Psychosocial Behavioral Interventions with Acute Coronary Syndrome Patients

Several meta-analyses have examined randomized psychosocial-behavioral interventions in patients with CHD (Clark et al, 2005; Dusseldorp et al, 1999; Linden et al, 1996, 2007). Most of the studies that were analyzed compared a psychosocial-behavioral intervention with usual care. The meta-analysis by Dusseldorp and colleagues examined the effects of health education and stress management in 37 studies and found a 34% reduction in cardiovascular mortality, a 29% reduction in MI recurrence and significant positive effects for blood pressure, cholesterol, body weight, smoking, physical exercise, and eating habits.

Cardiac rehabilitation programs that were successful in improving traditional risk factor profiles were also more effective in decreasing cardiovascular mortality and MI recurrence than those that were not successful in risk factor reduction.

Linden et al (1996) conducted a meta-analysis on 3,180 CHD patients in 23 randomized controlled trials (RCTs) and found that patients who did not receive psychosocial-behavioral treatment showed greater mortality (0R=1.70; 95% confidence interval [CI], 1.09-2.64) and MI recurrence (0R=1.84; CI, 1.12-2.99) than those who did. Similarly, Clark et al (2005) conducted a meta-analysis on 21,295 CHD patients in 63 RCTs and reported an 0R=0.85; CI, 0.770.94 for all-cause mortality and 0R=0.83; CI, 0.74-0.94 for recurrent MI. More recently in a meta-analysis conducted on 9,856 CHD patients in 43 RCTs, Linden et al (2007) found that trials initiating treatment at least 2 months after a cardiovascular event revealed greater mortality savings than those beginning treatment sooner (0R=0.28; CI, 0.11-0.70 vs 0R=0.87, CI, 0.86-1.15, respectively). Moreover the mortality benefits applied only to men (0R=0.73; CI, 0.57-1.00) but not to women (0R=1.01, CI, 0.87-1.72). In general then, meta-analyses have confirmed that psychosocial-behavioral interventions in MI patients can improve cardiovascular risk factor profiles, decrease mortality, and reduce recurrent MI. Beneficial effects appear to be more likely if the intervention begins at least 2 months after the MI and are more likely in men than in women. Although meta-analyses are useful in providing a broad overview of outcomes in a research area, it is important to examine key RCT in order to assess the quality of the data and to begin to understand differences and similarities in outcomes.

Among the psychosocial-behavioral RCTs that have been conducted upon post-MI patients, there have been exceptionally few large-scale trials that meet the reporting criteria of the Consolidated Standards of Reporting Trials (C0NS0RT) statement (Moher et al, 2001). The few trials that have approximated these standards have yielded both positive and null results. Because of the heterogeneity of the procedures employed, the exact reasons for the discrepancies in results have not been entirely obvious.

The Recurrent Coronary Prevention Project (RCPP) randomized 862 post-MI patients (90% men; 98% white) into either a control condition receiving group-based traditional risk factor counseling (diet, exercise, medication adherence) or an intervention condition receiving group-based risk factor counseling plus cognitive behavior therapy (CBT) to reduce type A behaviors (i.e., hostility, impatience, time urgency) and relaxation training to decrease behavioral arousal (Friedman et al, 1986). Patients were enrolled at least 6 months after their MI. The average control participant attended 25 (76% of total available) sessions and the average intervention participant attended 38 (61% of total available) sessions over 4.5 years. Rate of combined fatal and nonfatal recurrence was significantly lower in the intervention than in the control group. Participants in the intervention group also showed significant decreases in hostility, time urgency, impatience, and depressed mood as well as reliable gains in perceived self-efficacy (Mendes de Leon et al, 1991).

In a subsequent RCT, Jones and West (1996) randomized 2,328 post-MI patients into either an intervention condition receiving seven weekly psychological counseling and therapy, relaxation, and stress management sessions (some in a group format) or a usual care condition. Other components of rehabilitation dealing with smoking, diet, weight control, or exercise were not included in the program. Patients were enrolled within 28 days after their MI. Data on the age, sex distribution, or racial/ethnicity of participants are not described in the published article. The investigators found no significant differences within or between groups in reported anxiety and depression between baseline and 6 months and no differences between conditions in clinical complications, clinical sequaelae, or mortality after 1 year.

