were found for spouses of ICD patients on any of the psychosocial measures as compared to normative data. Further investigation was desired to better understand the percentages of patients and spouses who may be reporting elevated death anxiety, general anxiety, and reduced marital satisfaction. A cut off point of 1.5 SD above the normative mean was utilized to provide frequency data; because a conservative measure of psychological distress was desired, and this cut off is approximately at the 85th percentile rank. The marital satisfaction levels for these ICD patients and their spouses indicate that they are generally satisfied with their current marriages and are receiving adequate support in their relationships. However, 4.5% of spouses and 6.0% of ICD patients reported levels of marital satisfaction that are 1.5 SD below satisfaction ratings for married people, suggesting that a small percentage of ICD patients and spouses are 32

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33 experiencing diminished marital satisfaction. Approximately 12.5% of ICD patients and 14.4% of their spouses reported elevated fear of death (1.5 SD above normative mean data was used as a cutoff score). Approximately 7.5% of ICD patients also reported elevated levels of general anxiety as compared to normative data, demonstrating that a small group of ICD patients have high levels of general anxiety. Normative data are not available for the shock anxiety and avoidance behaviors measures; however, these results can be qualitatively discussed. The patient reported avoidance behaviors mean was 14.41, (SD = 9.61) and the spouse reported avoidance behaviors mean was 14.80, (SD = 8.95). These means are not necessarily representative of the actual number of avoidance behaviors reported, but instead provide an estimate of the frequency in which these patients engage in particular behaviors or emotions. It can be concluded that patients and spouses appear to agree on the amount of and degree to which ICD patients avoid behaviors, emotions, and situations. In looking at shock anxiety, there is a significant discrepancy between patient and spouse reported levels of distress. The spouse mean score on the SAS was 18.45, (SD = 6.06), while the ICD patient mean score was 14.78, (SD = 7.36), indicating that shock anxiety appears to affect the spouses more than patients. All of these relationships are explored for significant differences in the hypothesized analyses section. Please see Table 4-8 for baseline data regarding psychosocial measures for ICD patients and Table 4-9 for data regarding psychosocial measures for spouses. Table 4-10 (patient) and Table 4-11 (spouse) display data regarding means on psychosocial measures at 6-month follow-up.

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34 Table 4-8. Baseline patient psychosocial measure means M SD n Min. Max. Norms TOVA: Avoidance behaviors 14.41 9.61 39 1 42 N/A MFODS: Death anxiety 33.92 11.52 40 10 50 29.57 SAS: Shock anxiety 14.78 7.36 40 10 47 N/A STPI: General anxiety 17.58 5.25 40 11 36 17.12 DAS: Marital satisfaction 39.21 8.23 33 16 48 40.5 Table 4-9. Baseline spouse psychosocial measure means M SD n Min. Max. Norms TOVA: Avoidance behaviors 14.80 8.95 20 6 38 N/A MFODS: Death anxiety 30.33 9.06 21 14 46 27.21 SAS: Shock anxiety 18.45 6.06 22 13 36 N/A STPI: General anxiety 17.29 4.22 21 11 25 17.12 DAS: Marital satisfaction 41.05 3.73 22 29 46 40.5 Table 4-10. Follow-up patient psychosocial measure means M SD n Min. Max. Norms TOVA: Avoidance behaviors 12.82 12.90 18 1 44 N/A MFODS: Death anxiety 35.12 10.12 18 15 30 29.57

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35 Table 4-10. Continued M SD n Min. Max. Norms SAS: Shock anxiety 15.71 8.04 18 10 39 N/A STPI: General anxiety 17.29 6.84 18 10 36 17.12 DAS: Marital satisfaction 42.06 2.82 18 37 46 40.5 Table 4-11. Follow-up spouse psychosocial measure means M SD n Min. Max. Norms TOVA: Avoidance behaviors 10.27 11.55 11 2 43 N/A MFODS: Death anxiety 31.82 12.63 11 14 50 27.21 SAS: Shock anxiety 16.45 3.08 11 12 21 N/A STPI: General anxiety 16.60 4.72 11 12 24 17.12 DAS: Marital satisfaction 42.91 2.63 11 38 46 40.5 Hypothesized Analyses The following statistical analyses were performed to evaluate the proposed hypotheses for this research project. The Statistical Package for the Social Sciences (SPSS) was utilized to perform all the analyses. When appropriate, Bonferroni corrections were applied to rectify the possibility of Type I error. Family wise error rates are noted for each analysis. This method of correction was utilized in order to provide a conservative and methodical analysis of the data.

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36 Hypothesis 1 Spouses will report more shock anxiety, death anxiety, and general anxiety than patients. Findings. The first group of analyses was conducted to evaluate the effects of participant group (patient and spouse) on the amount of reported shock anxiety, death anxiety, and general anxiety. Data from ICD patients and their spouses were utilized in the following analyses. Three hierarchical regressions were performed to evaluate the differences between ICD patients, and their spouses, and Bonferroni corrections were applied. These analyses controlled for gender and number of shocks. The first hierarchical regression addressed participant group differences in shock anxiety. Gender accounted for 14.5% unique variance and shocks accounted for an additional 9.2% of the variance in shock anxiety [R2 = .145, F(1,60) = 11.367, p = .001] and [R2 = .237, F(2,59) = 10.491, p = .000], respectively. The corrected hypothesized model accounted for 22.4% of the total variance in shock anxiety [R2 = .224, F(3,58) = 6.880, p = .000, Bonferroni correction .05/3 = .02]. This hierarchical regression determined that participant group (patient vs. spouse) did not account for any unique variance in shock anxiety. This analysis displayed evidence that female gender is more important than history of ICD shocks and participant group in predicting anxiety related to ICD shocks. In the death anxiety regression, it was found that participant group did not significantly predict any unique variance. However, gender was found to account for 4.0% and shocks accounted for 9.4% of unique variance in death anxiety [R2 = .040, F(1,59) = 3.484, p = .067] and [R2 = .094, F(2,58) = 4.118, p = .021], respectively. Total variance accounted for in death anxiety by the corrected hypothesized model (participant

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37 group, gender, and shocks) is 7.9% [R2 = .079, F(3,57) = 2.711, p = .05, Bonferroni correction .05/3 = .02]. This death anxiety hierarchical regression was initially found to be statistically significant; however, after Bonferroni corrections were utilized the significance was removed. Conclusions based on this analysis are tenuous until further research can support findings of significance. The third hierarchical regression evaluated the effect of participant group on general anxiety and found no significant differences in the amount of general anxiety reported by ICD patients and their spouses [R2 = .016, F(3,57) = 1.318, p =.277, Bonferroni correction .05/3 = .02]. Overall, the hierarchical regressions evaluating the effects of participant group on reported levels of shock anxiety, death anxiety, and general anxiety demonstrated that there are no significant differences based on participant group (spouse and patient) in these variables. These analyses also suggest that spouses and ICD patients report similar levels of shock anxiety, death anxiety, and general anxiety; despite the fact that the spouses do not have an ICD. Hypothesis 2 Higher levels of shock anxiety, death anxiety, and general anxiety lead to increased avoidance behaviors in ICD patients. Findings. Data from ICD patients were utilized in a hierarchical regression that was performed controlling for the effects of previous ICD shocks. This analysis determined that shock anxiety accounted for 18.4% of the variance in avoidance behaviors in ICD patients. None of the other variables that were entered into the equation (general anxiety, death anxiety, and history of shocks) accounted for any additional variance in avoidance behaviors and did not significantly add to the model. Total

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38 variance accounted for in avoidance behaviors by the hypothesized model was 18.4% [R2 = .184, F(4,34) = 3.135, p =.027]. Interestingly, this analysis demonstrates that the cognitive aspects of shocks (shock anxiety), and the cognitive coping styles of ICD patients, were more important than history of shocks and fear of death in predicting avoidance behaviors in ICD patients. Hypothesis 3 History of shocks is associated with increased shock anxiety, death anxiety, general anxiety, and marital dysfunction in ICD patients and spouses. Findings. Four hierarchical regressions were completed to evaluate the effect of previous ICD shocks on shock anxiety, death anxiety, general anxiety, and marital satisfaction in ICD patients and their spouses. These hierarchical regressions were completed with data from patients and spouses, and Bonferroni corrections were applied. Participant group and gender were controlled for in these analyses. The hierarchical regressions looking at the effects of previous shocks on marital satisfaction and general anxiety were found to be non-significant; which indicates that previous shocks do not significantly affect reported levels of marital satisfaction [R2 = .037, F(3,51) = .362, p = .781, Bonferroni correction .05/4 = .013] and general anxiety [R2 = .016, F(3,57) = 1.318, p = .277, Bonferroni correction .05/4 = .013]. In the regression addressing death anxiety, it was found that previous shocks accounted for 5.5% of unique variance and gender accounted for an additional 4.0% of the variance[R2 = .079, F(3,57) = 2.711, p =.053] and [R2 = .040, F(1,59) = 3.484, p = .067], respectively. Participant group accounted for 2.4% of unique variance [R2 = .064, F(2,58) = 1.727, p = .187]. The total corrected equation accounted for 7.9% of the variance in death anxiety [R2 = .079, F(3,57) =2.711, p =.053, Bonferroni correction .05/4

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39 = .013]. This regression was statistically significant; however, the significance is removed after Bonferroni corrections. Conclusions based on this analysis are tenuous until further research can support significance of findings. The regression evaluating the effects of previous shocks on shock anxiety, determined that shocks accounted for 9.3% of unique variance and gender accounted for an additional 14.5% of the variance [R2 = .224, F(3,58) = 6.880, p = .000] and [R2 = .145, F(1,60) = 11.367, p = .001], respectively. Participant group did not account for any additional variance in shock anxiety [R2 = .000, F(2,59) = 5.590, p = .006]. This corrected equation accounted for 22.4% of the total variance in shock anxiety [R2 = .224, F(3,58) = 6.880, p = .000, Bonferroni correction .05/4 = .013]. This analysis determined that history of shocks and female gender may increase the risk of anxiety and worry about the ICD and shocks. In this group of regressions evaluating the effects of previous ICD shocks on shock anxiety, death anxiety, general anxiety, and marital dysfunction, it was determined that history of shocks and gender are important predictors of shock anxiety, and to less extent death anxiety, in ICD patients and their spouses. Hypothesis 4 No differences related to Internet-based or paper-based evaluations will be found in shock anxiety, death anxiety, general anxiety, avoidance behaviors, or marital satisfaction reported by ICD patients and spouses. Findings. Thirteen participants (approximately 29%) out of the 45 that were offered the opportunity, chose to utilize the Internet based evaluation methodology. A Multivariate Analysis of Variance was conducted to evaluate for statistical differences between method of evaluation and the effects of gender were controlled for. No

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40 significant differences were found based on method of evaluation in reported levels of shock anxiety, death anxiety, general anxiety, avoidance behaviors, and marital satisfaction, (Hotelling’s Trace F(5,46) = 1.308, p = .277). Overall, these groups also did not differ on demographics variables (Hotelling’s Trace F(5,46) = 2.287, p = .074). In looking at the parameter estimates, the only statistically significant difference found was that Internet method of evaluation was associated with increased history of shocks in ICD patients (t = 3.001, p =.004). Hypothesis 5 No significant differences will be found in the psychosocial measures between baseline and follow-up assessments. Findings. No ICD patients were shocked during the 6 month follow up period; therefore, no significant differences were expected. Baseline and follow up data from ICD patients and spouses were utilized in this analysis. A repeated measures MANOVA was conducted, and determined that there were no significant differences over time in reported levels of shock anxiety, death anxiety, general anxiety, avoidance behaviors, and marital satisfaction (Hotelling’s Trace F(5,21) = 1.368, p =.276). Post-Hoc Analyses The following section addresses additional interesting findings and post-hoc analyses that were conducted after the initial planned statistical analyses. Due to the addendum nature of these analyses; caution should be utilized in interpreting this data. Data regarding inter-correlations, reliability, and validity from the newly designed Shock Anxiety Survey (SAS) will be discussed. Information regarding the relationship between female ICD patients and study variables will be addressed. Results from this group about

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41 the relationship between death anxiety and shock anxiety will also be reviewed. Future research appears to be warranted in these areas with ICD patients and their spouses. Shock Anxiety Survey Two versions of the Shock Anxiety Survey (one for patients and one for spouses) were utilized to assess feelings of anxiety about ICD shocks and the associated events and thoughts. Both measures each have ten statements describing the participant’s own feelings, thoughts, and behaviors (e.g., The Patient Version, “I am afraid of being alone when the ICD fires and I need help” and the Spouse Version, “I am afraid of to leave my spouse alone because the ICD may fire and they may need help”). The participant is then asked to determine to what extent they agree with the statement on a five point Likert scale. Correlational structure, test-retest reliability, and internal consistency analyses were evaluated with each version of the SAS. Patient version. The patient version of the SAS evaluates the thoughts, feelings, and behaviors that ICD patients may engage in as a result of thoughts about or experiences with ICD shocks. Data from the 40 ICD patients that completed the patient version of the SAS were utilized in the following analyses. Inter-correlations were examined on the patient version of the SAS, and it was determined that one item will likely need to be removed when the measure is used in future research. This item states, “I am afraid to touch others for fear I’ll shock them if the ICD fires.” No patients responded that this was of any concern to them, thus this item did not correlate with the other items and should be removed from future versions. If this one item is removed then the correlational structure is excellent on the patient version of the SAS. With this item removed, the majority of items significantly correlate with each other and the total score. Lowest inter-item correlation is r = .029 (p = .861) and highest inter-item correlation is r

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42 = .822 (p =.000). Lowest item-total correlation is r = .507 (p = .001) and highest item-total correlation is r = .884 (p = .000). Table 4-12 provides complete data for internal correlations on the patient version of the SAS. Internal consistency and reliability, as measured by Cronbach’s alpha, was determined to be .921 when the item related to fear of touching others is dropped from the measure. In an attempt to determine test-retest reliability for the SAS patient version, data from the baseline and follow-up evaluations were compared. Pearson’s correlations, utilizing data from 18 patients, determined that baseline and follow-up total scores on the SAS were significantly associated (r = .780, p = .000), indicating good test-retest reliability. Death anxiety and shock anxiety were found to be significantly correlated with each other in ICD patients(r = .498, p = .001), indicating good validity when this measure is compared to other relevant variables. Spouse version. The spouse version of the SAS evaluates the thoughts, feelings, and behaviors that spouses of ICD patients may engage in as a result of thoughts about or experiences with ICD shocks. Data from 22 spouses of ICD patients were utilized in the following analyses. The correlational structure of the spouse version of the SAS was examined and it was determined that one item will likely need to be removed when the measure is used in future research. This item states, “I do not engage in sexual activities because it may cause my spouse’s ICD to fire.” This item did not correlate significantly with any other item on the spouse version of the SAS. The correlational structure is only moderate for the spouse version, which is likely due to a smaller sample size than was available in the patient version analyses. With this item removed, the majority of the items correlate well with each other and each item correlates significantly with the total score. The lowest inter-item correlation is r = .250 (p = .263) and the highest inter-item

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43 correlation is r = .770 (p = .000). Lowest item-total correlation is r = .529 (p = .011) and the highest item-total correlation is r = .833 (p = .000). Table 4-13 provides complete data for internal correlations on the spouse version of the SAS. Internal consistency and reliability as measured by Cronbach’s alpha was determined to be .853 when the item related to sexual activities is dropped from the measure. In an attempt to determine test-retest reliability for the SAS spouse version, data from the baseline and follow-up evaluations were compared. Pearson’s correlations, utilizing data from 11 spouses, determined that baseline and follow-up total scores on the SAS were significantly associated (r = .691, p = .018), indicating good test-retest reliability. Death anxiety and shock anxiety were not found to be significantly correlated in spouses, (r = .105, p = .652), indicating limited validity when this measure is compared to other relevant variables. Overall, these analyses with the SAS patient and spouse versions provide initial evidence that these measures appear to be reliable and valid measures of anxiety related to ICD shocks. These are only initial statistical analyses and further research is needed to continue to evaluate the validity and reliability of this measure in other samples of ICD patients and their spouses. Gender Differences While conducting the hypothesized analyses it became apparent that there were gender differences in the ICD patients’ reported levels of death anxiety and shock anxiety. It was determined that further analyses would be prudent to evaluate these gender differences in this group of ICD patients. Data from 31 male patients and 9

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Table 4-12. SAS patient version correlations Scaredtoexercise Being alone Do not get angry Not knowing Worry about ICD Afraid to touch Creating a scene Heart beating Unwanted thoughts Sexual activities Total score Scared to exercise 1.00 Being alone .668* .000 1.00 Do not get angry .523* .001 .779* .000 1.00 Not knowing .715* .000 .666* .000 .533* .000 1.00 Worry about ICD .476* .002 .398* .011 .294 .066 .479* .002 1.00 Afraid to touch a a a a a 1.00 Creating a scene .750* .000 .626* .000 .614* .000 .831* .000 .277 .083 a 1.00 Heart beating .680* .000 .719* .000 .603* .000 .677* .000 .273 .088 a .754* .000 1.00 Unwanted thoughts .822* .000 .738* .000 .682* .000 .606* .000 .617* .000 a .649* .000 .673* .000 1.00 Sexual activities .440* .004 .331 .051 .305 .055 .464* .003 .029 .861 a .502* .001 .326* .040 .454* .003 1.00 Total score .863* .000 .840* .000 .756* .000 .848* .000 .507* .001 a .872* .000 .820* .000 .884* .000 .579* .000 1.00 44 * Correlation is significant at the p < .05 level. a One variable is constant.

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Table 4-13. SAS spouse version correlations Scaredtoexercise Being alone Do not get angry Not knowing Worry about ICD Afraid to touch Creating a scene Heart beating Unwanted thoughts Sexual activities Total score Scared to exercise 1.00 Being alone .300 .175 1.00 Do not get angry .433* .044 .546* .009 1.00 Not knowing .355 .105 .378 .083 .321 .145 1.00 Worry about ICD .250 .263 .296 .181 .289 .192 .453* .034 1.00 Afraid to touch .335 .127 .258 .246 .586* .004 .325 .140 .409 .058 1.00 Creating a scene .435* .043 .350 .111 .412 .057 .331 .133 .573* .005 .770* .000 1.00 Heart beating .425* .049 .401 .064 .660* .001 .473* .026 .589* .004 .469* .028 .434* .044 1.00 Unwanted thoughts .690* .000 .351 .109 .523* .013 .298 .177 .491* .020 .580* .005 .686* .000 .638* .001 1.00 Sexual activities .175 .435 .323 .142 .342 .119 -.197 .380 .331 .132 .364 .096 .311 .159 .393 .070 .222 .320 1.00 Total score .625* .002 .654* .001 .760* .000 .544* .009 .695* .000 .677* .001 .700* .000 .833* .000 .756* .000 .529* .001 1.00 45 * Correlation is significant at the p < .05 level.

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46 female patients were utilized in the following analysis. A MANOVA was conducted to determine if there were indeed statistically significant differences in shock anxiety, death anxiety, and number of previous ICD shocks based on gender. The overall model was significant (Hotelling’s Trace F(3,36) = 5.794, p = .002); indicating that female ICD patients do statistically differ from male ICD patients in reported levels of shock anxiety, death anxiety, and number of previous ICD shocks. Despite the limited number of female ICD patients in this analysis, the observed effect size for the overall model was .927. The parameter estimates indicate that female ICD patients report more death anxiety, shock anxiety and previous shocks than male patients and that each variable uniquely and significantly contribute to the differences. Please see Table 14 and Table 15 for means on psychosocial measures for male and female ICD patients. As more female than male patients received shocks from their ICDs, another MANOVA was conducted to determine if there are any significant differences in medical severity in these male and female ICD patients. No significant differences between male and female patients were found in the medical indices of ejection fraction, number of cardiac diagnoses, and number of cardiac medications (Hotelling’s Trace F(3,36) = 1.126, p = .352), suggesting that medical severity was equivalent between the male and female patients in this study. The increased prevalence of death anxiety, shock anxiety, and shocks are apparently not due to the fact that the female patients have more severe heart disease. Female ICD patients in this sample appear to experience more shock anxiety, death anxiety, and shocks than male ICD patients, despite relatively equivalent medical illness severity. However, due to the small sample of female ICD patients in this analysis, caution is recommended in generalizing these results to all female ICD patients.

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47 Table 4-14. Psychosocial means for female ICD patients M SD n Min Max TOVA: Avoidance behaviors 17.56 9.17 9 4 41 MFODS: Death anxiety 27.22 8.98 9 13 38 SAS: Shock anxiety 21.56 12.25 9 10 47 STPI: General anxiety 20.33 4.50 9 14 28 DAS: Marital satisfaction 40.40 4.04 5 34 44 Table 4-15. Psychosocial means for male ICD patients M SD n Min Max TOVA: Avoidance behaviors 13.47 9.17 31 1 42 MFODS: Death anxiety 35.87 11.55 31 10 50 SAS: Shock anxiety 12.81 3.55 31 10 25 STPI: General anxiety 16.77 5.25 31 11 36 DAS: Marital satisfaction 39.00 8.80 28 5 48 Death Anxiety and Shock Anxiety Relationship Increased levels of death anxiety and shock anxiety were found to be associated with more shocks, female ICD patients and spouses of ICD patients. However, the results regarding death anxiety were statistically weaker than the results regarding shock

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48 anxiety. Two sets of hierarchical regressions were conducted to further evaluate these relationships in patients and spouses. ICD Patients. The first set of analyses utilized data from ICD patients and was conducted to evaluate the amount of variance these variables accounted for in each other when controlling for gender and previous shocks. Death anxiety and shock anxiety were found to be significantly correlated with each other (r = .498, p =.001) in ICD patients. The first regression attempted to evaluate the amount of variance that shock anxiety accounted for in death anxiety. This analysis demonstrated that gender accounted for 7.7% of unique variance, shocks accounted for an additional 3.9% of unique variance, and shock anxiety accounted for approximately 10.0% of unique variance in death anxiety. The entire corrected equation accounted for 21.6% of the variance in death anxiety [F(3,36)= 4.574, p =.008]. The second hierarchical regression evaluated the amount of unique variance that death anxiety accounted for in shock anxiety, while controlling for the effects of gender and shocks. It was found that gender accounted for 23.3%, shocks accounted for another 3.5%, and death anxiety accounted for approximately 8.2% of the variance in shock anxiety. The total corrected equation accounted for 35.0% of the variance in shock anxiety [F(3,36) = 8.008, p =.000]. Based on these two analyses, it can be concluded that death anxiety and shock anxiety are similarly associated with gender and shocks in ICD patients and both variables appear to account for a similar percentage of variance in each other. However, they appear to be two separate and distinct variables due to the moderate correlation between these two variables. This data adds unique and innovative information to the current research literature on ICD patients’ psychosocial functioning.

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49 The prevalence of shock anxiety and death anxiety in these patients and the association of these anxieties with shocks and female gender suggest that these anxieties could be significant concerns in this population. Spouses. The relationships between these same variables were explored in the spouses of ICD patients. Data from the 22 spouses were analyzed and death anxiety and shock anxiety were not found to be significantly correlated, (r = .105, p = .652). Additionally, death anxiety did not account for significant variance in shock anxiety [F(3,17) = .356, p = .786], and shock anxiety did not account for significant variance in death anxiety [F(3,17) = .466, p = .709]. It appears that the relationship between death anxiety and shock anxiety is less defined in the spouses of ICD patients. It is possible that because the spouse does not have an ICD, they do not experience the high association between shocks and fear of their own death.

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CHAPTER 5 DISCUSSION The current study provides new insights into the effects of ICDs and shocks on death and shock anxiety and the resulting psychological, marital, and behavioral adjustment in both ICD patients and their spouses. Despite the interim change in methodology due to the lack of ICD shocks in the 6 month follow-up period, this project provides innovative information on ICD patients’ and their spouses’ adjustment to the ICD. Psychosocial Frequencies Approximately 13% of ICD patients and 14% of their spouses reported an elevated fear of death, indicating that increased levels of death anxiety are present in a significant proportion of ICD patients and their spouses. This may be due to the serious cardiac disease that these patients and their spouses are attempting to manage. However, the exact cause is unknown due to the lack of current research being conducted related to death anxiety in ICD patients. ICD patients and their spouses often have to endure frequent doctor’s appointments, hospitalizations, medical procedures, and pharmaceutical interventions for their cardiac diseases and the ICD. It has been found that a moderate level of death anxiety can actually be beneficial in motivating people to remain adherent to medical regiments (Firestone, 2000; Lonetto & Templer, 1986). This literature also suggests that higher levels of death anxiety may actually interfere with medical compliance and healthy behaviors (Firestone, 2000; Lonetto & Templer, 1986). Based on the prevalence 50

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51 data in this study, some ICD patients and their spouses might be at increased risk for medical non-compliance and unhealthy behavioral patterns due to elevated death anxiety. As a result, it can also be suggested that these patients may require additional medical care and treatment to compensate for this decline in healthy behaviors. Their spouses may in turn become more demanding upon the medical treatment team due to their own fears of death and losing their loved one. Death anxiety has been found to be associated with increased social withdrawal behaviors and feelings of hopelessness and helplessness about the future, which are symptoms of depression (Firestone, 2000; Lonetto & Templer, 1986). It can be hypothesized that ICD patients and their spouses who report elevated levels of death anxiety may then be at increased risk for depression. As a result of elevated levels of death anxiety, the possibility for increased risk of depression, medical non-compliance, and reduced healthy behaviors may ultimately result in diminished quality of life for these patients and their spouses. Approximately 8% of ICD patients in this study reported elevated levels of general anxiety. In previous research addressing general anxiety in ICD patients, elevated levels ranging from 13 to 38 percent, have been found (Hegel, et al., 1997; Herrman et al., 1997; Keren, Aarons, & Veltri, 1991; Konstam, Colburn, & Butts, 1995; Luderitz, et al., 1996; Schuster, et al., 1998; Sears et al., 1999). The ICD patients in this research study appear to have a lower incidence of general anxiety than the current literature suggests. In other research, family members and spouses of ICD patients have also been found to experience elevated levels of anxiety and fear (Dougherty, 1995; Dunbar et al., 1993; Morris et al., 1991; Pycha et al., 1986; Sneed & Finch, 1992). In this project, however,

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52 no spouses of ICD patients reported elevated levels of general anxiety as compared to normative data. Previous research has found that disease specific measures appear to better predict psychosocial distress in ICD patients when compared to general measures of distress (Wallace, Sears, Lewis, Griffis, Curtis & Conti, 2002). The findings in the current study may be a result of the general anxiety measure not adequately evaluating the specific distress that ICD patients and their spouses endorse, such as was found on the shock anxiety and death anxiety measures. Although no normative data was available for comparison purposes, prevalence data on avoidance behaviors can be discussed qualitatively. It was found that ICD patients and their spouses appear to agree on the extent to which patients avoid certain behaviors, emotions, and situations. Thus, it seems that spouses are attuned to the patient’s behavioral and emotional patterns after ICD implantation. The prevalence data regarding shock anxiety indicates that this anxiety appears to affect spouses more than ICD patients. However, the spouse group is mostly females, which was found to be highly associated with shock anxiety. Based on data from this study it appears that female gender is a more potent predictor of shock anxiety than being a spouse. Due to the unexpected frequency that female gender was associated with study variables, there will be further discussion of gender differences in the post-hoc analyses section. The majority of ICD patients and their spouses in this sample reported that they are generally satisfied with their current marriages and are receiving adequate support in their relationships. Previous research has shown that spouses of cardiac patients are better able to cope with the stress associated with care-giving if they receive adequate support from

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53 their marriage (Thompson, Ersser, & Webster, 1994). Based on previous research and the high levels of marital satisfaction reported by these participants, it can be postulated that the spouses of ICD patients in this study might be better equipped to cope with the stress associated with the ICD and shocks. Further analyses will allow for better understanding of these variables in ICD patients and their spouses. The hypothesized and post-hoc analyses appear to be warranted based on the frequency data related to death anxiety and the participant group differences found in shock anxiety. Hypothesized Analyses Participant Group Differences Participant group (patient or spouse) was not a significant predictor of shock anxiety, death anxiety, and general anxiety. The variables that were controlled for (gender and previous shocks) appear to be more potent predictors of shock anxiety and death anxiety. Females (irrelevant of whether they are a spouse or patient) and those who have experienced more ICD shocks (patient or spouse) appear to be more likely to have elevated levels of shock anxiety and, to a lesser degree, death anxiety. No significant effects were found for general anxiety, which may be due to this measure’s inability to evaluate the specific distress that ICD patients and their spouses reported in this study. When gender is controlled for, these analyses also determined that spouses and ICD patients appear to be experiencing similar levels of shock anxiety and death anxiety. Since the ICD research literature to date has virtually ignored the spouses of ICD patients, this data provides new insight that spouses of ICD patients are experiencing at least as much death and shock anxiety as ICD patients. Despite the fact that the spouses do not have ICDs, they appear to be equally distressed by thoughts of ICD shocks and

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54 concerns related to death and the dying process. Current research suggests that spouses of ICD patients appear to be significantly concerned with the health of the patient and that caring for the patient was their most important concern (Dougherty, Pyper, & Benoliel, 2004). This study provides further evidence that spouses consider the patient’s illness to be a part of the family system, as a type of collective health condition that the couple manages as a team. This idea of a collective health condition puts patients and spouses at an apparent equal risk for developing anxiety related to the device and shocks. Future research and clinical interventions focused on ICD patients and their spouses should begin to address the elevated levels of death anxiety and shock anxiety that are reported in these groups, especially in those who have experienced shocks. Based on the findings of this research that patients and spouses report anxiety and cognitive distortions specifically related to the ICD and its shocks, it appears that cognitive-behavioral techniques could be helpful to those who are coping with ICD specific concerns. Avoidance Behaviors Shock anxiety was found to significantly predict avoidance behaviors in ICD patients. History of shocks, general anxiety, and death anxiety were not significant predictors of avoidance behaviors in ICD patients. This finding demonstrates that the cognitive thought patterns or fears of shocks are more predictive of avoidance behaviors in ICD patients than history of ICD shocks. This interesting finding is supported in other recent research that suggests that the cognitive aspects of ICD shocks are in fact more important than the actual shocks at predicting avoidance behaviors (Lemon, Edelman, & Kirkness, 2004). Data from the current study suggests that even ICD patients who have never received shocks, or those who have not had a shock for some time, are at risk for

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55 increased avoidance behaviors. Previously, patients who received ICD shocks were thought to be the group at significantly higher risk for avoidance behaviors (Heller et al., 1998, Sears et al., 1999). This current research and other recent research suggest that all ICD patients could experience feelings of shock anxiety and resultant avoidance behaviors regardless of shock exposure. It is also recommended that patients who express anxiety about ICD shocks be evaluated for unhealthy behavior and thought patterns that may result in reduced quality of life. If shock anxiety is identified, the patient may benefit from learning appropriate coping skills, education about the ICD, and support to minimize the possibility of developing harmful avoidance behavior patterns resulting in reduced quality of life. Controlled research designs are needed to further understand and explain the relationships between shocks, cognitions, and avoidance behaviors in ICD patients. Effects of Shocks Previous ICD shocks were not found to be associated with increased general anxiety and marital dysfunction. History of ICD shocks and gender were found to significantly predict shock anxiety, and to a lesser degree, death anxiety. These findings demonstrate that history of ICD shocks appears to be important in determining levels of shock anxiety and death anxiety and that female gender appears to be even more indicative of increased levels of shock anxiety and death anxiety. One of the recurring themes in the psychosocial ICD literature is that increasing number of ICD shocks leads to increasing anxiety symptoms in ICD patients and their loved ones (Morris et al., 1991; Sears et al., 1999; Kohn et al., 2000; Sears & Conti, 2002). This finding appears to have been replicated in this current study. However, the results regarding female genders association with increased shock anxiety have never before been demonstrated.

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56 While other research has found that ICD shocks result in increased general anxiety or device specific anxiety in patients and spouses (Morris et al., 1991; Sears et al., 1999; Kohn et al., 2000; Sears & Conti, 2002), this study is the first to determine that shocks are also associated with increased death anxiety. Again, given the prevalence of death anxiety in this population and the increased risk of death anxiety related to shocks and female gender, it appears that this is a significant concern for this population. Clinical interventions focused on the specific fears related to death reported in this study, such as fears of the unknown, fears of pain, and fears dying early, will likely benefit these patients and their spouses. Emphasizing the importance of quality of life may be important in these patients and spouses, particularly if they begin to limit their activities and social interactions due to fears of shocks and death. Utilizing and developing strong marital relationships would likely minimize this death anxiety and improve their “couple’s coping” ability. Method of Evaluation Differences Approximately 29% of the participants that were offered an option, chose to utilize the Internet-based evaluation method. Seventeen of the participants were not provided with the option to utilize the Internet methodology in an attempt to ensure adequate sample size. It is possible that the majority of participants chose not to utilize the internet due to lack of access or lack of understanding of computers, as only 20% of people aged 65 and older have home Internet access (U.S. Census Bureau, Current Population Survey, August 2000). Despite the limited home Internet access in this population, an analysis determined that there were no significant differences between the participants who chose Internet over paper on any of the psychosocial or demographic variables. The only difference

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57 between the methods of evaluation appears to be that the participants who utilized the Internet evaluation received more shocks than those who chose the paper evaluation. It can be concluded, based on this data, that Internet based psychosocial evaluations in this population appear to be an adequate, valid, and accepted method of conducting research. With the increasing number of people who have access to the Internet at home and at work, it is likely that this form of data collection will become more accepted and more utilized throughout all areas of research (Erdman, 1985; Pew Internet, 2000). As researchers attempt to develop innovative and more accessible methods of collecting data, utilizing the Internet as a research tool appears to be an excellent option for participants and researchers. Changes over Time A revision was made to the proposed methodology because no ICD patients in this study received shocks within the 6 month follow-up period. It is possible that no ICD patients were shocked due to an overall decrease in the incidence of ICD shocks because (1) more ICDs are now implanted and utilized for prophylaxis rather than primary treatment of VT or VF, (2) improved programming algorithms are currently utilized to manage cardiac arrhythmias, (3) tiered electrical treatments provided by the ICD, and (4) improved pharmacological management of arrhythmias. All of these developments in technology and knowledge may have resulted in reduced ICD shocks during the 6 month follow-up period. As was expected due tot the change in methodology, there were no changes in any of the psychosocial variables in ICD patients and their spouses over the 6-month follow-up period.

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58 Shock Anxiety Survey In previous research it has been determined that disease specific measures are better able to describe and predict psychosocial distress in ICD patients (Wallace, et al., 2002). The Shock Anxiety Survey (SAS) was developed for this project because there were no available questionnaires to address this concept in ICD patients and their spouses. The SAS has a version for ICD patients and a version for spouses. The patient version was found to have good internal correlation structure, good test-retest reliability, and good internal reliability as measured by Cronbach’s alpha. The spouse version was found to have moderate internal correlational structure, good test-retest reliability, and good internal reliability. It was determined that both versions would have better correlational and factor structure if one item was dropped from each version. Future research will be required with the remaining 9 items to further evaluate the factor structure of these measures. A complete factor analysis was not conducted on the SAS because there were not a sufficient number of participants to provide adequate power for that analysis. Gender Differences One of the unexpected findings in this study regarding ICD patients was the importance of gender. Female ICD patients had more previous ICD shocks, experienced more shock anxiety, and more death anxiety than male ICD patients. Moreover, the indicators of cardiac illness were found to be equivalent across genders, suggesting that males and females in this study are at relatively equivalent risk of shocks and death. These preliminary findings contribute to the current literature on ICD patients because there is so little research describing the psychological functioning of female ICD patients. Recent literature has postulated that female ICD patients may be at increased risk for psychological distress, but until now there has been little research addressing this

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59 possibility (Walker, Campbell, Sears, Glenn, Sotile, Curtis & Conti, 2004). This increased risk is in part because females report clinically significant symptoms of anxiety at nearly twice the frequency of men in epidemiologic studies (American Psychological Association, 1996). Women have also been found to be more sensitive to the effects of physical scars and physical changes due to society’s emphasis on female physical attractiveness (Lawrence, Fauerbach, Heinberg, & Doctor, 2004). Women are now increasingly more likely to receive an ICD as the indications for implantation have grown over recent years (Wolbrette et al., 2002). It has also been consistently found that in the general population, women report higher levels of death anxiety (Schulz, 1979). The combination of more women receiving ICDs and the possibility of women being at increased risk for psychological distress creates a complicated situation for healthcare professionals working with female ICD patients. It appears that female ICD patients may need to be screened early to evaluate for any anxiety related to their cardiac illness, the ICD, and shocks. Psychological interventions that will be of most assistance to female ICD patients include education about the ICD, coping skills training, and supportive therapy focused on the specific needs of female ICD patients, including social support, body image concerns, and other age specific concerns (Walker et al., 2004). Women tend to turn to their social support system in times of stress (Taylor, Klein, Lewis, Gruenewald, Gurung, & Updegraff, 2000). This is a healthy response and should be encouraged for female ICD patients. Perhaps support groups focused on issues related to female ICD patients would benefit these patients by providing peer group support.

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60 Future research should investigate the factors that contribute to women’s apparent tendency to report elevated levels of death anxiety and shock anxiety. Through future research, protective measures need be identified and then invoked to inoculate female ICD patients from elevated levels of anxiety. Death Anxiety and Shock Anxiety Relationship Death anxiety and shock anxiety accounted for a significant amount of variance in each other, but moderate correlations indicate that they measure separate entities. Many of these patients and their spouses have experienced “near death” and then returned to life by medical science. While the ICD has repeatedly been proven as a life saving device, some of these patients and their spouses appear to have significant anxiety related to the device and fears of death (Pauli, Wiedemann, Dengler, Balumann-Benninghoff, & Kuhlkamp, 1999). These variables appear to be particularly relevant to this population of cardiac patients and their spouses, which may be due to the nature of the ICD and the severity of the underlying cardiac disease. These variables should continue to be measured in future research due the prevalence of these anxieties in this population and because of their apparent relevance to patients’ and spouses’ psychosocial functioning and quality of life. Limitations There are some limitations that should be kept in mind in the interpretation of these results. First, this study was limited in the number of patients and spouses participating in data collection. This limitation may have resulted in reduced significant findings regarding the stated hypotheses due to reduced statistical power. Additional participants were recruited to increase the sample size once the change in methodology became

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61 apparent. Special consideration was given to the power and type of the analyses and Bonferroni corrections were applied in multiple analyses to control for Type I errors. Second, the study only recruited participants from one medical center, which may have produced a biased sample. Analyses evaluating this sample found the participants to be relatively equivalent to the national population of ICD patients in regards to demographic variables. Additionally, this medical center serves a wide geographical area, thus controlling for some possible site effects. Third, self-report measures are sometimes influenced by demand patient characteristics, which is how a participant perceives they should respond or how they would like themselves to be perceived. This is always a consideration when using self-report measures, and the researchers attempted to correct for this by allowing the participants to complete the questionnaires in privacy in the cardiac outpatient clinic or in their own home and by assuring confidentiality of responses after data collection. Fourth, indications for ICD implantation were not controlled in this study. Since this project began, new research has suggested that a greater variety of cardiac diseases may benefit from the ICD, thus creating a more diverse group of patients. Some attempt was made to control for this by including the cardiac diagnoses, ejection fraction, and prescribed cardiac medications in the relevant analyses. Finally, because no ICD patients were shocked in the 6 month follow-up period, data regarding the immediate effects of these shocks was not obtained in this study. While this was unexpected and uncontrollable, this resulted in an inability to evaluate the changes over time caused by ICD shocks. However, the researchers were able to utilize

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62 data regarding previous shocks in the analyses to evaluate the effects of historical ICD shocks. Conclusions Given these considerations, this study offers new information regarding the effects of ICDs and shocks on death and shock anxiety and the resulting psychological, marital, and behavioral adjustment in both ICD patients and their spouses. In this project, it was found that patients and spouses reported similar levels of shock anxiety, death anxiety, general anxiety, and martial satisfaction. Shock anxiety was determined to be a significant predictor of avoidance behaviors in ICD patients, above and beyond shocks. ICD shocks were found to be associated with increased levels of shock anxiety and, to a lesser extent, with death anxiety in patients and spouses. Analyses evaluating Internet based evaluations as compared to paper based evaluations, determined that there are no significant differences in the amount or type of psychosocial information revealed by ICD patients and their spouses. Finally, because no patients were shocked within the 6 month interim follow-up period, an analysis was conducted and demonstrated that there were no significant differences between baseline and follow-up on any of the psychosocial measures. Post-hoc analyses were conducted to further investigate interesting findings that surfaced during the hypothesized analyses. Female ICD patients reported increased risk of death anxiety, shock anxiety, and received more shocks, despite equivalent indices of medical severity. The validity and reliability of the Shock Anxiety Scale was initially evaluated in this study and was found to be an accurate and reliable measure of feelings of anxiety related to ICD shocks in patients and spouses. Finally, death anxiety and

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63 shock anxiety were found to be associated with each other, female gender, and previous shocks. In closing, the findings from this study suggest that ICD patients and their spouses who report elevated feelings of death and shock anxiety should be evaluated for psychological intervention to minimize adjustment difficulties and possible declines in quality of life after ICD implantation. Particular groups that appear to be at some increased risk for these anxieties and adjustment difficulties include female patients who have received shocks and female spouses.

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APPENDIX A PATIENT QUESTIONNAIRES Table A-1. Patient questionnaires Before you complete this questionnaire, please review the following list of levels of physical activity. Eight levels are shown with examples given in each category. 1 Sleeping/ Reclining Sunbathing, lying on couch, watching TV 2 Sitting Eating, reading, deskwork, watching TV, highway driving 3 Very Light Exertion Office work, city driving, personal care, standing in line, strolling in park 4 Light exertion, normal breathing Mopping, slow walking, bowling, sweeping, golfing with a cart, gardening with power tools 5 Moderate exertion, deep breathing Normal walking, golfing on foot, slow biking, downhill skiing, raking leaves, cleaning windows, interior painting, slow dancing, light restaurant work 6 Vigorous exertion, panting; overheating Slow jogging, tennis, swimming, x-country skiing, shoveling snow, fast biking, mowing with a push mower, heavy gardening, climbing up/down ladder, softball, laying bricks, hurried heavy restaurant work 7 Heavy exertion, gasping; much sweating Running, fast jogging, pushing a car in snow, changing tires, shoveling heavy snow, competitive basketball, putting down carpet, ladder or stair climbing with 50 lb. load 8 Extreme or peak exertion Sprinting, fast running, fast jogging or jogging uphill, pushing and pulling with all your might, unusually extreme work Since implantation, or in the past 6 months, on average how often do you participate in activities that correspond to the following levels: 1. To the level of number 5 on the scale, moderate exertion: Daily Weekly Monthly Yearly 2. To the level of number 6 on the scale, vigorous exertion: Daily Weekly Monthly Yearly 3. To the level of number 7 on the scale, heavy exertion: Daily Weekly Monthly Yearly 64

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65 4. To the level of number 8 on the scale, extreme exertion: Daily Weekly Monthly Yearly 5. On average how often do you have sexual intercourse? Daily Weekly Monthly Yearly Before you fill out this section, please review the following seven levels of anger which people experience. 1 Calm 2 Busy, but not hassled 3 Mildly angry, irritated and hassled But it does not show 4 Moderately angry So hassled that it shows in your voice 5 Very angry Body tense, clenching of fists or teeth 6 Furious Almost out of control, very angry, pounding table, slamming door 7 Enraged Lost control, throw objects, hurting yourself or others Since implantation, or in the past 6 months, on average how often do you experience the feelings that correspond to the following levels: 6. To the level of number 4 on the scale, moderately angry: Daily Weekly Monthly Yearly 7. To the level of number 5 on the scale, very angry: Daily Weekly Monthly Yearly 8. To the level of number 6 on the scale, furious: Daily Weekly Monthly Yearly 9. To the level of number 7 on the scale, enraged: Daily Weekly Monthly Yearly Before you fill out this section please review the following levels of anxiety which people experience. 1 Mildly tense Worried or pre-occupied 2 Moderately tense Restless, keyed up, upset 3 Very tense Worries interfering with sleep or concentration 4 Extremely tense Fear or panic, periods of shaking, dizziness or intense distress

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66 Since implantation, or in the past 6 months, on average how often do you experience the feelings that correspond to the following levels: 10. To the level number 2 on the scale, moderately tense: Daily Weekly Monthly Yearly 11. To the level number 3 on the scale, very tense: Daily Weekly Monthly Yearly 12. To the level number 4 on the scale, extremely tense: Daily Weekly Monthly Yearly Most persons have disagreements in their relationships. Please indicate below the approximate extent of agreement/disagreement between you and your partner for each item on the following list. All the time Most of the time More often than not Occasionally Rare ly Never How often do you discuss or have you considered divorce, separation, or terminating your relationship? How often do you or your mate leave the house after a fight? In general, how often do you think that things between you and your partner are going well? Do you confide in your mate? Do you ever regret that you married (or lived together)? How often do you and your partner quarrel? How often do you and your mate “get on each other’s nerves?” Every day Almost every day Occasionally Rarely Never Do you kiss your mate?

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67 The dots on the following line represent different degrees of happiness in your relationship. The middle point, “happy,” represents the degree of happiness of most relationships. Please circle the dot that best describes the degree of happiness, all things considered, of your relationship. • • • • • • • Extremely Fairly A little Happy Very Extremely Perfect Unhappy Unhappy Unhappy Happy Happy Which of the following statements best describes how you feel about the nature of your relationship. I want desperately for my relationship to succeed, and would go to almost any length to see that it does. I want very much for my relationship to succeed, and will do all that I can to see that it does. I want very much for my relationship to succeed, and will do my fair share to see that it does. It would be nice if my relationship succeeded, but I can’t do much more than I am doing now to help it succeed. It would be nice if it succeeded, but I refuse to do any more than I am doing now to keep the relationship going. My relationship can never succeed, and there is no more that I can do to keep the relationship going. Listed below are death-related events and circumstances that some people find to be fear-evoking. Indicate the extent to which you agree or disagree with each statement by circling one answer for each item. Do not skip any items is you can avoid it. 1= Strongly Agree 2= Mildly Agree 3= Neither Agree nor Disagree 4= Mildly Disagree 5= Strongly Disagree I am afraid of dying very slowly 2 3 4 5 I have a fear of not accomplishing my goals in life before dying. 1 2 3 4 5 I am afraid I will not live long enough to enjoy my retirement 1 2 3 4 5 I am afraid of dying in a fire. 1 2 3 4 5

