Mindfulness Meditation Training in HIV

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether Mindfulness-Based Stress Reduction (MBSR) vs a one-day MBSR seminar improves immune (CD4+ T lymphocytes) and virological (HIV viral load) status in HIV-1 infected adults. The secondary goal of the study is to determine if MBSR vs a one-day MBSR seminar improves self-reported HIV-related quality of life.

Detailed Description
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Mindfulness meditation, which is described as a process of bringing awareness to moment-to-moment experience, has been receiving substantial scientific attention as a process that can be stress and health protective (Brown, Ryan, & Creswell, 2007). Recent reviews by Baer (2003), Bishop (2002), and Grossman et al (2004) support the effectiveness of the standardized and manualized MBSR program in reducing stress and functional disability in a variety of chronic illnesses, although no studies have tested if MBSR impacts clinical markers of HIV, although some evidence suggests that MBSR improves some markers of innate immunity and quality of life in HIV-infected adults (see Robinson, Mathews, & Witek-Janusek, 2003). In this study, we propose to extend this work by investigating the impact of this intervention on biological and functional health status in HIV-positive adults. We propose to determine whether the 8-week MBSR program is more effective than a one-day MBSR seminar in: (1) maintaining immune resistance in HIV infection (i.e. maintaining counts of CD4+ T lymphocytes and reducing HIV viral load), and (2) improving HIV-related quality of life. Additional analyses will test for a dose-response effect of MBSR by examining if MBSR class attendance and daily meditation practice are associated with the primary and secondary outcomes. These aims will be tested in a sample of 50 HIV-positive adults that is diverse with respect to ethnicity, gender and sexual orientation.

Official Title
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Biobehavioral Effects of Mindfulness-Based Stress Reduction in HIV

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: MBSR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed HIV for > 6 months English speaking 18 years old or older Indicate some distress (>4 on the Patient Health Questionnaire-9) Willing to be randomized Exclusion Criteria: Any substance abuse or treatment for a psychiatric disorder in the past 30 days Currently diagnosed with AIDS or had CD4+ T lymphocytes <200 cells Hepatitis (A, B, or C) Indicate a regular mind-body practice (e.g., yoga, meditation) in the past six months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1-Day MBSR<br>One-day condensed MBSR class | Behavioral: MBSR<br>* Mindfulness-Based Stress Reduction Intervention<br>* Other names: attention training;|
| Experimental: 8-week MBSR<br>8-week Mindfulness-Based Stress Reduction Intervention | Behavioral: MBSR<br>* Mindfulness-Based Stress Reduction Intervention<br>* Other names: attention training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4+ T lymphocytes (counts) |  | Pre-test and post-test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV-related Quality of Life |  | Pre-test and post-test | 
| HIV viral load |  | Pre-test and post-test | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meditation, mindfulness, HIV, CD4, Complementary Therapies