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168 CLINICAL STUDIES A Controlled Pilot Study of Stress Management Training of Elderly Patients With Congestive Heart Failure Frederic Luskin, PhD; Megan Reitz, BA; Kathryn Newell, MA; Thomas Gregory Quinn,
168 CLINICAL STUDIES A Controlled Pilot Study of Stress Management Training of Elderly Patients With Congestive Heart Failure Frederic Luskin, PhD; Megan Reitz, BA; Kathryn Newell, MA; Thomas Gregory Quinn, MD; William Haskell, PhD From the Stanford Center for Research in Disease Prevention, Stanford University School of Medicine, Palo Alto, CA Address for correspondence: Frederic Luskin, PhD, Stanford Center for Research in Disease Prevention, 730 Welch Road, Suite B, Palo Alto, CA Manuscript received July 10, 2001; accepted September 4, 2001 The purpose of this study was to evaluate the effect of stress management training on quality of life, functional capacity, and heart rate variability in elderly patients with New York Heart Association class I III congestive heart failure (CHF). While substantial research exists on stress management training for patients with coronary heart disease, there are few data on the value of psychosocial training on patients with CHF. Thirty-three multiethnic patients (mean age, 66±9 years) were assigned through incomplete randomization to one of two treatment groups or a wait-listed control group. The 14 participants who completed the treatment attended eight training sessions during a 10-week period. The training consisted of 75-minute sessions adapted from the Freeze-Frame stress management program developed by the Institute of HeartMath. Subjects were assessed at baseline and again at the completion of the training. Depression, stress management, optimism, anxiety, emotional distress, and functional capacity were evaluated, as well as heart rate variability. Significant improvements (p 0.05) were noted in perceived stress, emotional distress, 6-minute walk, and depression, and positive trends were noted in each of the other psychosocial measures. The 24-hour heart rate variability showed no significant changes in autonomic tone. The authors noted that CHF patients were willing study participants and their emotional coping and functional capacity were enhanced. This program offers a simple and costeffective way to augment medical management of CHF. Given the incompleteness of CHF medical management and the exploding interest in complementary medical intervention, it seems imperative that further work in psychosocial treatment be undertaken. (Prev Cardiol. 2002;5: , 176) 2002 CHF, Inc. Congestive heart failure (CHF) is the only major cardiovascular disorder that is increasing in incidence, prevalence, and overall mortality. Recent studies estimate the prevalence of CHF at almost 5 million persons in the United States, leading to hospitalization of 900,000 patients each year. 1 Improvements in survival after myocardial infarction, better management of diabetes and hypertension, and an increase in the aging population have contributed to the rise in CHF. 2 The hallmark of CHF is exercise intolerance and activity restriction, most commonly due to symptoms of dyspnea and fatigue. These symptoms are debilitating and result in low functional capacity and progressive physical disability, often requiring intensive medical management, follow-up, and hospitalization. In addition to physical decline, these patients often report depressed mood, anxiety, and increased hostility. 3 A structured interview with 60 hospitalized CHF patients (aged 70+ years) showed that 17% of the participants met the Revised Diagnostic and Statistical Manual of Mental Disorders (DSM III) criteria for major depression. The patients who were depressed required a greater number of inpatient hospital days and, at 1 year, showed greater mortality. 4 Patients with CHF are known for very high mortality rates, as well as the highest hospital readmission rates of all patient populations. 5 This may be partly due to the psychosocial consequences of the disease process, which includes behavioral restrictions, as well as comorbid depression and anxiety. A study that evaluated quality of life of CHF patients found no significant relationship between a patient s cardiac ejection fraction and any quality of life measure. 2 However, self-reported functional status, depression, and hostility were significant indicators of quality of life among these patients. FALL 2002 PREVENTIVE CARDIOLOGY 169 Recent studies have shown that sympathetic activation is one of the hallmark physiologic abnormalities in CHF. Circulating catecholamine levels have been associated with increased severity of disease and unfavorable prognosis. 6 As a result of these studies, the neurohormonal hypothesis has emerged as the leading paradigm for understanding the progression of CHF. 7 Pharmacologic therapies that alter autonomic balance, such as angiotensin-converting enzyme inhibitors and β blocking agents, have become standard therapy for CHF patients. 