Mindfulness Meditation Training in HIV (MBSR)

This study has been completed.
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00600561
First received: January 14, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted

January 14, 2008
January 14, 2008
June 2005
December 2007   (final data collection date for primary outcome measure)
CD4+ T lymphocytes (counts) [ Time Frame: Pre-test and post-test ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • HIV-related Quality of Life [ Time Frame: Pre-test and post-test ] [ Designated as safety issue: No ]
  • HIV viral load [ Time Frame: Pre-test and post-test ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Mindfulness Meditation Training in HIV
Biobehavioral Effects of Mindfulness-Based Stress Reduction in HIV

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
Behavioral: MBSR
Mindfulness-Based Stress Reduction Intervention
Other Names:
  • mindfulness meditation
  • attention training
  • Active Comparator: 1-Day MBSR
    One-day condensed MBSR class
    Intervention: Behavioral: MBSR
  • Experimental: 8-week MBSR
    8-week Mindfulness-Based Stress Reduction Intervention
    Intervention: Behavioral: MBSR

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2008
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00600561
MBSR-HIV-Trial-Seedgrant, M01-RR00865
No
Hector F. Myers, PhD, UCLA Department of Psychology
University of California, Los Angeles
Not Provided
Principal Investigator: Hector F Myers, PhD UCLA Department of Psychology
Study Director: J. David Creswell, PhD Cousins Center for Psychoneuroimmunology, UCLA
University of California, Los Angeles
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP