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Stress management for patients with heart disease: a pilot study
Turner L, Linden W, van der Wal R, Schamberger W
Heart & Lung 1995 Mar-Apr;24(2):145-153
clinical trial
3/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: No; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To conduct a feasibility study on stress management for patients with heart disease; more specifically, to test the availability of patients, determine dropout rates, and investigate the sensitivity to change of a large number of psychologic and biologic stress indexes. DESIGN: Random assignment, two-group clinical trial. SETTING: Pacific Northwest university-affiliated teaching hospital. PATIENTS: Forty-five patients with heart disease (mean age 56 years), who either had a myocardial infarction or coronary bypass surgery. OUTCOME MEASURES: Hostility, subjective distress, resting electrocardiogram, resting blood pressure and blood pressure reactivity to a psychologic stressor, and blood lipid, cortisol, and catecholamine levels. INTERVENTION: Patients were randomly assigned to either (1) exercise rehabilitation (ER) and an 8-week stress management (SM) program (ER+SM) or (2) ER only. Although the recruitment rate was satisfactory, 67% of patients assigned to the control condition and 40% of the SM subjects were not available for posttesting. RESULTS: Computed effect sizes indicated that blood pressure reactivity to a psychologic challenge was reduced after treatment in the ER+SM group but not in ER group. The ER+SM group showed improvement in perceived health status and had clinically meaningful reductions in triglyceride levels, whereas the ER group did not. The ER group had a reduction in high-density lipoproteins, whereas the high-density lipoprotein levels of the ER+SM group did not change. CONCLUSIONS: Patients randomly assigned to a control condition may be less willing to participate in time-consuming and invasive posttests than treated patients. Reducing the invasiveness of measurement may increase cost-effectiveness and reduce the dropout rate under controlled conditions. Blood pressure reactivity to a psychologic stress test and changes in serum lipid levels may be sensitive and cost-effective measures to include in future studies of cardiac rehabilitation.

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