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Female-Specific Education, Management, and Lifestyle Enhancement for Implantable Cardioverter Defibrillator Patients

Permanent Link: http://ufdc.ufl.edu/UFE0022830/00001

Material Information

Title: Female-Specific Education, Management, and Lifestyle Enhancement for Implantable Cardioverter Defibrillator Patients The FEMALE-ICD Study
Physical Description: 1 online resource (59 p.)
Language: english
Creator: Vazquez, Lauren
Publisher: University of Florida
Place of Publication: Gainesville, Fla.
Publication Date: 2009

Subjects

Subjects / Keywords: cardiology, icd, intervention, psychological, quality, women
Clinical and Health Psychology -- Dissertations, Academic -- UF
Genre: Psychology thesis, Ph.D.
bibliography   ( marcgt )
theses   ( marcgt )
government publication (state, provincial, terriorial, dependent)   ( marcgt )
born-digital   ( sobekcm )
Electronic Thesis or Dissertation

Notes

Abstract: Significant rates of psychological distress occur in implantable cardioverter defibrillator (ICD) patients. Research has demonstrated that women are a particularly at-risk group for developing psychological distress secondary to cardiac disease. The major objectives of the current study were to implement and test the effectiveness of a psychosocial group intervention in outpatient female ICD recipients vs. a wait list control group. Twenty-nine female ICD patients were recruited from Shands Hospital at the University of Florida. Fourteen women were randomized to the intervention group and 15 the wait list control group. All women completed individual psychological batteries at baseline and at one-month follow-up measuring shock anxiety, death anxiety, body image concerns, and sexual dysfunction. Pre-post measures of shock anxiety demonstrated a significant time by group interaction effect with the intervention group having a significantly greater decrease in anxiety (Pillai?s trace = 5.58, p = .03) than the control participants. A significant interaction effect (Pillai?s trace = 5.05, p = .046) was found, such that women under the age of 50 experienced greater reduction in shock anxiety, than their middle-aged cohorts. Pre-post measures of device acceptance revealed a significant time by group interaction effect with the intervention group having significantly greater increases in reported device acceptance (Pillai?s trace = 5.80, p = .02) than the control participants. Young women reported greater increased in device acceptance than both the middle- and older-aged groups, and women between the ages of 51 and 64 reported higher rates of device acceptance increase than women over 65. This study indicates that structured interventions for female ICD patients involving ICD-specific education, CBT strategies, and group social support can provide improvements in shock anxiety and device acceptance. Young women appear to be an at-risk subgroup of this population and would benefit from psychosocial treatment targeting device-specific concerns.
General Note: In the series University of Florida Digital Collections.
General Note: Includes vita.
Bibliography: Includes bibliographical references.
Source of Description: Description based on online resource; title from PDF title page.
Source of Description: This bibliographic record is available under the Creative Commons CC0 public domain dedication. The University of Florida Libraries, as creator of this bibliographic record, has waived all rights to it worldwide under copyright law, including all related and neighboring rights, to the extent allowed by law.
Statement of Responsibility: by Lauren Vazquez.
Thesis: Thesis (Ph.D.)--University of Florida, 2009.
Local: Adviser: Sears, Samuel F.
Electronic Access: RESTRICTED TO UF STUDENTS, STAFF, FACULTY, AND ON-CAMPUS USE UNTIL 2011-08-31

Record Information

Source Institution: UFRGP
Rights Management: Applicable rights reserved.
Classification: lcc - LD1780 2009
System ID: UFE0022830:00001

Permanent Link: http://ufdc.ufl.edu/UFE0022830/00001

Material Information

Title: Female-Specific Education, Management, and Lifestyle Enhancement for Implantable Cardioverter Defibrillator Patients The FEMALE-ICD Study
Physical Description: 1 online resource (59 p.)
Language: english
Creator: Vazquez, Lauren
Publisher: University of Florida
Place of Publication: Gainesville, Fla.
Publication Date: 2009

Subjects

Subjects / Keywords: cardiology, icd, intervention, psychological, quality, women
Clinical and Health Psychology -- Dissertations, Academic -- UF
Genre: Psychology thesis, Ph.D.
bibliography   ( marcgt )
theses   ( marcgt )
government publication (state, provincial, terriorial, dependent)   ( marcgt )
born-digital   ( sobekcm )
Electronic Thesis or Dissertation

Notes

Abstract: Significant rates of psychological distress occur in implantable cardioverter defibrillator (ICD) patients. Research has demonstrated that women are a particularly at-risk group for developing psychological distress secondary to cardiac disease. The major objectives of the current study were to implement and test the effectiveness of a psychosocial group intervention in outpatient female ICD recipients vs. a wait list control group. Twenty-nine female ICD patients were recruited from Shands Hospital at the University of Florida. Fourteen women were randomized to the intervention group and 15 the wait list control group. All women completed individual psychological batteries at baseline and at one-month follow-up measuring shock anxiety, death anxiety, body image concerns, and sexual dysfunction. Pre-post measures of shock anxiety demonstrated a significant time by group interaction effect with the intervention group having a significantly greater decrease in anxiety (Pillai?s trace = 5.58, p = .03) than the control participants. A significant interaction effect (Pillai?s trace = 5.05, p = .046) was found, such that women under the age of 50 experienced greater reduction in shock anxiety, than their middle-aged cohorts. Pre-post measures of device acceptance revealed a significant time by group interaction effect with the intervention group having significantly greater increases in reported device acceptance (Pillai?s trace = 5.80, p = .02) than the control participants. Young women reported greater increased in device acceptance than both the middle- and older-aged groups, and women between the ages of 51 and 64 reported higher rates of device acceptance increase than women over 65. This study indicates that structured interventions for female ICD patients involving ICD-specific education, CBT strategies, and group social support can provide improvements in shock anxiety and device acceptance. Young women appear to be an at-risk subgroup of this population and would benefit from psychosocial treatment targeting device-specific concerns.
General Note: In the series University of Florida Digital Collections.
General Note: Includes vita.
Bibliography: Includes bibliographical references.
Source of Description: Description based on online resource; title from PDF title page.
Source of Description: This bibliographic record is available under the Creative Commons CC0 public domain dedication. The University of Florida Libraries, as creator of this bibliographic record, has waived all rights to it worldwide under copyright law, including all related and neighboring rights, to the extent allowed by law.
Statement of Responsibility: by Lauren Vazquez.
Thesis: Thesis (Ph.D.)--University of Florida, 2009.
Local: Adviser: Sears, Samuel F.
Electronic Access: RESTRICTED TO UF STUDENTS, STAFF, FACULTY, AND ON-CAMPUS USE UNTIL 2011-08-31

Record Information

Source Institution: UFRGP
Rights Management: Applicable rights reserved.
Classification: lcc - LD1780 2009
System ID: UFE0022830:00001


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1 FEMALE-SPECIFIC EDUCATION, MANAGE MENT, AND LIFEST YLE ENHANCEMENT FOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR PATIENTS: THE FEMALE-ICD STUDY By LAUREN D. VAZQUEZ 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 2009

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2 2009 Lauren D. Vazquez

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3 ACKNOWLEDGMENTS I am privileged to extend my appreciation to Dr. Samuel F. Sears, my mentor, for his continued guidance and gracious su pport in the pursuit of both th is project and my career. I am deeply honored and grateful to have worked unde r his mentorship. I would also like to extend thanks to my family and friends for their continued encouragement.

