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Staying Well: A Clinical Trial of Mindfulness-Based Stress Reduction and Education Groups for HIV

2014-07-24 14:26:02 | BioPortfolio

Summary

To examine the effects of Mindfulness-Based Stress Reduction and education groups on HIV infection. Key outcomes include CD4 and viral load, stress hormones, depression and quality of life.

Description

Stress and depression are associated with more rapid loss of CD4 cells in HIV infection. Interventions that slow the advance of HIV infection and delay the introduction of antiretroviral therapy (ART) could make an important contribution to HIV management in both the developed and developing world. We are conducting a 330 person randomized, controlled clinical trial of MBSR for persons with HIV-1 infection and CD4 T-lymphocyte counts > 250 cells/µm who are not on antiretroviral therapy. Participants are randomized in a 1:1 distribution to either the MBSR intervention or to an education group that will control for the attention and social interaction aspects of MBSR. Participants are evaluated at 0, 3, 6 and 12 months. Key outcome measures at 12 months include differences in CD4 T cell counts, HIV viral load, perceived stress, depression, and positive affect. We are also examining whether MBSR is associated with changes in neuroendocrine function (autonomic nervous system activity, cortisol secretion) and alterations in immune function that may serve as intermediate steps between the neuroendocrine effects of MBSR and CD4 T cell counts, such as changes in T cell activation. A subset of 90 participants will be studied in additional detail using a structured laboratory stress challenge.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

HIV

Intervention

Mindfulness-Based Stress Reduction (MBSR), HIV-education and self-management workshop

Location

Osher Center for Integrative Medicine
San Francisco
California
United States
94143-1726

Status

Active, not recruiting

Source

National Center for Complementary and Alternative Medicine (NCCAM)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:26:02-0400

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