8 However, noncompliance can be a significant problem in pharmacologic treatment. Monane et al. 9 noted that among elderly CHF patients on digoxin, only 10% were completely compliant with the prescribed regimen over the course of a year. The use of β blockers elicits better adherence, yet medical management of CHF is still incomplete. 10 Sullivan and Hawthorne 11 reviewed the nonpharmacologic interventions for CHF. They cite the effectiveness of longterm aerobic exercise conditioning programs and make the case for offering psychological and biobehavioral interventions to enhance outcome and quality of life. To test their hypothesis, they examined the effect of structured nursing care for CHF patients in order to reduce readmission rates and improve quality of life. 4 The study results showed that patients with CHF experienced major mood disturbances greater than those reported by other cardiac patients. This mood disruption was directly related to patients quality of life and highlighted the need for concurrent psychosocial intervention. Interestingly, this study found exercise tolerance to be unrelated to patients ejection fractions but related to quality of life. To date, there are two studies that included a psychosocial intervention as an aspect of a clinical trial. As one arm of a study, CHF patients were offered an intervention that included exercise training, structured cognitive therapy, and dietary training. This intervention improved functional capacity, body weight, and mood state. 12 The second 13 was a pilot study in which New York Heart Association (NYHA) class II IV CHF patients taught the Freeze-Frame 14 stress management program showed significant improvement in coping with stress and a trend toward increased self-confidence related to their physical fitness. Previous research had shown the short-term positive effects of Freeze-Frame to include enhancement of heart rate variability and modification of sympathetic arousal in healthy volunteers. 15,16 This study attempted to measure participants autonomic balance, but the severity of NYHA class III IV CHF prevented adequate recording of 24-hour heart rate variability. Compromised heart rate variability was the factor that best predicted early death from progressive heart failure. 17 Stress management and relaxation training are psychosocial practices that can reduce sympathetic arousal. Research shows the usefulness, in both primary and secondary prevention, of stress management training in patients with coronary artery disease. 18 This current study builds upon the authors previous study through recruiting and randomization of a larger number of participants with less severe CHF. RESEARCH DESIGN AND METHODS Participants The initial study sample consisted of 13 men and 20 women with an average age of 66±9 years. Thirteen participants were middle-class Anglo- Americans, with one Asian American woman, and were invited to participate by the nurse at a local cardiac rehabilitation facility. Nineteen participants were inner city, low socioeconomic status African American, Asian American, or Latino patients, and were invited to participate by their cardiologists. Subjects had been diagnosed as having NYHA class I to very early class III CHF at least 3 months previously and had been on a stable medication regimen for at least 1 month. A cardiologist evaluated each patient s medical file and certified each participant as eligible for the study. Stanford University s Institutional Review Board approved this project. Participants were assigned to either of two treatment groups or to the wait-listed control group through incomplete randomization. Full randomization was attempted, but because only one class was held per location, four participants in the treatment group could not make the training sessions and became control group participants. Subsequently, five control group members were assigned to the treatment groups. Control group members were invited to attend a 1-day training at the completion of the intervention. Intervention All participants received the same 10 hours of training offered during eight weekly 75-minute sessions spread over 10 weeks. The two treatment groups followed the same topical outline that was taught by one of the authors (Frederic Luskin), a licensed psychotherapist. The training was primarily didactic in nature, with an emphasis on guided practice of the techniques. A limited amount of time was set aside for participant sharing of personal experience. After each session, participants were given practice assignments for the week. The stress management techniques taught were Freeze-Frame, Heart Lock-in, Appreciation and Care vs. Overcare. Freeze-Frame is the basic stress management technique and starts with the conscious shifting of attention from a stressful experience to the area around one s heart. After taking a few slow, deep breaths into the area around the heart, one s attention is drawn to a visualization or memory of a positive emotion, such as care or love. Then the feeling generated by that positive emotion is held in the area around the heart. Heart Lock-in is an extended Freeze-Frame, while Appreciation is learning to focus attention on positive experiences. Care is distinguished from Overcare. Overcare is defined as the tendency to want something or someone so much that the extra effort and/or anxiety obscures the positive experience of care and leads to distress. 