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68 I am afraid I will not have time to experience everything I want to. 1 2 3 4 5 I am afraid of experiencing a great deal of pain when I die. 1 2 3 4 5 I am afraid of dying of cancer... 1 2 3 4 5 I have a fear of suffocating (including drowning).1 2 3 4 5 I am afraid I may never see my children grow up. 1 2 3 4 5 I have a fear of dying violently..1 2 3 4 5 I am scared to exercise because it may increase my heart rate and cause my device to fire. 1 2 3 4 5 Not at all Rarely Some of the time Most of the time All the time I am afraid of being alone when the ICD fires and I need help. 1 2 3 4 5 Not at all Rarely Some of the time Most of the time All the time I do not get angry or upset because it may cause my ICD to fire. 1 2 3 4 5 Not at all Rarely Some of the time Most of the time All the time It bothers me that I do not know when the ICD will fire. 1 2 3 4 5 Not at all Rarely Some of the time Most of the time All the time I worry about the ICD not firing sometime when it should. 1 2 3 4 5 Not at all Rarely Some of the time Most of the time All the time I am afraid to touch others for fear I’ll shock them if the ICD fires. 1 2 3 4 5 Not at all Rarely Some of the time Most of the time All the time I worry about the ICD firing and creating a scene. 1 2 3 4 5 Not at all Rarely Some of the time Most of the time All the time When I notice my heart beating rapidly, I worry that the ICD will fire. 1 2 3 4 5 Not at all Rarely Some of the time Most of the time All the time I have unwanted thoughts of my ICD firing. 1 2 3 4 5 Not at all Rarely Some of the time Most of the time All the time I do not engage in sexual activities because it may cause my ICD to fire. 1 2 3 4 5

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69 Not at all Rarely Some of the time Most of the time All the time Read each statement and then indicate how you generally feel. Please circle the answer which seems to best describe your feelings. 1 = Almost Never 2 = Sometimes 3 = Often 4 = Almost Always I am a steady person. 1 2 3 4 I feel satisfied with myself 2 3 4 I get in a state of tension or turmoil as I think over my recent concerns and interests 2 3 4 I wish I could be as happy as others seem to be 2 3 4 I feel like a failure 1 2 3 4 I feel nervous and restless 1 2 3 4 I feel secure.. 1 2 3 4 I lack self-confidence 2 3 4 I feel inadequate 2 3 4 I worry too much over something that really does not matter. 1 2 3 4

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APPENDIX B SPOUSE QUESTIONNAIRES Table B-1. Spouse questionnaires Before you complete this questionnaire, please review the following list of levels of physical activity. Eight levels are shown with examples given in each category. 1 Sleeping/ Reclining Sunbathing, lying on couch, watching TV 2 Sitting Eating, reading, deskwork, watching TV, highway driving 3 Very Light Exertion Office work, city driving, personal care, standing in line, strolling in park 4 Light exertion, normal breathing Mopping, slow walking, bowling, sweeping, golfing with a cart, gardening with power tools 5 Moderate exertion, deep breathing Normal walking, golfing on foot, slow biking, downhill skiing, raking leaves, cleaning windows, interior painting, slow dancing, light restaurant work 6 Vigorous exertion, panting; overheating Slow jogging, tennis, swimming, x-country skiing, shoveling snow, fast biking, mowing with a push mower, heavy gardening, climbing up/down ladder, softball, laying bricks, hurried heavy restaurant work 7 Heavy exertion, gasping; much sweating Running, fast jogging, pushing a car in snow, changing tires, shoveling heavy snow, competitive basketball, putting down carpet, ladder or stair climbing with 50 lb. load 8 Extreme or peak exertion Sprinting, fast running, fast jogging or jogging uphill, pushing and pulling with all your might, unusually extreme work Since implantation, or in the past 6 months, on average how often does your spouse participate in activities that correspond to the following levels: 1. To the level of number 5 on the scale, moderate exertion: Daily Weekly Monthly Yearly 2. To the level of number 6 on the scale, vigorous exertion: Daily Weekly Monthly Yearly 3. To the level of number 7 on the scale, heavy exertion: Daily Weekly Monthly Yearly 70

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71 4. To the level of number 8 on the scale, extreme exertion: Daily Weekly Monthly Yearly 5. On average how often do you have sexual intercourse? Daily Weekly Monthly Yearly Before you fill out this section, please review the following seven levels of anger which people experience. 1 Calm 2 Busy, but not hassled 3 Mildly angry, irritated and hassled But it does not show 4 Moderately angry So hassled that it shows in your voice 5 Very angry Body tense, clenching of fists or teeth 6 Furious Almost out of control, very angry, pounding table, slamming door 7 Enraged Lost control, throw objects, hurting yourself or others Since implantation, or in the past 6 months, on average how often does your spouse experience the feelings that correspond to the following levels: 6. To the level of number 4 on the scale, moderately angry: Daily Weekly Monthly Yearly 7. To the level of number 5 on the scale, very angry: Daily Weekly Monthly Yearly 8. To the level of number 6 on the scale, furious: Daily Weekly Monthly Yearly 9. To the level of number 7 on the scale, enraged: Daily Weekly Monthly Yearly Before you fill out this section please review the following levels of anxiety which people experience. 1 Mildly tense Worried or pre-occupied 2 Moderately tense Restless, keyed up, upset 3 Very tense Worries interfering with sleep or concentration 4 Extremely tense Fear or panic, periods of shaking, dizziness or intense distress

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72 Since implantation, or in the past 6 months, on average how often does your spouse experience the feelings that correspond to the following levels: 10. To the level number 2 on the scale, moderately tense: Daily Weekly Monthly Yearly 11. To the level number 3 on the scale, very tense: Daily Weekly Monthly Yearly 12. To the level number 4 on the scale, extremely tense: Daily Weekly Monthly Yearly Most persons have disagreements in their relationships. Please indicate below the approximate extent of agreement/disagreement between you and your partner for each item on the following list. All the Time Most of the time More often than not Occasionally Rare ly Never How often do you discuss or have you considered divorce, separation, or terminating your relationship? How often do you or your mate leave the house after a fight? In general, how often do you think that things between you and your partner are going well? Do you confide in your mate? Do you ever regret that you married (or lived together)? How often do you and your partner quarrel? How often do you and your mate “get on each other’s nerves?” Every day Almost every day Occasionally Rarely Never Do you kiss your mate? The dots on the following line represent different degrees of happiness in your relationship. The middle point, “happy,” represents the degree of happiness of most

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73 relationships. Please circle the dot that best describes the degree of happiness, all things considered, of your relationship. • • • • • • • Extremely Fairly A little Happy Very Extremely Perfect Unhappy Unhappy Unhappy Happy Happy 10. Which of the following statements best describes how you feel about the nature of your relationship? I want desperately for my relationship to succeed, and would go to almost any length to see that it does. I want very much for my relationship to succeed, and will do all that I can to see that it does. I want very much for my relationship to succeed, and will do my fair share to see that it does. It would be nice if my relationship succeeded, but I can’t do much more than I am doing now to help it succeed. It would be nice if it succeeded, but I refuse to do any more than I am doing now to keep the relationship going. My relationship can never succeed, and there is no more that I can do to keep the relationship going. Listed below are death-related events and circumstances that some people find to be fear-evoking. Indicate the extent to which you agree or disagree with each statement by circling one answer for each item. Do not skip any items is you can avoid it. 1= Strongly Agree 2= Mildly Agree 3= Neither Agree nor Disagree 4= Mildly Disagree 5= Strongly Disagree I am afraid of dying very slowly 1 2 3 4 5 I have a fear of not accomplishing my goals in life before dying.. 1 2 3 4 5 I am afraid I will not live long enough to enjoy my retirement. 1 2 3 4 5 I am afraid of dying in a fire.. 1 2 3 4 5