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4 TABLE OF CONTENTS page ACKNOWLEDGMENTS...............................................................................................................3LIST OF TABLES................................................................................................................. ..........6LIST OF FIGURES................................................................................................................ .........7ABSTRACT....................................................................................................................... ..............8 CHAPTER 1 INTRODUCTION..................................................................................................................102 BACKGROUND....................................................................................................................13Female Cardiovascular Patient s: Biopsychosocial Research.................................................15Female Stress Response......................................................................................................... .16Shock Anxiety.................................................................................................................. ......18Death Anxiety.................................................................................................................. .......19Body Image and Sexual Health..............................................................................................20Psychological Interventions....................................................................................................23Aims and Study Justification..................................................................................................24Specific Aim................................................................................................................... ........263 METHODS........................................................................................................................ .....27Patients....................................................................................................................... .............27Procedures..................................................................................................................... ..........27Measures....................................................................................................................... ..........28Statistical Analyses........................................................................................................... ......30Statistical Power and Sample Size..........................................................................................31Significance of Study.......................................................................................................... ....314 RESULTS........................................................................................................................ .......33Sample......................................................................................................................... ...........33Outcome Variables.............................................................................................................. ...34Exploratory Analyses........................................................................................................... ...365 DISCUSSION..................................................................................................................... ....39Summary of Results............................................................................................................. ...39Shock Anxiety and Death Anxiety.........................................................................................39Body Image and Sexual Functioning......................................................................................41Age Differences................................................................................................................ ......43

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5 Strengths and Limitations...................................................................................................... .46Clinical Implications.......................................................................................................... .....46Research Implications.......................................................................................................... ...47Conclusions.................................................................................................................... .........48REFERENCES..................................................................................................................... .........49BIOGRAPHICAL SKETCH.........................................................................................................59

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6 LIST OF TABLES Table page 2-1 Summary of studies of CBT interventions for ICD patients..............................................253-1 Summary of intervention...................................................................................................284-1 Demographic and medical variable s by total sample and groups (%)...............................344-2 Mean (standard deviation) scores on psychological measures at baseline and posttreatment...................................................................................................................... ......35

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7 LIST OF FIGURES Figure page 2-1 Proposed model of female-specific distress.......................................................................253-1 Study timeline............................................................................................................. .......293-2 Power analysis and sample size.........................................................................................32

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8 Abstract of Dissertation Pres ented to the Graduate School of the University of Florida in Partial Fulfillment of the Requirements for the Degree of Doctor of Philosophy FEMALE-SPECIFIC EDUCATION, MANAGE MENT, AND LIFEST YLE ENHANCEMENT FOR IMPLANTABLE CARDIOVERTER DE FIBRILLATOR PATIENTS: THE FEMALEICD STUDY By Lauren Danielle Vazquez August 2009 Chair: Samuel F. Sears Major: Psychology Significant rates of psychological distress occu r in implantable cardi overter defibrillator (ICD) patients. Research has demonstrated that women are a particularly at-risk group for developing psychological distress secondary to cardiac disease. The major objectives of the current study were to implement and test the effectiveness of a psychosocial group intervention in outpatient female ICD recipien ts vs. a wait lis t control group. Twenty-nine female ICD patients were recruited from Shands Hospital at the University of Florida. Fourteen women were randomized to th e intervention group and 15 the wait list control group. All women completed individual psychologi cal batteries at baseline and at one-month follow-up measuring shock anxiet y, death anxiety, body image con cerns, and sexual dysfunction. Pre-post measures of shock anxiety demons trated a significant time by group interaction effect with the intervention group having a si gnificantly greater de crease in anxiety ( Pillais trace = 5.58, p = .03) than the control participants A significant interaction effect ( Pillais trace = 5.05, p = .046) was found, such that women under th e age of 50 experienced greater reduction in shock anxiety, than their middle-aged c ohorts. Pre-post measures of device acceptance revealed a significant time by group interact ion effect with the intervention group having

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9 significantly greater increases in reported device acceptance ( Pillais trace = 5.80, p = .02) than the control participants. Young women reported greater increased in device acceptance than both the middleand older-aged gr oups, and women between the ages of 51 and 64 reported higher rates of device acceptance increase than women over 65. This study indicates that structured interv entions for female IC D patients involving ICDspecific education, CBT strategi es, and group social support can provide improvements in shock anxiety and device acceptance. Yo ung women appear to be an at -risk subgroup of this population and would benefit from psychosocial treat ment targeting device-specific concerns.

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10 CHAPTER 1 INTRODUCTION Sudden cardiac death (SCD) is the leading cause of mortality in a dults. The implantable cardioverter defibrillator (ICD) has emerged as the treatment modality of choice and has proved superior to medication alone in larg e scale trials in at risk patients.1-6 The ICD attempts to detect and correct potentially lethal arrhythmias through delivery of an automatic cardioverting shock to the heart. Despite the success of the ICD in preventing pr emature mortality in patients at risk for SCD, the psychological effects of living with an ICD can be considerable, with estimates of clinical levels of anxiet y and depression at 13-38% and 9-15%, respectively.7 Recent studies reported relatively higher rates of depression amo ng ICD patients in the United States (38%) and in Turkey (41%), that appear to be related to measurement differences.8,9 Quality of life (QOL) research has revealed that ICD recipients repo rt as good or better levels of QOL, compared to patients treated with anti-arrhythmics alone.10,11 However, ICD patients al so experience concerns with the potential for shock,12 their potential mortality,13 how the device interferes with socialization,11 and concerns with sexual functioning.11 Specific at-risk groups of ICD recipients have been identified and include patients who are female, under the age of 50, and those with a history of shock.14 While the unequivocal impact of ICD implantation on these groups has not been defined, women with cardiovascular disease are thought to be more susceptible to psychosocial distress due to a variety of biopsychosocial factors.15-21 Shock anxiety, death anxiety, a nd the ostensible change in physiognomy subsequent to implantation are thought to influence the development of distress in female device recipients. The physio logical stress reaction in fema les may also contribute to the psychosocial adjustment of living with an ICD. In itial intervention studies show that the use of

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11 cognitive behavioral therapy (CBT) with ICD patients can result in decreases in depression22,23 and anxiety,22,23 and increases in perceived adjustment22 and QOL.23 Sears and colleagues compared a CBT stress and shock management pr ogram for ICD patients delivered in either a one-day workshop or six-weekly group sessions Results revealed a reduction of anxiety ( p < .05) and cortisol concentration ( p < .05) in both the one-day workshop format and the six-week format, suggesting that interv entions involving ICD education and CBT strategies can reduce psychological distress, even in a one-day format.24 Our recent research with a multi-site, international sample of ICD patients25(N = 189) investigated the intersex psyc hosocial differences between men and women, and the intrasex psychosocial differences among younger, middle-ag ed, and older-aged females on measures of shock anxiety, death anxiety, and body image concerns. Results showed that young women (under the age of 50) reported signifi cantly higher mean shock anxiety ( p = .018), death anxiety ( p = .005), and body image concerns ( p = .018) than their olde r-aged cohorts. While no significant differences were found between men a nd women, both groups repor ted clinical levels of distress across the domains of shock anxiety and death an xiety. Similarly, women reported clinical levels of body image concerns, while their male counterparts did not. These data represent the first empirical ev idence of gender-specific and ag e-specific concerns among ICD patients. Results suggest that younger female ICD r ecipients are at risk for the development of distress and may benefit from attention to the un ique issues women face after implantation of a cardiac device.25 The main objective of the current study is to examine a one-day CBT intervention specifically tailored to female ICD patients, acro ss a variety of psychosocial markers of distress. The primary endpoints include shock anxiety an d death anxiety. Secondary endpoints include

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12 body image concerns and sexual functioning. This study will provide insight into the unique experience of being a woman with an ICD, and will examine the first female-specific psychosocial intervention study of female ICD recipients.

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13 CHAPTER 2 BACKGROUND Sudden cardiac death accounts for over 450,000 deat hs per year in the United States and is currently the highest ranked cause of mortality claiming more lives annually than stroke, lung cancer, breast cancer, and AIDS combined.26 Sudden cardiac death is pr ecipitated by the onset of potentially life-threatening ventricular tachyarr hythmias, resulting in death if not promptly defibrillated (e.g., within 10 minutes).26 The ICD is a biomedical de vice designed to contravene potentially lethal arrhythmias by automatic deliv ery of an electrical cardioverting shock to defibrillate the heart and restore normal sinus rhythm. The ICD had been identified as the treatment modality of choice for patients at risk for arrhythmias. Many large-scale, randomized, controlled trials investigating the efficacy of the ICD compared to traditional pharmacotherapy have shown that the ICD is superior in preventing premature mortality.1-6 The ICD is now implanted in approximately 150,000 Americans each year26 and implant rates are likely to continue rising dramatically, as tr eatment indications are broadened. Despite the superiority of the ICD in its abil ity to prevent premature death, the effects of living with a device can be distressing for patients. Approximately 15% of ICD patients experience clinically significan t symptoms of psychological distress related to their device.7 Sears and colleagues7 found that ICD patients have similar rates of depression as the general population, with 12-24% reporting depr essive symptoms and 9-15% me eting criteria for clinical depression. However, rates of anxiety symptoms in ICD patients exceed those of the general population, with 24-28% reporting symptoms of anxiety, and 1338% meeting criteria for a diagnosable anxiety disorder.7 Quality of life (QOL) has emerged as an endpoint of interest for many researchers investigating the psychol ogical adjustment of ICD patients. Studies show that roughly 91% of

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14 ICD patients return to previous levels of QOL within the first year of implantation.7,27 Compared to patients at risk for arrhythmias who are tr eated pharmacologically, ICD patients report as good or better levels of QOL10 except across the domains of pain and social functioning.5 A study of young adults with ICDs11 found that patients reported improved health since im plantation, ability to engage in moderate levels of physical activity, and capability to perform activities of daily living. However, patients also reported concerns with how their clot hing fit, how the ICD interfered with their levels of socializati on, and concerns with sexual functioning. Schron and colleagues12 revealed that experiencing more than one shock within the first year after implantation is associated with decreased physi cal and mental QOL. In summary, while QOL for the majority of ICD patients is desirable, sign ificant concerns may pers ist, particularly for patients with a history of shock. Researchers have identified specific groups of ICD patients who may be at an increased risk for psychological maladjustment.14 These include young patients under the age of 50, females, those with a poor understanding of their device, those with comorbid medical diagnoses, those with a premorbid history of ps ychological distress, and those who experience shock episodes during which they receive three or more consecutive shocks (also known as ICD storm). Through identifying risk factors and partic ularly at-risk groups, we are able to increase our clinical attention to thos e patients whom may be most likely to develop psychological distress and create more tailored forms of psyc hological intervention. Im plantable cardioverter defibrillator patients are vulnera ble to the development of ps ychological distress due to many factors, including ICD shock, the recognition of th eir potential mortality by cardiac disease, and the perceived lack of contro l over their medical condition.7 As such, ICD patients have been recognized as an appropriate population for the study of the development of distress.28

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15 Female Cardiovascular Patients: Biopsychosocial Research Distinct differences are evident in the pres entation of CVD between men and women. For example, women suffer from myocardi al infarctions (MI) as often as men, but the peak incidence of MI is approximately twenty years later than in men.29 Similarly, coronary disease in women develops an average of ten years later than in men.29,30 While MI and SCD are the more frequent presentations of coronary heart disease (CHD) in males, angina pectoris (chest pain) is the predominant initial presentation of CHD in females.31 The Womens Ischemia Syndrome Evaluation (WISE) study produced a large body of evid ence that there exist gender differences in the prevalence, presenta tion, and outcomes of CVD.32 Despite these gender differences in the presentation of CVD, men and wo men have the same risk factors, and CVD remains the leading cause of death for both genders.29 However, while cardiovascular mortality in men decreased between the years of 1997 to 2001, rates among women steadily increased.33 Gender differences in general cardiac physio logy have also been well established.34-37 Differences in electrocardiogram (ECG) readings ha ve revealed that women have a faster resting heart rate, a longer QT interval, a nd a lower QT dispersion than do men.34 Women also have a higher incidence of Torsades de Pointes,34,35 of mortality after the development of atrial fibrillation, and of suprav entricular tachycardia.38 It has been hypothesi zed that reproductive hormones play a considerable role in the presentation of arrhyt hmias, by modulating myocardial repolarization.38 In addition to the gender differences in gene ral CVD presentation, there also exist gender specific psychological differences among cardiac populations. Resear ch has recognized females with cardiac illness as a particularly at-risk gr oup for the development of psychological distress secondary to their disease.15-21 According to the literature, wo men experience a higher incidence of depression and anxiety after MI, stent im plantation, or CHF, in comparison with males.17,39-43

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16 This presents a considerable risk of poorer heal th outcomes for females, as increased anxiety and depression after MI is associated with higher risk of complications and mortality.44-47 Among populations of patients with congest ive heart failure (CHF), females have consistently exhibited worse QOL than males as well as increased rates of depression.43 Since CHF patients frequently require ICD implantation congruent with their cardiac disease progressi on, this population of females is explicitly at risk for adjustment difficulties. While the development of CVD and subsequent ICD implantation has traditionally been seen as an exclusively male disease, women ar e now increasingly more likely to receive an ICD as the indications for implanta tion have grown over recent years.36 Despite the growing population of women who receiv e ICDs, gender differences among arrhythmia patients have been traditionally under research ed. However, it has been recogni zed that female ICD patients are more likely to be shocked than their male counterparts,48 although the etio logy of this anomaly is seemingly unknown, since their overall risk of SCD is lower than their male counterparts.34-37 Women are highly at risk for the development of distress after ICD implantation,14,18,21 possibly due to body satisfaction issues, sexuality, femininity, and socialization,49,50 The development of psychol ogical interventions that are specifically tailored to the unique needs of females may be a step toward s providing women with a ppropriate facilitative care. Interventions could include education about the ICD, copi ng and relaxation skills training, and supportive therapy focused on specific female needs, including social support, body image concerns, and other age-specific concerns,50 Women tend to turn to their social support system in times of stress,51 suggesting that interventions that uti lize a group format may be most helpful. Female Stress Response Research has shown that there exist pronounced sex differences in stress responsiveness.52 The physiological response to stress involves the hypothalamic pituitary

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17 adrenal axis (HPA), which can be provoked by a variety of physical, mental, and social situations.52 The traditional conception of the biobehavio ral stress response has been the fightor-flight response, which suggests that humans respond to threat by beco ming aggressive or by avoidant coping.53 However, this model is incomplete as it lacks the integrat ion of the concept that as humans experience stress, they have the distinct tendency to affiliate.51,54 Taylor has labeled this social response to st ress the tend-and-befriend response.51 She asserts that when oxytocin is released in response to stress, it pr ompts affiliative behavior, in conjunction with dopaminergic and opioid systems.53 Animal studies have establishe d that oxytocin does in fact promote affiliation55 and is also thought to underlie affiliative processes in humans.53,56 Gender-specific differences in the stress respon se of females are thought to be mediated by oxytocin and endogenous opioids.57 Women consistently show st ronger affiliative processes in response to stress when compared to men.53 Estrogen enhances the effects of oxytocin which further supports a greater role of the hormone in females than in males. As a result, the tendand-befriend response is now considered a more appropriate stress resp onse pattern in women than the acknowledged fi ght-or-flight response.57 Although the fight-o r-flight response may characterize the primary physiological stress re sponse for both men and women, biobehaviorally, the tend-and-befriend response is th e more marked pattern in females.51 The impact of stress associ ated with medical illness has traditionally overlooked the issues specific to women.58 The impact of the development and treatment of CVD in females has been described by women in dist inctly feminine constructs.58 For example, family role functioning has been shown to be as predictive of the development of CVD as are biomedical risk factors.59 Psychosocial factors such as multiple role responsibilities and chronic life stress have been identified as critical to the understanding of the health status of women with CVD.60

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18 Although women on average report more stress than do men61 effective coping methods for women have resulted in improvement in QOL and an overall reduction and reported stress symptoms.62 Interventions that utilize a group format that offer women essential social support,58 that provide an opportunity to discuss the m eaning of having a potenti ally life-threatening condition,58 and that instruct women in coping strategies for dealing with emotional stress after a cardiac event62 have resulted in significant benefits among females with CVD.63 Shock Anxiety To prevent SCD in the event of an arrhythmia the ICD attempts to detect and correct the potentially life-threatening arrhythmia by the delive ry of a 35-joule shock to the patients heart. Shock has been described by patients as similar to a swift kick in the chest and is rated a on a 0 to 10 pain scale.64 Within the first year of implantation, the overall rate of prevalence of ICD shocks ranges from 10.3% to 38.5%, depending on the use of anti-arrhythmics in conjunction with ICD therapies.65 In short, shock may be a common experience for many ICD patients. Research has suggested that the occurrenc e of shock can often be a precursor to adjustment difficulties in ICD patients. Godemann and colleagues66 found that ICD patients who experienced shock were more likel y to meet criteria for this di sorder (17% non-shocked vs. 21% shocked). Sears and Conti10 state that patients who have a history of ICD fi rings are at particular risk for psychosocial difficulties. Recent research indicates that ICD patie nts who receive shocks experience more depression and anxiety, and have poorer adjustment to th e device than patients who receive no shocks.22,67 Shock anxiety, the fear of ICD sh ock that may result in increased anxiety and avoidance behaviors,68 has emerged as a construct of in terest, both in re search and in clinical settings. Even in th e minority of ICD patients who do not experience shocks, shock anxiety may result in increased avoidance behaviors and a per ceived limitation in performing everyday activities.14

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19 Sears and colleagues7 proposed the Cognitive Appraisal of ICD Activity theory, that explains how shock may lead to the development of avoidan ce behaviors and hypervigilance, which can greatly impair QOL and daily func tioning. Through operant conditioning, avoidance behaviors act as negative reinforcers that maintain feelings of fear or anxiety. Shock can also result in catastrophizing cognitions which can contribute to the de velopment of fear and anxiety about future shock (shock anxiet y). According to the theory, pa tients use the occurrence of ICD shock as an indicator of cardi ac functioning and prognosis. When pa tients experience shock, they interpret the event as a sign of declining health; conversel y, when they do not experience shock, they perceive their health as improving. Unfort unately, while this may provide patients with a false sense of understanding of their health, shock is not an indicator of failing health. Death Anxiety Death anxiety is a multidimensional construct characterized by cognitive and affective changes, physical alterations, stress, and even pain.69 Death anxiety has been described as a dynamic factor that changes with an individua ls age, experiences, and health. Tomer and Eliason70 define death anxiety as the anticipation of a state in which the self does not exist, which is variable in intensity over time. For many pe ople, death anxiety may not be a part of their everyday thoughts, although it is considered fundamental to human existence.71 Part of being human involves knowing that death is inevitable. Feelings of deat h anxiety may become a larger part of consciousness with increas ing age, after loss of a spouse or loved one, or congruent with disease progression. The experience of death anxiety can be partic ularly salient in th e presence of a life threatening illness. However, high levels of d eath anxiety may lead to avoidance of behaviors that are necessary for the maintenance of a persons health.69 For example, people with chronic health conditions, such as cardiovascular dis ease, may avoid attendi ng medical appointments

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20 because they fear what their physicians may tell them about their prognosis. Similarly, they may struggle with medication adhere nce or lifestyle modification because by adhering to medical prescriptions they would be acknowledging the fact that they have a serious medical condition. These behaviors can be described as microsuic idal in that they sl owly lead to death by reducing healthy behaviors and increasing unhealthy behaviors in their daily lives.72 In the existing literature, gende r is considered a moderating f actor in the occurrence of death anxiety. Research has established that wo men report higher levels of death anxiety, on average.73-75 Death anxiety research has revealed that fe male participants display higher levels of death anxiety than do males, regardless of th e sample population. However, more recently Neimeyer76 found that even when controlling for emotional expressiveness among gender, female participants endorsed greater death an xiety compared to their male counterparts. As an individual is faced with a life-changing event such as diagnosis of cardiac disease, survival from cardiac arrest, and subsequent IC D implantation, the frequency and intensity of death anxiety is likely to increase. This life-threat ening experience is likely to increase levels of death anxiety in ICD patients, by forcing them to face their mortality in a way that they may not have previously. Despite the he uristic value of this phenomenon, there is a notable absence of research devoted to examining d eath anxiety among cardiac populations. Body Image and Sexual Health Body image is a prevalent issue in womens h ealth research and is particularly relevant for females who undergo ICD implantation.49 Socially visible scars, similar to those created by implantation of an ICD, have been associated wi th poor self-ratings of appearance, appearance satisfaction, and appearance-related anxiety.11,77 Traditional ICD placement involves creating a 3-4 inch incision for a subpectoral or subfascial pocket in the left chest wall wherein the device

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21 is implanted. This procedure produces both vi sible scarring and bulging around the implant site due to the placement of a 78 gram/40 cm3 device underneath the skin. This protocol presents a pa rticularly sensitive problem for women, whose clothing often leaves this part of the upper body exposed. De vice placement can be ch allenging for women due to their physiognomy; the weight of the breast it self may pull and tear on incisions making the scar larger still. The practical limitations of bra straps, purse straps, and seat belts78 are consequences of device placement that have been acknowledged. Davis and colleagues79 examined the body satisfaction of women implanted with cardiac pacemakers They reported that the visibility of their scar, how their clothing fi t with the device, and the impact their device had on wearing swimsuits, were significant concerns of women, compared to their male cohorts. Although scar management techniques, including silicone gel sheeti ng and corticosteroid injections, have been outlined as appropriate treatments for a variety of abnormal scars80 little research is available in the efficacy of these me thods in the management of cardiac device scars. Several comparisons can be made between women who receive ICDs and women who undergo surgical treatment for br east cancer. In a recent study,81 women who had undergone breast conservation treatment rated the presence of highly visible scars as the single most important determinant of their perception of the cosmetic outcome of the surgery. Similarly, women have reported significant displeasure with the cosmetic outcome of their surgery and the accompanying sexual and body image sequelae, and continued to overestimate their risk of developing future cancer.82 This scenario is strikingly simila r to those women who receive ICDs for primary prevention of future cardiac events. Despite their protection from premature SCD by the device, patients have a tendency to overest imate their potential mortality by their heart condition.64 Congruous with the breast can cer literature, the changes in physical appearance that

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22 female ICD recipients experience may constitute difficulties in their perception of body image. Research indicates that women in general are mo re concerned with body image, possibly due to societal expectations that pressu re women to strive for attractiv eness. This pressure regarding their physical appearance may affect a woman s social experiences, mood, and overall QOL.83 Unfortunately, there has been little examin ation of the impact of cardiac surgery on female body image.84 Although several studies have examined cardiac disease and body image in the context of perceived physical functioning, ther e has been virtually no examination of the impact of defibrillators on body image.85 The potential dissatisfaction of cosmetic outcome of device placement and consequent body image seque lae may act as a catalyst for psychological distress in female ICD patients. The imposition of the device on a womans body, in terms of visibility and scarring, warrants increased attention to body image concerns in relation to ICD implantation. Effective multidisciplinary management of sexual health in cardiovascular patients has represented a challenge for many h ealthcare professionals. Research ers have highlighted the lack of adequate communication between patients and their healthcare pr oviders with respect to their sexual functioning.86 Hatzichristou and colleagues87 assert the general lack of awareness for approaching sex management in patients with C VD, and that physicians often embrace a diseasecentered model that fails to incorporate patient needs, such as sexual functioning. While ICD patients are members of a broa d population of what we refer to as cardiovascular patients, they represent a unique group of individuals who are faced with an equally novel set of barriers and challenges, specific to living w ith an implantable cardiac device. Patients are often forced to undergo lifestyle chan ges that include changes in marital and social

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23 relationships, particularly with regard to sexual intimacy. Cu rrently, sexual concerns in ICD patients are not well understood.88 A recent study88 investigated the psychosocial se xual experiences of a group of ICD patients after device implanta tion and found that the most co mmonly expressed concerns among the group included fear of ICD shoc k during sex, varying interest and pattern of sexual activity, and a desire for more information and sexual counseling. Walker and colleagues50 identified that between 25 and 50% of women with ICDs experi ence reproductive and sexual health concerns, yet have difficulty discussing these issues with their healthcare providers. While there exists a clear lack of empirical knowledge and rigorous research of the sexual functioning of ICD patients, the available research does suggest that patients often e xperience fears related to sexual activity that can lead to impairment in QOL. Management strategies based on psychosoc ial needs have the clear potential for increasing patient QOL,86,89 and should focus on risk factor modification and lifestyle change,90 as well as discussion of the cardiac risk of sexual activity.91 Dougherty92 suggests that as the population of cardiovascular patients who eventu ally receive ICDs c ontinues to grow, the development and implementation of ICD-specifi c sexual education for patients is largely warranted. Psychological Interventions Clinical trials using behavioral interventi ons for patients with CVD have included group formats that produced significant changes in both medical and ps ychosocial endpoints.93-95 Friedman and colleagues95 Recurrent Coronary Prevention Pr oject reported a 44% reduction in second cardiac events for those receiving group counseling that addressed psychosocial risk factors, when compared to patients receiving counseling that focused only on traditional risk

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24 factors such as diet and exercise.95 Lifestyle interventions for patients with CVD have also demonstrated reversal of coronary atherosclero sis thereby decreasing cardiac disease severity.93 In a recent literature review, Linden96 concluded that psychol ogical interventions for cardiac patients lead to reduced mortality and re duced cardiac events. He asserts that the most efficient models for improving cardiac rehabilita tion and medical outcomes would include group instructions in stress management, coping, and adherence and initiation of individual psychotherapy on a case-by-case basis if the patient e xhibits extreme levels of distress or has a particularly difficult time adhe ring to lifestyle modifications.96 The use of cognitive-behavioral therapy (CBT) with ICD patients has produced promising results. Kohn and colleagues22 found that CBT over the course of nine weeks was associated with a decrease in depression and a nxiety, and an increase in perceived adjustment, particularly for shocked patie nts. Frizelle and colleagues23 saw similar results in their sample, with CBT resulting in a decrease in depression and anxiety and an incr ease in reported QOL.24 More recently, an investigation of CBT with ICD patients measured both psychological and physiological markers of anxiety.24 Results revealed an overall d ecrease in salivary cortisol and in self-reported anxiety, ove r the course of treatment.24 Table 2-1 presents the limited studies currently available regarding CBT interventions for ICD patients. The provision of a CBT group intervention that addressed both device-specific concerns, such as stress, anxiety, and fear, as well as fe male-specific concerns, such as body image, sexual functioning, and relationship issues, is an appr opriate step towards es tablishing a routine, comprehensive care plan for female ICD patients. Aims and Study Justification The review of the relevant literature suggest s that ICD patient adjustment spans several domains, including shock anxiety, death anxiet y, body image, and sexual functioning. Female

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25 ICD patients not only experience general CVD differe nces when compared to males, but they are also highly at risk for the development of psychological distress follo wing device implantation. Table 2-1. Summary of studies of CBT interventions for ICD patients Study Major Purpose and Findings Kohn et al. (2000)22 Purpose: Compared individual CBT treatment to usual care. Results: Individual treatment group reported less depression, less anxiety, less general distress ( p <.05), despite receiving a higher level of shocks ( p <.07). Frizelle et al. (2004)23 Purpose: Compared home-based exercise/CBT group treatment to wait-listed control group Results: Treatment group showed significant improvement in depression, anxiety, QOL, number and severity of ICD concerns, and distance achieved on an exercise ability measure. Sears et al. (2007)24 Purpose: Group biobehavioral intervention vs. a workshop group. Results: Both groups demonstrated bene fit in reduced anxiety and salivary cortisol, although the long-term maintena nce of depression in the control group was shorter than in the intervention group. Psychosocial interventions for ICD patients ha ve yielded promising results, although the provision of a gender-specific intervention for female ICD patients has never been studied. Understanding how shock anxiety, death anxiety, body image, and sexual functioning are related to the ICD, and female psychosocial adjustment may provide clinicians with information to better prepare patients for ICD implantation. Therefore, the purpose of the proposed study is to examine the effects of a CBT intervention tailored specifically to females with ICDs across domains of psychosocial functioning. The following model illustrates the aforementioned female-specific adjustment issues for women after ICD implantation. Figure 2-1. Proposed model of female-specific distress ICD Implantation ShockPotential Stress Scarring Shock Anxiet y Body Image/Sex DeathAnxiet y Inflammatory Response

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26 Specific Aim Aim: To implement and test a psychosocial gr oup intervention aimed at reducing shock anxiety and death anxiety in outpatient female ICD recipients vs. a wait list control group. The four-hour one-day group intervention will include presentation of cognitivebehavioral didactic information and skills-training exercises aimed at reducing shock anxiety, death anxiety, and body image concerns. Explorati on and discussion of female-centric topics including sex and intimacy, body image, and fam ily role functioning will also be pursued. We will prospectively test the effectiveness of th e group-based female intervention on an array of outcomes spanning the domains of psyc hosocial and broad health outcomes. Primary endpoints: shock anxiety, death anxiety Secondary endpoints: body image concern, sexual dysfunction

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27 CHAPTER 3 METHODS Patients Female ICD patients (n = 30) wi ll be recruited from outpatie nt cardiovascular clinics at Shands Hospital at the University of Florida, Shands at Alachua General Hospital, and Shands Jacksonville. Patients must be at least 18 years of age, be able to read and write English, and have had prior ICD implantation. Procedures After an introduction of the study and gather ing of informed consent, women will be randomized to one of two conditions : intervention (n = 15) or wait li st control (n = 15). Medical record review will be conducted to obtain data on the following variables: cardiovascular history, ICD placement duration, history of mental health problems or treatment, current pharmacologic regimen, cardiac risk factors, and shock history. Women randomized to the intervention group wi ll be required to participate in the intervention, choosing from a range of available dates on which to attend. The intervention will only be scheduled if three or more women plan to attend. The intervention will last approximately four hours. Upon arrival on the date of the intervention, patients will complete individual psychological assessment batteries, wh ich will take approximately 15 minutes to complete. Upon completion of the psychosocial measures and part icipation in the intervention, patients will be compensated for $10. The focu ses of the intervention are summarized and broken down by hour in Table 3-1. One month after the intervention, patients will complete the follow-up psychosocial measures, either in person at outpatient cardiova scular appointments, or via mail. If patients successfully complete the psychosoc ial measures they will be compensated for $10. Four weekly

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28 Table 3-1. Summary of intervention Part 1: Research Procedures and ICD Education Fill out psychosocial questionnaires Welcome, personal introductions, intr oduction to program, and agenda Part 2: Heart Health Cardiac functioning and rhythm management Understanding shock Developing a shock plan Part 3: Stress and Anxiety Relationship between stress and anxiety Relaxation strategies Improving emotional and physical health When to consult a professional Part 4: Being a Woman Family relationships Changes in your body Romantic relationships Strategies for increasing confidence Sex and intimacy newsletters will be sent to patients after co mpleting the intervention, briefly summarizing and reminding women of the material we covered in the workshop. Women randomized to the wait list control group will complete the initial psychosocial measures at the time of recruitment, and one month after recruitment, in ou tpatient cardiovascular clinics at their residing inst itute of care or via mail. They will then be invited to partic ipate in the intervention following their completion of data collection and will be compensated for $10. Figure 3-1 outlines the timeline for recruitment, participation, a nd data collection for women rando mized to the intervention group and the control group. Measures Demographics: This measure is a brief self-repor t tool to facilitate collection of demographic information. It includes informati on such as age, ethnicity, level of education, work status, marital status, and past and/ or present psychologi cal/psychopharmacologic treatment.

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29 Figure 3-1. Study timeline Shock anxiety: The Florida Shock Anxiety Survey (FSAS)68 is a 10-item measure used to assess ICD-specific anxiety including the cognitive behavioral, emotional and social impacts of shock; alpha coefficients suggest good reliab ility (Cronbachs = .91, split-half = .92) and moderate correlation (r = -.65) with death anxi ety. Higher scores on the FSAS indicate higher shock anxiety. Death anxiety: The Multidimensional Fear of Death Scale (MFODS)76 is a 42-item assessment device with 5-point Likert response formatting. This scale is composed of eight factors: (1) Fear of the dying pro cess, (2) Fear of the dead, (3) F ear of being destroyed, (4) Fear for significant others, (5) Fear of the Unknown, (6) Fear of cons cious death, (7) Fear of the body Baseline: recruitment, sign up for intervention date Baseline: recruitment, psychosocial measures completed Treatment: completion of the one-day, four-hour intervention; psychosocial measures completed prior to intervention; patient is compensated for $10 No treatment: usual care One-month follow-up: psychosocial measures completed; patient is compensated for $10 One-month follow-up: psychosocial measures completed; patient is invited to participate in treatment and com p ensated for $ 10 Intervention GroupControl Group

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30 after death, and (8) Fear of prem ature death. For this study only the Fear of the Dying Process (6 items) and Fear of Premature Death (4 items) Scal es will be used, with lower scores indicating higher death anxiety. Previous research has calcul ated the Cronbachs alpha of reliability at .85.76 Body Image Concern: The Florida Patient Acceptance Survey (FPAS)97 is a valid and reliable 18-item measure used to assess patien t acceptance of cardiac de vice treatment. Patient acceptance refers to achieving maximal benefit from a biomedical device such as an ICD. The FPAS is composed of four factors: 1) Return to Function, 2) Device -Related Distress, 3) Positive Appraisal, and 4) Body Image Concerns The FPAS total score and subscale scores demonstrated both convergent and divergent validity with th e SF-36, Atrial Fibrillation Symptom Severity Scale, CES-D, STAI, a nd the Illness Intrusiveness Rating Scale.97 For this study, the Body Image Concerns subscale will be used as a measure of body image, which is calculated using a subset of items from the m easure. Higher scores on the Body Image Concerns subscale indicate higher levels of distress or concerns. Sexual Dysfunction: The Arizona Sexual Experiences Scale (ASEX)98 is a valid, reliable, and sensitive tool for measuring sexual dysfunc tion. This 5-item measure has both a male and a female version of the scale, and scores are used to quantify sex dr ive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Scores range from 5-30 with higher scores indicating great er sexual dysfunction. For this study the female version of the measure will be used. Statistical Analyses The primary hypothesis is that the treatmen t group will experience greater reduction in psychosocial distress relative to the wait list control group. Descri ptive and repeated measures analyses of variance (ANOVAs) will determine changes in scores between the groups. Statistical analyses will be performed to evaluate the pr oposed hypotheses for this research project using

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31 the Statistical Package for the So cial Sciences (SPSS). In order to correct for violations of the Box-M test and the Levenes test for the assu mption of homogeneity of variance, the relatively conservative Pillais trace will be used for the estimation of F-statistics in all analyses. When appropriate, Bonferroni corrections will be applied to rectify the possibility of Type I error. Statistical Power and Sample Size Previous studies by Kohn and colleagues22 and Frizelle and colleagues23 demonstrate positive effects of psychosocial stress management on ICD recipients. While no studies are available that are directly comparable to the proposed study, a small feasibility trial was conducted by Sears and colleagues24 and examined psychosocial outcomes between an intervention group vs. a workshop group. Given these similarities, sample size determination for the proposed study will be base d on effect sizes (Hedges d ) from Sears et al.24 for anxiety, d = .71 and patient device acceptance, d = .57. When conducting analyses of variance, Cohen99 large effects size as those values exceeding 0.4. As such, even using the most c onservative value of .57, this would require approximately 26 subjects per group for the recommended power of .80 when alpha = .05 two group comparisons. The average psychosocial effect size among those reported from the Sears et al.24 trial is approximately .70; we used this effect size to con duct power analysis for this study. A projected sample size of n = 30 gives a power of .80 for this estimated effect size. Figure 3-2 depicts the relationship between number of variables and powe r attained based on repeated measures analyses using the anxiety variable (u tilizing the Greenhouse-Geisser Corrected F term). Significance of Study Our study represents advancement in the development of appropriately tailored interventions for female ICD recipients, as part of comprehensive faci litative care for women

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32 with CVD. Sudden cardiac death remains the most common cause of mortality for both men and women. The ICD has emerged as th e most efficacious treatment choi ce for those patients at risk for SCD,1-6 but while the number of women who unde rgo ICD implantation annually continues to increase,36 the existing literature focused on female ICD populations is largely lacking in both breadth and depth. While QOL after ICD implan tation is largely depe ndent on the degree of psychological distress experienced by patients, psychosocial interv entions targeted at reducing psychological distress can produce QOL outcomes that make ICD therapy beneficial. The current study establishes the utility of a fema le-specific psychosocial intervention to reduce psychological distress and pr oduce optimal QOL outcomes. Power vs n by Terms with K=1.00 GG F Test B W BW Power Terms n 0.0 0.1 0.2 0.3 0.4 0.6 0.7 0.8 0.9 1.0 202530354045 Figure 3-2. Power analysis and sample size

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33 CHAPTER4 RESULTS Sample Table 4-1 provides demographic and medical information for the total sample, intervention group, and wait list control group. The majority of the sample identified themselves as being Caucasian (93.1%), married (75.9%), having had at least some college ed ucation (72.3%), and being retired (41.4%). With regards to psycholog ical history, the major ity of women reported past psychopharmacologic (44.8%) or psychologi cal (37.9%) treatment. Five women endorsed current psychopharmacologic treatment and one women reported bei ng in individual psychotherapy (for reasons unrelated to her device or illness). Patients medical records were reviewed to obtain cardiovascular a nd ICD-specific history. For the total sample, mean time since ICD implantation was 3.78 3.07 years. Thirty-four percent of women had received shock therapies prior to enro llment in the study. Regarding cardiovascular diagnoses, 72.4% had congestive heart failure, 37.9% ha d coronary artery disease, and 10.3% had long QT syndrome. Twenty-four percent of women had a history of sudden cardiac arrest, and 24% had suffered a myocardial infarction. Chi-square analyses were conducted for all demographic and medical variables to assess for any significant differences between groups at study onset. No signifi cant differences in variables existed betw een the intervention and control groups (using p < .05), suggesting that these groups were similar, on average, acr oss psychosocial and h ealth-related domains.

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34 Table 4-1. Demographic and medical va riables by total sample and groups (%) Total Sample n = 29 Intervention n = 14 Control n = 15 Age (M SD) 55.6 15.5 57.4 14.8 53.9 16.4 Ethnicity Black/African American 3.4 7.1 0.0 American Indian/Alaskan Native 3.4 7.1 0.0 White/Caucasian 93.1 85.7 100.0 Marital Status Single 6.9 7.1 6.7 Divorced 13.8 21.4 6.7 Married 75.9 71.4 80.0 Living with a partner 3.4 0.0 6.7 Level of Education High school 27.6 28.6 26.7 Some college 41.4 35.7 46.7 Associates degree 17.2 21.4 13.3 University degree 13.7 14.2 13.3 Occupational Status Working 20.7 21.4 20.0 Homemaker 3.4 7.1 0.0 Unemployed 3.4 0.0 6.7 Retired 41.4 42.9 40.0 Medically disabled 31.0 28.6 33.3 Psychopharmacologic Treatment Past 44.8 42.9 46.7 Current 17.2 21.4 13.3 Psychological Treatment Past 37.9 42.9 33.3 Current 3.4 7.1 0.0 Years with ICD (M SD) 3.78 3.07 4.12 3.75 3.46 2.35 Positive shock history 34.5 42.9 26.7 Cardiovascular History Congestive heart failure 72.4 64.3 80.0 Coronary artery disease 37.9 42.9 33.3 Long QT syndrome 10.3 7.1 13.3 Prior sudden cardiac arrest 24.1 28.6 20.0 Prior myocardial infarction 24.1 28.6 20.0 Outcome Variables A series of repeated-measures analyses of variance (ANOVAs) were employed to examine differences in psychological outcomes over th e course of the study. For all analyses, time

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35 (baseline, 1-month follow-up) was the with in-subjects factor and treatment condition (intervention group vs. c ontrol group) was the be tween-subjects factor. In order to correct for violations of the Box-M test and the Levenes test for the assumpti on of homogeneity of variance, the relatively conservative Pillais trace was used for the estimation of F-statistics in the analyses that follow. Tabl e 4-2 provides means, standard deviations, and levels of significance for the intervention and contro l groups for all psychological endpoints. Table 4-2. Mean (standard devi ation) scores on psychological measures at baseline and posttreatment Intervention Control p-value* FSAS (baseline) (post-treatment) 22.79 (10.76) 17.93 (6.02) 19.73 (8.65) 19.13 (7.85) .026 MFODS 26.07 (11.13) 27.50 (9.84) 27.93 (9.60) 28.47 (10.73) NS FPAS (Body Image Concerns) 28.57 (34.47) 24.11 (32.32) 17.50 (23.05) 19.17 (20.52) NS ASEX 16.43 (6.00) 18.21 (5.01) 15.93 (4.45) 17.07 (5.61) .016 FPAS (total) 69.52 (16.30) 78.93 (17.03) 70.89 (19.76) 71.11 (19.33) .026 FSAS = shock anxiety, MFODS = death anxiety, FPAS (Body Im age Concerns Subscale) = body image concerns, ASEX = sexual dysf unction, FPAS (total) = device acceptance *p-value statistic for time by group interaction effects NS = non-significant Shock anxiety and death anxiety: Pre-post measures of shoc k anxiety demonstrated a significant time by group interact ion effect with the interven tion group having a significantly greater decrease in anxiety ( Pillais trace = 5.58, p = .03, p 2 = .17) than the control participants at one-month follow-up. This reduction in shoc k anxiety in the intervention group was significant at the p = .05 level. Measurement of death a nxiety at baseline and 1-month follow-up did not produce significant changes or interac tions in the intervention or control groups.

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36 Body image concern and sexual dysfunction: There were no signi ficant changes or interactions across the study in reported body image concerns, among the two groups. Measures of sexual dysfunction in the study demonstrated a significant time by group interaction effect with the intervention group having a significantly greater increase in reported sexual dysfunctions ( Pillais trace = 6.66, p = .02, p 2 = .20) than the control pa rticipants. This increase in sexual dysfunction in the intervention group was significant at the p = .05 level. Device acceptance: The FPAS, a measure of device acceptance, was administered at baseline and 1-month follow-up. Pre-post measur es of device acceptance revealed a significant time by group interaction effect with the interven tion group having significantly greater increases in reported device acceptance ( Pillais trace = 5.80, p = .02, p 2 = .18) than the control participants. The intervention group increase in overall device acceptance was significant at the p < .01 level. Exploratory Analyses Exploratory analyses were conducted to exam ine differences in rates of total device acceptance between the intervention and control gr oups, as this construct has emerged as an endpoint of interest among the cardiac device population. Additionally, differences in selfreported shock anxiety, sexual functioning, and device acceptance among three age groups of females were also examined, as recent literature suggests significant diff erences in psychosocial functioning among varying aged females. Finally as rates of sexual dysfunction among women with ICDs has previously been unexplored, se lf-reported sexual functioning was examined across the entire sample at baseline, to identify a nd define base rates of sexual dysfunction in the general female ICD population. Age group differences: For categorical age analyses, women in the intervention group were divided into three groups: young ( 50 years of age; n = 4), middle-aged (51-64; n = 6), or