170 The class outline was as follows: 1. Orientation and class overview. Review research on the effectiveness of practice of Freeze-Frame. Guided practice in Freeze-Frame. 2. Review of research on effectiveness of stress management in cardiovascular disease. Review of what stress does to the body. Review of Freeze- Frame. Guided practice in Heart Lock-in. 3. Discussion of stress management practice as a form of complementary medicine. Discussion of importance of self-care. Presentation of concept of Appreciation. Guided practice in Freeze-Frame. 4. Discussion of secondary gain (behavior that on the surface appears unproductive has personally relevant reason for continuation). Discussion of the difficulty in changing patterns of response. Brainstorming for suggestions. Guided practice in Heart Lock-in. 5. Practice in thinking of ways to include Freeze- Frame in daily life. Teaching of other simple stress management tips, such as deep breathing and taking a moment before making decisions. Guided practice in Heart Lock-in. 6. Discussion of Care vs. Overcare and implications for stress management. Presentation of the concept of finding the Care rather than the Overcare in each situation one encounters. Guided practice in Heart Lock-in. 7. Presentation of mental health as partly the choice of how one responds. Emphasis on decisions that primarily manifest either Care or Overcare. Teaching, through class examples, that suffering is the result of Overcare crowding out Care. Guided practice in Heart Lock-in. 8. Review of course material. Reminders for future practice, creation of an ongoing practice routine that does not vary, and emphasis on continued practice. Participant feedback on training. At the conclusion of each class period, participants were given homework practice suggestions. Beginning with the second session, each participant was asked to do one Heart Lock-in per day for 15 minutes. Starting with session 4, each participant was asked to do two Heart Lock-ins per day. In addition, starting with the first session, participants were asked to do at least three Freeze-Frames per day, as well as look for opportunities during the day to practice Freeze-Frame. Measures All measures were administered 1 2 weeks before the training began (pretest) and 1 2 weeks after the training ended (post-test). 1. Geriatric Depression Scale: measures participant s level of negative affect Perceived Stress Scale: measures participant s perceived level of stress and ability to cope Life Orientation Test: measures subject s level of positive expectation or optimism State Trait Anxiety Inventory: measures stable or dispositional expression of anxiety Medical Outcome Survey Questions 3 and 9: two of the multi-item self-report questions were evaluated that ask participants to rate their ability to complete basic activities and the quality of their emotional experience Minnesota Living with Heart Failure: a quality of life measure evaluating the degree to which CHF interferes with the completion of normal life tasks Self-report physical fitness: participants are asked to rate their confidence in their physical ability Six-minute walk: participants are measured to see how far they can walk in 6 minutes. 9. Systolic blood pressure: pressure was taken three times with 5-minute intervals and the average pressure was utilized for comparison. 10. Heart rate variability (HRV): evaluates changes in autonomic tone through 24-hour Holter monitoring, with use of the following indices 26 : Time domain: Mean heart rate in beats per minute SDNN: standard deviation of the normal-to-normal (NN) interval in milliseconds; measures overall HRV SDNN index: the mean of the 5-minute standard deviation of NN intervals calculated over 24 hours; measures overall HRV RMS-SD: the square root of the mean squared differences of successive NN intervals; a measure of vagal tone 24-Hour triangle index: total number of all NN intervals divided by the maximum NN interval; a measure of overall HRV frequency domain Low frequency: variance in the Hz range; a measure of both parasympathetic and sympathetic tone High frequency: variance in the Hz range; a measure of vagal tone 5-Minute total power: variance of all 5-minute intervals; a measure of overall HRV Total power: variance of all NN intervals; a measure of overall HRV RESULTS Data were available for 29 subjects for pre- and posttests. Two treatment group subjects dropped out due to illness and two control subjects lost interest in the study and did not complete the post-tests. The subjects who were not available for post-testing were not significantly different from the other subjects. The SPSS (version 9) (SPSS Inc., Chicago, IL) general