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

University of California San Francisco (UCSF)

Status and phase

Completed

Phase 2

Conditions

HIV

Treatments

Behavioral: HIV-education and self-management workshop

Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00271856

P01AT002024 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

177 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.