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37 older ( 65 years of age; n = 4). Significant time by group interactions were found across the domains of shock anxiety, sexual functioning, a nd device acceptance. With regards to shock anxiety, a significant interaction effect ( Pillais trace = 5.05, p = .046, p 2 = .32) was found, such that women under the age of 50 experienced grea ter reduction in shock anxiety, than their middle-aged cohorts. Notably, young women had highe r rates of shock anxiety (M = 30.75) than middle(M = 18.00) and older-aged (M = 22.00) women at baseline. All age-groups showed reduction in shock anxiety from baseline to one-month follow-up, on average. Rates of sexual dysfunction increased ( Pillais trace = 5.91, p = .03, p 2 = .35), with a significant time by group interaction effect such that young women and older women reported significantly higher rates of dysfunction at follow-up than their middle-aged cohorts. Significant time by group interactions were found for reported device acceptance at baseline and one-month follow-up ( Pillais trace = 9.35, p < .01, p 2 = .46). Young women reported greater incr eased in device acceptance than both the middleand older-aged gr oups, and women between the ages of 51 and 64 reported higher rates of device acceptance increase than women over 65. Again, it is notable than young women reported poorer device acceptanc e on average (M = 55.42) than middle-aged and older-aged women (M = 75.28 and M = 75.00, respectively). Howeve r, all groups reported greater increases in total device acceptance increas ed across time, on average. Rates of sexual dysfunction in total sample: The ASEX, a measure of self-reported sexual dysfunction, was completed by all participants. Sexual dysfunction has been defined as a total ASEX score 19, any one item with a score 5, or any three items with a score 4. Previous rates of sexual dysfunction are unknown for female ICD recipients. Of the total sample (N = 29), 9 women (31%) had a total baseline ASEX score 19, 2 (7%) had any one item with a

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38 score 5, and 0 women had any three items with a score 4. In all, 11 out of 29 women (38%) met criteria for sexual dysfunction at baseline measurement based on ASEX scoring criterion.

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39 CHAPTER 5 DISCUSSION Summary of Results Our major objectives were to investigate th e effectiveness of a ps ychosocial intervention tailored for female ICD recipients across a variety of outcomes. Sp ecifically, this study investigated through repeated measures analyses of variance, the effect of the intervention on self-reported shock anxiety, death anxiety, body image con cern, and sexual dysfunctions. Results suggest that psychosocial treatment for female ICD recipients is effective in improving QOL outcomes across several domains. Hi storically, the provision of psychosocial interventions utilizing CBT strategies for the general ICD population has resulted in decreased anxiety 22,23,100 and depression. 22,23 More recently, a CBT intervention program resulted in reductions in both psychological and physiologica l markers of anxiety in shocked ICD patients.13 While psychosocial treatment has demonstrated utility for the gene ral ICD population, it has been suggested that these interventions are not one size fits all, and that interventions tailored to meet the specific needs of particular ICD subgroups are warranted. This study provides evidence that tailored interventions have both clin ical and research utility in the female ICD population. Shock Anxiety and Death Anxiety Intervention group members in the study repor ted significant reductions in shock anxiety after participation in the intervention. The expe rience of ICD shock has been associated with poor QOL12and has been implicated in the development of anxiety101and depression.102 However, while a sizable portion of ICD patients w ill experience shock within the first year after implantation, the majority of patients will not.103 Despite these statistics, many more patients experience clinical symptoms of distress associ ated with shock fears, than experience shock

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40 itself, suggesting that shock anxiet y is an appropriate target for psychosocial treatment. Shock is an uncontrollable and often aversi ve situation that is unavoidable by ICD patients. As such, the prospect of shock can lead to feelings of helplessness. Pauli and colleagues104suggest that distress may be related to the specific thinking patterns that ICD patients engage in. Catastrophic cognitions are especially harmful fo r ICD patients as they lead to ne gative appraisal of the device through fear centered on the possibility of shock. It has been well established that patients desire more knowledge about their device.13 Patient education is an essential component to psychosocial treatment, particularly with regards to identifying and challenging IC D-specific concerns, such as how the device functions, events that may trigger shock, and what to do in the event of a shock.105 In this study, the delivery of psychoeducation regarding shoc k experience and developing a shock plan, as well as encouraging members to process their shock hi story were all components of the intervention, providing further evidence in th e importance of ICD-specific e ducation and the targeting of shock anxiety. Shock anxiety can be defined as the fear or an ticipation of ICD shock that often results in increased heart-focused anxiety symptoms, as well as the development and maintenance of avoidance behaviors to minimize their perceive d risk of shock. Shock anxiety represents a device-specific and novel anxiety that is distinctly related to the ICD, versus a more generalized or trait anxiety. Therefore, ps ychosocial interventions that pr ovide psychoeducation about the ICD and device-related fears and concerns may be particularly valuable in reducing shock anxiety because they address this novel stressor in the appropriate context. Women in our study did not report significant reductions in death anxiety. Many female ICD recipients have experienced sudden cardiac d eath and have been faced with the prospect of

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41 dying. While the ICD has been widely established as a life-saving device, some patients appear to have significant anxiety related to the device and fears of death.104 Despite a lack of significant results in this study, deat h anxiety still appears to be a particularly relevant construct to this population of patients, given the onset of their cardiac dis ease coupled with the implantation of an ICD as a constant reminder of their potential mortality. Death anxiety is a multidimensional construct characterized by cognitive and affective changes, physical alterations, and stress. Death anxiety can be partic ularly salient for patients suffering from a life threatening illness. As descri bed in the background, death an xiety is considered to be fundamental to human existence. It is a dynamic factor that changes with an individuals age, experiences, and health. It is a construct that varies in inte nsity over time. However, death anxiety can certainly be viewed as a conti nuous, albeit variable, construct throughout the lifespan, influenced by a variety of societal and personal factors. As such, the provision of a psychosocial treatment in a one-day group interven tion may not be the most effective treatment delivery in targeting the c onstruct of death anxiety. Body Image and Sexual Functioning Although rates of body image concerns did not significantly improve across the study, women reported a reduction in concerns, on averag e. Previous research has established that women tend to report body image dist urbances after physical scarring.77 Anxiety about appearance secondary to implanta tion of an ICD can result from th e noticeable scarring that can affect body image in recipients. Women in west ern societies may be more concerned with body image, possibly due to societal expectations that pressure women to strive for attractiveness and affect social experien ces, mood, and overall QOL.83 Nonetheless, very little research has investigated rates of body image c oncerns in female ICD populations.85 While the current study did not yield significant results with regards to bo dy image, further explora tion of this construct

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42 is certainly warranted. In particular, female ICD recipients would likely benefit from welldeveloped treatment protocols that include a variety of implant options, preand post-operative education, and plastic surgery consultation. Pr ior to scheduling devi ce implantation, female patients may benefit from being offered all plac ement options available, in addition to the standard device information routinely offered ICD patients pre-operatively. The measurement and development of biopsychosocial intervention s that target the body im age construct in this population of women would certainly be valuable. Women in the current study reported higher rate s of sexual dysfunction after participation in the intervention. However, th ere is no reason to believe that this intervention created an adverse effect of increasing se xual dysfunction. We suggest that discussion of sexual functioning and intimate relationships during the interventi on might have encouraged women to think more accurately about their sexua l health, thus reporting higher rates than they did at baseline. Likely, women felt more comfortable reporting their ac tual level of sexual dysfunctions at the onemonth follow-up period, versus disclosing such se nsitive information before establishing rapport. As such, the post-test data is likely to be a more accurate interpretati on of rates of sexual dysfunction among women with IC Ds. Walker and colleagues106 identified that between 25-50% of women with ICDs experience reproductive and sexual health c oncerns yet have difficulty discussing these issues with their healthcare providers. They might also have difficulty identifying these issues themselves. While it makes sense heuristically that ICD patients face challenges associated with sexual intimacy, sexua l concerns in ICD patients are currently not well understood.107 This study is the first to our knowledge to establish base rates of sexual dysfunction in the female ICD population. Based on our results, appr oximately 38% of females with ICDs report

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43 symptoms consistent with a diagnosis of so me sexual dysfunction. These results suggest the overwhelming importance of attention to this aspect of female hea lth. It has been suggested that physicians have a general lack of awareness for approaching sex management in patients with cardiovascular disease.87 An area that is frequently ove rlooked by physicians is that of intimacy,88 despite the fact that a clear opportunity exists for cardiologists to help enhance emotional well-being and overall QOL in their patients by approaching this area of health functioning.108 Psychologists possess a unique perspective for treating sexual dysfunctions, and can contribute significantly in the management by healthcare team. For instance, psychologists would be proficient in addressi ng patient fears of sexual activity that often prevent complete rehabilitation sexually from cardiovascular disease.109 Psychologists also have the expertise needed to help patients with lifestyle modifica tion such as weight loss and increasing physical activity, in an effort to promot e better overall vascular health.90 Hatzichristou and colleagues87 point out that management strate gies should center around the fact that patients and their partners are constantly forced to adjust to the chronicity of heart disease and the ever-changing reality of their sex lives; health psychol ogists obviously have a mastery of a set of broad-based skills necessary to help patients ad just with such illnesses. There exist many barriers to the effective ma nagement of sexual health in female cardiovascular patients. Results from this study suggest that multidisciplinary effort, involving effective treatment strategies focused on patient medical, psychological, and social needs should certainly be pursued. Age Differences As in other studies of female ICD recipients,25 women under the age of 50 reported higher rates of shock anxiety, more sexual dysf unction, and poorer rates of device acceptance

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44 than their older cohorts. While the absolute numbe rs for each age group were very small, results still showed greater rates of change in this group of females after participation in the intervention, suggesting that they are highly ap propriate candidates for psychosocial treatment subsequent to device implantation. It could be argued that age fi ndings were significant due to younger women reporting poorer rates of psychosocial functioning at baselin e. However, as all age groups tended to improve across the course of the study, on average, it is unlikely that this is the case. Regardless, young women appear to be a particularly at-risk gr oup for the development of psychological distress after implantation, a nd would benefit from psychosocial treatment targeting device-specific concerns. Previous data have suggested the investiga tion of females with ICDs is warranted. Two reviews by Yarnoz and Curtis110,111 comprehensively detailed the literature on gender differences in electrophysiology and arrhythmia outcomes, as well as medical treatment interventions (i.e., ICD placement and cardiac resynchronization ther apy [CRT]). Across both reviews, female gender was determined to be associated with great er heart rate, greater in cidence of inappropriate sinus tachycardia, greater preval ence of atrial fibrillation (AF) greater AF symptom frequency and AF-related complications, greater prevalence of congenital and acquired long QT syndrome, and lower ICD implantation rate s. Women are generally unde rrepresented in ICD and CRT trials, likely in part because they may present with symptoms at a later age than men, are less likely to have heart failure and CAD prior to card iac arrest, and are less likely to have severe systolic dysfunction all of which make indi cation for treatment less noticeable. The ICD appears to provide equal survival benefit acro ss genders, however. Womens experiences with electrophysiological disorders are also uniquely affected by sex-specif ic factors such as pregnancy, menopause, and hormonal triggers.110,111

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45 Given womens under representati on in these interv ention trials, it is not surprising that there is a dearth of literature elucidating the e ffects of gender on psycholog ical adjustment to the ICD. However, in an updated review of adjust ment in ICD patients from Sola and Bostwick,112 six studies found female recipien ts being disadvantaged toward poorer psychological adjustment, including depression, anxiety, body imag e distress, social role loss, and/or sleep difficulties. In a sample of more than 450 IC D patients with non-ischemic cardiomyopathy, women were more likely to report greater declines in physical health-related QOL than men.24 Although no differences in depression and a nxiety were noted, Smith et al.113 found in their sample of approximately 250 ICD recipients that women were more likely to be younger in age, to be unmarried, to have greater heart failure severity, and reported great er functional status declines, more symptoms of pain, and more sleep loss. As noted above, younger age has been identified as a predictor of future psychological difficulties in ICD patients.10 Bainger and Fernsler114 found both young age and unemployment status to be associated with gr eater QOL deficits. In a review th at included 16 studies, Thomas et al.115 state explicitly that younger reci pients are at highest risk for future psychological and QOL difficulties (p. 389). Further, our recent in vestigation of female ICD patients revealed that women under the age of 50 appear to be at greater risk for the development of psychosocial distress associated with shock a nxiety, death anxiety, and body image.25 Dubin and colleagues11 examined QOL in recipients less than 40 years of age and found high rates of concerns related to how the device would impact clothing, social func tioning, and sexual activity. Results from this study further strengthen this body of literature, an d emphasize the utility of tailored psychosocial treatment for this group of females.

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46 Strengths and Limitations When interpreting results from this study, ther e are several strengths and limitations that should be taken into consideration. Analyses eval uating this sample found participants to be relatively equivalent to each ot her in regards to demographic and medical variables. Despite power analyses suggesting an adequate sample size, our study population may be considered relatively limited in the number of patients participating in data collection. This limitation may have resulted in reduced significant findings regardi ng the stated hypotheses. As with all research, consideration of self -report measures shoul d be made; self-report measures may be influenced by patient demand char acteristics, such as participant perception of how they should respond or would like themselv es to be perceived. The measures used in assessing psychosocial functioning in patients were restricted to the use of standardized and validated measures that were chosen for their es tablished reliability and validity in measuring the constructs of interest. We also attempted to minimize the influence of demand characteristics by assuring confidentiality of responses a nd anonymity after data collection. Clinical Implications Collectively, results from this study highlight the utility of comprehensive psychological care for women with ICDs. The existing lack of rese arch in the female-specific adjustment to the ICD represents absence of innovation in the ar ea of comprehensive care for women. Without such innovation, healthcare profe ssionals fail to provide universa l comprehensive care to the female ICD recipients. With appr opriate facilitative care, some female ICD patients may return to previous levels of physical and psychosoc ial functioning. The curre nt study identifies the utility of this tailored psychosocial interventi on for females with ICDs across a variety of QOL outcomes, particularly for those under the age of 50. This study also identifies further avenues for research and clinical atten tion, namely female sexual healt h. Clinicians can utilize this

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47 information to improve outcomes in ICD reci pients by providing patients with increased attention to their psychological needs and referrals for psychoeducational interventions when indicated. This study provides evidence that female IC D patients may experience improved health outcomes through a combination of optimal medi cal treatment and tailo red psychosocial care, including the delivery of psychoe ducation and affiliation with other females in a support group format. This process can be facilitated by the inte gration of cardiac psychol ogists as an essential component of the electrophysiol ogy team. As therapies continue to advance, female ICD patients, particularly those unde r the age of 50, may benefit from well-established guidelines that take into consideration the unique issues women face with the implantation of a cardiac device. Research Implications The review of the relevant literature to date suggests that the female-specific adjustment to the ICD has not been thoroughly assessed. The cu rrent study substantiall y adds to this body of literature, in the investigation of the first psychosocial intervention tailored to female ICD recipients. The continued investigation of the unique issues women face in living with an ICD, as well as effective treatment strategies are not eworthy, as they could largely improve QOL, adjustment, and psychological fitn ess of female ICD recipients. Future research focused on attention to fe male sexual health among the device population is also indicated. The current st udy provides useful information in this regard, but future studies could more specifically address this topic. While this type of analysis was beyond the original scope of the current study, it is clearly an extension that is im plicated from the findings and should be incorporated in future research endeavors.

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48 Conclusions In summary, the ICD is a life-saving device whose use is increasi ng annually. Although the effectiveness of its life-saving utility is well established, QOL and adjustment issues persist. Women in particular appear to be a vulnerab le subpopulation for devel oping subsequent distress after implantation, especially those under th e age of 50. The current study suggests that structured interventions for female ICD patients involving ICD-specific education, CBT strategies, and group social s upport can provide improvements in shock anxiety and device acceptance. In closing, the findings from this study suggest that female ICD patients should be referred for psychological intervention to minimize adjustme nt difficulties and possible declines in QOL after ICD implantation. Subsequent to implant, young women appear to be highly at risk for the development of psychosocial distress. More cons iderable attention is warranted in women under the age of 50 by researchers and clinicians alike, as this population has be en identified to be increasingly more likely to receive an ICD as th e indications for implantation continue to grow exponentially.36

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59 BIOGRAPHICAL SKETCH Lauren Danielle Vazquez graduated cum laude from the University of Florida in May 2004 with a Bachelor of Health Science degree in health science and a B achelor of Science in psychology. She also earned a Master of Sc ience degree in psychology from UF in May 2006. She has been pursuing a Ph.D. in the UF Depart ment of Clinical and Health Psychology since August 2004. Her clinical and research interests lie in medical and health psychology, with a focus on cardiovascular disease and heart rhythm management.