linear model was used to evaluate changes in all dependent variables between the control and treatment groups over time. The results of the psychosocial, functional capacity, and blood pressure recordings are reported in Table I. The quality of the 24-hour Holter recordings was good and the participants complied without fail with the monitoring. However, autonomic balance could be evaluated in only 23 of the 29 participants both FALL 2002 PREVENTIVE CARDIOLOGY 171 pre- and post-test, due to excessive ectopic activity in six patients: four of the patients had atrial fibrillation, one had sinus arrhythmia, and one had an excessive number of ectopic ventricular beats. The results of the HRV monitoring are reported in Table II. On measures of psychosocial functioning, significant improvement in the treatment group was noted on the Geriatric Depression Scale (p 0.02), Perceived Stress Scale (p 0.001), and the Medical Outcome Survey question 9 that evaluated emotional status (p 0.001). On the Life Orientation Test, State Trait Anxiety Scale, Medical Outcome Survey question 3, Minnesota Living with Heart Failure, and the Physical Fitness Scale, positive trends were noted. On a measure of functional capacity the 6-minute walk significant improvement was observed (p 0.02). Treatment group members walked, on average, 175 feet further at post-test than at pretest. No change was seen in systolic blood pressure. No significant treatment-associated changes occurred in HRV. There was a slight increase in SDNN and the SDNN index in the treatment group, coupled with slight decreases in SDNN and the SDNN index in the control group. This same trend was noted in RMS-SD, mean heart rate, low frequency variance as well as total power and 5- min total power. No change was seen in 24-hour triangle index for the treatment subjects, while a slight decrease was seen in the control group. The same pattern appeared for high frequency variance. DISCUSSION This controlled pilot study was the authors second attempt to investigate stress management training in patients with CHF. It was successful in that participants regularly attended the training, complied with the assessments and reported that the training was both enjoyable and valuable. The treatment group members were able to significantly reduce their stress levels and improve their ability to cope with stress over the course of the training. They made improvement in physical fitness as evidenced by the increase in distance walked during a 6-minute walk test. In addition, they significantly reduced their level of depression and emotional upset and had positive trends in optimism and CHF disease impact. There were minimal changes in the HRV data, yet most of the indices showed nominal changes in a positive direction for the treatment group and nominal changes in a negative direction for the control group. These results suggest that a longer intervention (9 months to a year) with greater time spent in practice (1 hour per day), and investigated with a larger subject pool might show beneficial changes in autonomic balance. Of note is the response of the patients to the training. Attendance was excellent and in post-test debriefings the participants expressed singular appreciation for the training. Most of them mentioned the lack of psychosocial support they experienced for their condition and their frustration at the number of drugs required for medical management. The authors wish to emphasize the need for further investigation of stress management for patients with CHF. As stated, a dearth of information exists in this area as compared to the substantial research that exists for patients with coronary artery disease. This pilot study showed that these patients make good Table I. Means and Standard Deviations of Dependent Variables at Pre- and Post-Test TREATMENT GROUP CONTROL GROUP P VALUE* N=14 N=15 PRE POST PRE POST (SD) (SD) (SD) (SD) Depression 8.3 (6.0) 5.5 (3.0) 5.3 (6.3) 6.0 (6.8) 0.02 Stress 25.8 (4.6) 20.2 (5.6) 19.1 (8.9) 20.5 (10.3) Optimism 21.1 (3.6) 22.2 (4.0) 25.0 (4.2) 24.5 (4.7) Anxiety 40.2 (8.0) 35.9 (7.1) 36.4 (9.9) 36.6 (11.1) MOS 36-Q (5.6) 23.7 (5.4) 20.4 (5.1) 19.8 (5.5) MOS 36-Q (3.5) 18.8 (4.1) 22.6 (6.9) 22.8 (6.0) MLHF 30.9 (20.5) 23.5 (14.8) 36.9 (22.2) 35.4 (21.8) PF 24.8 (7.1) 23.8 (4.2) 24.5 (6.4) 24.6 (5.9) 6-Minute walk (360) (318) (238) (277) 0.02 Systolic BP (mm Hg) (13.5) (17.0) (20.0) (21.2) *p for difference in the change pre- to post-test between the treatment and control groups; Depression=Geriatric Depression Scale; Stress=Perceived Stress Scale; Optimism=Life Orientation Test; Anxiety=State Trait Anxiety Scale; MOS 36-Q3=Medical Outcome Survey Question 3 Basic Activities; MOS 36-Q9=Medical Outcome Survey Question 9 Emotional Distress; MLHF=Minnesota Living with Heart Failure; PF=perceived physical fitness; 6-Minute walk=distance covered in 6 minutes measured in feet; BP=blood pressure 172 Table II. Measures of Heart Rate Variability at Pre- and Post-Tes
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