CLINICAL TRIAL OF COPING EFFECTIVENESS TRAINING

University Of California San Francisco, San Francisco CA

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Abstract

DESCRIPTION: The proposed study is a randomized clinical trial of a coping effectiveness training (CET) program designed to help HIV-infected persons cope with stress over the course of the progressive disease. The program is based on recent advances in stress and coping theory. The study is designed to address five specific aims. 1. evaluate the effect of CET on the ability of HIV-infected men to decrease psychological distress and increase psychological well-being. 2. Compare the efficacy of two alternative CET maintenance programs to sustain treatment effects over 12 months. 3. Determine the extent to which improvements in distress and well-being are associated with changes in adherence to medical care. 4. Identify the potential psychological and social mechanisms by which CET affects psychological and adherence outcomes. 5. Examine the cost effectiveness of CET by evaluating its effects on health care utilization and health care costs. The evaluation design involves comparing the effects of CET in a trial in which 300 HIV- infected men are randomly assigned to one of three groups, CET plus enhanced maintenance (CET-E), CET plus standard maintenance (CET-S), and a minimal contact control. (MCC). Immediately after the 3-month intervention phase, and at 6 and 12-month follow-up, the effects of CET and the two maintenance strategies will be assessed using measures of psychological distress and well-being, adherence to medical care, and costs.