Mindfulness Meditation Training in HIV

Phase 2

Completed

• Conditions: HIV Infections
• Interventions: Behavioral: MBSR

• Registration Number: NCT00600561
• Lead Sponsor: University of California, Los Angeles

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2007-12
• Status Verified: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2008-01-14
• Study First Submitted QC: 2008-01-14
• Last Update Submitted: 2008-01-14
• Study First Posted: 2008-01-25
• Last Update Posted: 2008-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1-Day MBSR	MBSR	One-day condensed MBSR class
8-week MBSR	MBSR	8-week Mindfulness-Based Stress Reduction Intervention

Primary Outcome Measures

Name	Time	Method
CD4+ T lymphocytes (counts)	Pre-test and post-test

Secondary Outcome Measures

Name	Time	Method
HIV-related Quality of Life	Pre-test and post-test
HIV viral load	Pre-test and post-test

Trial Locations

Locations (1)

Cousins Center for Psychoneuroimmunology, UCLA; 🇺🇸 Los Angeles, California, United States