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

NCT ID: NCT00271856

Last Updated: 2012-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2009-09-30

Brief Summary

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

Detailed 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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

0

Mindfulness Based Stress Reduction (MBSR)

Group Type: EXPERIMENTAL

Mindfulness-Based Stress Reduction (MBSR)

Intervention Type: BEHAVIORAL

8 week MBSR course

1

HIV education/self-management workshop

Group Type: ACTIVE_COMPARATOR

HIV-education and self-management workshop

Intervention Type: BEHAVIORAL

8-week group covering a variety of educational topics about managing HIV infection.

Interventions

Mindfulness-Based Stress Reduction (MBSR)

8 week MBSR course

Intervention Type: BEHAVIORAL

HIV-education and self-management workshop

8-week group covering a variety of educational topics about managing HIV infection.

Intervention Type: BEHAVIORAL

Other Intervention Names

Mindfulness meditation

Eligibility Criteria

Inclusion Criteria

• HIV+
• Viral Load>100
• CD4 T-Cells>250
• Not on Antiretroviral therapy (ART)
• Ability to Speak English
• Stable address/living situation

Exclusion Criteria

• Inability to provide informed consent
• Use of ART within the past 120 days
• Any substance abuse,mental health or medical condition that the opinion of the Principal Investigator (PI) would make it difficult for the potential participant to participate in the intervention
• Plans to start ART in the next 12 months
• Previous MBSR training and/or current practice
• Current use or use in past 6 months (mos.) of chemotherapy or immunomodulator drugs, including oral steroids or plans to start in the next 12 mos.
• Initiation of new class of psychiatric medication in past 2 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederick M. Hecht, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Susan Folkman, PhD

Role: STUDY_DIRECTOR

University of California, San Francisco

Locations

Osher Center for Integrative Medicine

San Francisco, California, United States

Countries

United States

Other Identifiers

P01AT002024

Identifier Type: NIH

Identifier Source: secondary_id

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P01AT002024

Identifier Type: NIH

Identifier Source: org_study_id

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