The Montreal Heart Attack Readjustment Trial (M-HART) was an RCT carried out in 1,376 post-MI patients assigned to an intervention or control condition (Frasure-Smith et al, 1997). Intervention participants were telephoned by a research assistant 1 week after discharge, then monthly for a year. They responded to the 20-item general health questionnaire (Goldberg, 1972), which assesses psychological distress from anxiety, depressed mood, and activity impairment. Participants scoring 5 or higher on the questionnaire or were readmitted to the hospital were then contacted by a cardiology nurse who made a home visit and provided reassurance, education, practical advice, and when necessary referral to a health-care provider. Nurses were not given specific training for implementing the protocol beyond their cardiology nursing training. About 75% of patients in the intervention condition received on average 5-6 1-h nursing visits. In general, the program had no overall impact upon either cardiac or all-cause mortality or on psychological outcomes (depressive symptoms, anxiety, anger, or perceived social support) between intervention and control groups. However, treated women did reveal marginally greater all-cause mortality than control women (OR=1.99; CI, 0.99-4.00) suggesting that the intervention may actually have been harmful to women. The OR for cardiac mortality was 1.96 (CI, 0.95-4.06).

Subsequently, the enhancing Recovery in Coronary Heart Disease (ENRICHD) trial randomized 2,481 post-MI patients (44% women; 34% ethnic minority), selected because they were depressed and/or had low social support, into a CBT-based psychosocial-behavioral intervention or to usual medical care (Berkman et al, 2003). The intervention was initiated at a median of 17 days after MI for a median of 11 individual sessions throughout 6 months. During this 6-month period 30% of participants also received group-based CBT and relaxation training and were placed on a selective serotonin reuptake inhibitor if they had severe depression or less than 50% reduction in Beck's depression inventory scores after 5 weeks of intervention.

By 6 months after randomization ENRICHD modestly decreased depression and increased social support in the intervention compared with the control group. However, after an average follow-up of 29 months, there was no significant difference in event-free survival between the usual care and the psychosocial intervention conditions. Because ENRICHD was designed to enroll large numbers of women and minorities, it was possible to conduct a secondary analysis examining the outcome of sex by ethnicity subgroups (Schneiderman et al, 2004). This secondary analysis indicated that the intervention decreased the incidence of both cardiac death (OR=0.63; CI, 0.40-0.99) and nonfatal MI (or=0.61; CI, 0.40-0.92) in white men but not in the other subgroups.

Most recently, the Stockholm Women's Intervention Trial for Coronary Heart Disease (SWITCHD) randomized 237 patients with severe CHD incidents into a group-based psychosocial-behavioral intervention program or usual medical care (Orth-Gomer et al, 2009). Initiated 4 months after hospitalization, intervention groups of 4-8 women met for a total of 20 sessions over the course of an entire year. The intervention program, in which 75% of the women attended 15-20 sessions, included education about risk factors, self-care, and adherence to medical advice, as well as skills training in relaxation and coping with stress exposure from family and work. The nurses who delivered the intervention were pre-trained and certified in the behavior modification techniques used in the trial. From randomization until the end of follow-up (mean duration 7.1 years), the intervention yielded an almost threefold protective effect on mortality rate (OR=0.33; CI, 0.1-0.74).

The meta-analyses that have been conducted on psychosocial-behavioral interventions in patients with severe CHD-related events indicate that such treatments can reduce the incidence of nonfatal and/or fatal events. Examination of major studies carried out on such patients reveals that the studies reporting positive results were initiated several months after the index event, used a group-based format, conducted the intervention for a relatively long temporal duration, and followed the patients for a number of years (Friedman et al, 1986; Orth-Gomer et al, 2009). These trials addressed a broad range of modifiable traditional and psychosocial risk factors, medication adherence, and lifestyle adjustment as well as provided training in behavior change methods by group leaders who themselves were certified in such procedures. Some of the conclusions drawn from these trials are based on post hoc analyses and reviews of trial data, so prospective replication studies are needed.

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