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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00271856 |
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.
Condition | Intervention | Phase |
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HIV |
Behavioral: Mindfulness-Based Stress Reduction (MBSR) Behavioral: HIV-education and self-management workshop |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | MBSR, Stress Arousal and Immune Response in Early HIV |
Estimated Enrollment: | 200 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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0: Experimental
Mindfulness Based Stress Reduction (MBSR)
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Behavioral: Mindfulness-Based Stress Reduction (MBSR)
8 week MBSR course
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1: Active Comparator
HIV education/self-management workshop
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Behavioral: HIV-education and self-management workshop
8-week group covering a variety of educational topics about managing HIV infection.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Osher Center for Integrative Medicine | |
San Francisco, California, United States, 94143-1726 |
Principal Investigator: | Frederick M. Hecht, M.D. | University of California, San Francisco |
Study Director: | Susan Folkman, PhD | University of California, San Francisco |
Responsible Party: | University of California San Francisco ( Rick Hecht, MD ) |
Study ID Numbers: | P01 AT002024 |
Study First Received: | December 30, 2005 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00271856 |
Health Authority: | United States: Federal Government |
HIV Meditation Stress Randomized Controlled Trial |
Complementary Therapies MBSR Not on ART medications |
HIV Infections Acquired Immunodeficiency Syndrome Stress |