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74 I am afraid I will not have time to experience everything I want to.. 1 2 3 4 5 I am afraid of experiencing a great deal of pain when I die.. 1 2 3 4 5 I am afraid of dying of cancer 1 2 3 4 5 I have a fear of suffocating (including drowning)..1 2 3 4 5 I am afraid I may never see my children grow up..1 2 3 4 5 I have a fear of dying violently.. 1 2 3 4 5 I am scared to let my spouse exercise because it may increase their heart rate and cause their ICD to fire. 1 2 3 4 5 Not at all Rarely Some of the time Most of the time All the time I am afraid of to leave my spouse alone because the ICD may fire and they may need help. 1 2 3 4 5 Not at all Rarely Some of the time Most of the time All the time I do not get angry or upset with my spouse because it may cause their ICD to fire. 1 2 3 4 5 Not at all Rarely Some of the time Most of the time All the time It bothers me that I do not know when the ICD will fire. 1 2 3 4 5 Not at all Rarely Some of the time Most of the time All the time I worry about the ICD not firing sometime when it should. 1 2 3 4 5 Not at all Rarely Some of the time Most of the time All the time I am afraid to touch my spouse for fear they will shock me if the ICD fires. 1 2 3 4 5 Not at all Rarely Some of the time Most of the time All the time I worry about the ICD firing and creating a scene. 1 2 3 4 5 Not at all Rarely Some of the time Most of the time All the time When I think my spouse’s heart is beating rapidly, I worry that the ICD will fire. 1 2 3 4 5 Not at all Rarely Some of the time Most of the time All the time I have unwanted thoughts of the ICD firing. 1 2 3 4 5

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75 Not at all Rarely Some of the time Most of the time All the time I do not engage in sexual activities because it may cause my spouse’s ICD to fire. 1 2 3 4 5 Not at all Rarely Some of the time Most of the time All the time Read each statement and then indicate how you generally feel. Please circle the answer which seems to best describe your feelings. 1 = Almost Never 2 = Sometimes 3 = Often 4 = Almost Always I am a steady person....1 2 3 4 I feel satisfied with myself.. 2 3 4 I get in a state of tension or turmoil as I think over my recent concerns and interests..1 2 3 4 I wish I could be as happy as others seem to be.........1 2 3 4 I feel like a failure.. 1 2 3 4 I feel nervous and restless...1 2 3 4 I feel secure.1 2 3 4 I lack self-confidence..1 2 3 4 I feel inadequate..1 2 3 4 I worry too much over something that really does not matter 2 3 4

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77 Credner, S.C., Klingenheben, T., Mauss, O., Sticherling, C., & Hohnloser, S.H. (1998). Electrical storm in patients with transvenous implantable cardioverter-defibrillators: incidence, management and prognostic implications. Journal of the American College of Cardiology, 32 (7), 1909-1915. Dougherty, C.M. (1995). Psychosocial reactions and family adjustment in shock versus no shock groups after implantation of internal cardioverter defibrillator. Heart and Lung, 24, 281-291. Dougherty, C.M., Pyper, G.P., & Benoliel, J.Q. (2004). Domains of concern of intimate partners of sudden cardiac arrest survivors after ICD implantation. Journal of Cardiovascular Nursing, 19 (2), 21-31. Dunbar, S.B., Warner, C. D., & Purcell, J. A. (1993). Internal cardioverter defibrillator device discharge: Experiences of patients and family members. Heart and Lung, 22, 494-501. Erdman, H.P., Klein, M.H., Greist, J.H. (1985). Direct patient computer interviewing. Journal of Consulting and Clinical Psychology, 53 (6), 760-773. Firestone, R.W. (2000). Microsuicide and the elderly: A basic defense against death anxiety. In A. Tomer (Ed.) Death Attitudes and the Older Adult, (pp. 65-84) Philadelphia, PA: Brunner-Routledge Publishing. Godeman, F., Butter, C., Lampe, F., Linden, M., Schlegl, M., Schultheiss, H., & Behrens, S. (2004). Panic disorders and agoraphobia: Side effects of treatment with an implantable cardioverter/defibrillator. Clinical Cardiology, 12, 321-326. Greist, J.H., Gustafson, D.F., Strauss, F.F., Rowse, G.L., Laughren, T.P., & Chiles, J.A. (1973). A computer interview for suicide-risk prediction. American Journal of Psychiatry, 130 (12), 1327-1332. Greist, J.H., Klein, M.H., Erdman, H.P., & Jefferson, J.W. (1983). Clinical computer applications in mental health. Journal of Medical Systems, 7 (2), 175-185. Hegel, M.T., Griegel, L.E., Black, C., Goulden, L., & Ozahowski, T. (1997). Anxiety and depression in patients receiving implanted cardioverter-defibrillators: A longitudinal investigation. International Journal of Psychiatry in Medicine, 27, 57-69. Heller, S.S., Ormont, M. A., Lidagoster, L., Sciacca, R.R., & Steinberg, J. S. (1998). Psychosocial outcome after ICD implantation: A current perspective. Pacing and Clinical Electrophysiology, 21, 1207-1215. Herrman, C., von zur Muhen, F., Schaumann, A., Buss, U., Kemper, S., Wantzen, C., & Gonska, B. (1997). Standardized assessment of psychological well-being and

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78 quality-of-life in patients with implanted defibrillators. Pacing and Clinical Electrophysiology, 20, 95-103. Hilbert, G.A. (1996). Cardiac couples at hospitalization and 3 months later. Journal of Family Nursing, 2 (1), 76-91. Irvine, J., Dorian, P., Baker, B., O’Brien, B.J., Roberts, R., Gent, M., Newman, D., & Connolly, S. (2002). Quality of life in the Canadian Implantable Defibrillator Study (CIDS). American Heart Journal, 144 (2), 282-289. Jones, J.L. (1994). Ventricular fibrillation. In I. Singer (Ed.), Implantable cardioverter defibrillator (pp. 43-67). Armonk, NY: Future Publishing. Kastenbaum, R. (2000). The Psychology of Death. New York, NY: Springer Publishing Company. Keren, R., Aarons, D., & Veltri, E.P. (1991). Anxiety and depression in patients with life threatening ventricular arrhythmias: Impact of the implantable cardioverter defibrillator. Pacing and Clinical Electrophysiology, 14, 181-187. Kohn, C.S., Petrucci, R.J., Baessler, C., Soto, D.M., & Movsovitz, C. (2000). The effect of psychological intervention on patients’ long term adjustment to the ICD: A prospective study. Pacing and Clinical Electrophysiology, 23, 450-456. Konstam, V., Colburn, C., & Butts, L. (1995). Psychosocial adaptation of automatic implantable cardioverter defibrillator recipients–Implications for the rehabilitation counselor. Journal of Applied Rehabilitation Counseling, 26, 19-22. Kop, W.J., Krantz, D.S., Nearing, B.D., Gottdiener, J.S., Quigley, J.F., O’Callahan, M., DelNegro, A.A., Friehling, T.D., Karasik, P., Suchday, S., Levine, J., & Verrier, R.L. (2004). Effects of acute mental stress and exercise on T-wave alternans in patients with implantable cardioverter defibrillators and controls. Circulation, 109, 1864-1869. Kubler-Ross, E. (1996). On Death and Dying . Collier Books, New York, NY: Macmillan Publishing Company. Lampert, R., Jain, D., Burg, M.M., Batsford, W.P., & McPherson, C.A. (2000). Destabilizing effects of mental stress on ventricular arrhythmias in patients with implantable cardioverter defibrillators. Circulation, 101, 158-164. Lawrence, J.W., Fauerbach, J.A., Heinberg, L., & Doctor, M. (2004). Visible vs hidden scars and their relation to body esteem. Journal of Burn Care and Rehabilitation, 25 (1), 25-32.

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BIOGRAPHICAL SKETCH Robyn L. Walker was born in Coral Springs, Florida, on September 26th, 1976 to Craig and Cathie Wallace. Her brother, Tye, is 3 years younger and is currently engaged to be married to a wonderful woman, Catherine. Robyn married Stephen E. Walker on May 4th, 2002 and they currently reside in St. Petersburg, Florida. She received her Bachelor of Science degree with highest honors in psychology, from the University of Florida, in May of 1999. She also received her Master of Science degree in clinical psychology from the University of Florida, in May of 2001. Robyn enjoys spending time with her family, friends, and her husband. She also enjoys walking and playing with her three dogs; Bear, Roxie, and Katie. She is currently working as a post-doctoral associate at the James A. Haley VA Medical Center in Tampa, Florida. Her future career goals include combining research and clinical work in behavioral medicine in Florida. 82