Project 1 - A Clinical Trial of Mindfulness Based Stress Reduction in Early HIV

Hecht, Frederick

Abstract

Currently there are no interventions designed specifically for individuals with early stage HIV infection who are not yet on antiretrovial therapy (ART). Interventions that slow the advance of HIV infection and delay the introduction of ART could make a very important contribution to HIV management in both the developed and developing world. There is evidence that stress and depression are associated with more rapid loss of CD4 cells in HIV infection. We therefore plan a 330 person randomized, controlled clinical trial of a meditation based approach to stress reduction and emotion management, mindfulness-based stress reduction (MBSR) for people with early stage (CD4 cells > 350 cells/mu l) HIV disease. MBSR consists of a course of 8 weekly group sessions that provides instruction in mindfulness meditation and yoga postures, aimed at integrating mindfulness into daily life as a means of improving the ability of participants to manage stress and distressing emotions. We selected MBSR because of prior data showing effectiveness in decreasing stress and depression and preliminary data showing that it can improve immune responses in persons with and without HIV. MBSR also has the strength of being unlikely to have important adverse effects. Subjects will be followed for 1 year, with evaluations at baseline, 3 months, 6 months, and 12 months. At the end of 12 months the control group will be offered MBSR. The primary aims of the study are to determine whether the MBSR group will have smaller declines in CD4 T-lymphocyte cell counts, lower HIV RNA levels, higher health related quality of life, and less depression than the control group. We also aim to test whether MBSR reduces other outcomes that have been associated with stress and depression such as frequency of upper respiratory tract infections. Participants in the trial will form the subject pool for detailed studies of stress, neuroendocrine function, and immune function in Projects 2 and 3 of this proposal. The results of the study will address the key question of whether a meditation-based intervention is able to alter the accelerated HIV disease progression associated with stress and depression. It will also extend our understanding of the effects of MBSR on health outcomes such as stress, mood, health related quality of life, and resistance to upper respiratory tract infections, issues that are applicable to a broad range of populations.