Clinical trial NCT00271856: Staying Well: A Clinical Trial of Mindfulness-Based Stress Reduction and Education Groups for HIV
Official title: Mindfulness-Based Stress Reduction (MBSR), Stress Arousal and Immune Response in Early HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
Keywords: HIV
Meditation
Stress
Randomized Controlled Trial
Complementary Therapies
MBSR
Not on ART medications
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2006-01-04
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in CD4 T-cell Count
timeFrame: baseline to 12 months
measure: Change in Depression as Measured by Beck Depression Inventory (BDI)
timeFrame: baseline to 12 months
measure: Change in Perceived Stress as Measured by Perceived Stress Scale (PSS)
timeFrame: baseline to 12 months
measure: Change in Positive and Negative Affect (PANAS) Positive Affect (PA) Score
timeFrame: baseline to 12 months
measure: Change in Positive and Negative Affect Scale (PANAS) Negative Affect (NA) Score
timeFrame: baseline to 12 months
measure: Change in Depression as Measured by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: baseline to 12 months
Secondary outcomes:
measure: Quality of Life (Short Form Health Survey; SF-36); Cortisol (Basal a.m. and Diurnal Change); T-cell Activation (i.e. CD38-cell Surface Marker) and NK Cell Number and Function; Autonomic Nervous System Activity ; Cell Aging
timeFrame: 3, 6, and 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Osher Center for Integrative Medicine
state: California
Study officials:
affiliation: University of California, San Francisco
name: Frederick M. Hecht, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Susan Folkman, PhD
role: STUDY_DIRECTOR
References: