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Mindfulness Meditation Training in HIV (MBSR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00600561
Recruitment Status : Completed
First Posted : January 25, 2008
Last Update Posted : January 25, 2008
Sponsor:
Information provided by:
University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE January 14, 2008
First Posted Date  ICMJE January 25, 2008
Last Update Posted Date January 25, 2008
Study Start Date  ICMJE June 2005
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2008)
CD4+ T lymphocytes (counts) [ Time Frame: Pre-test and post-test ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2008)
  • HIV-related Quality of Life [ Time Frame: Pre-test and post-test ]
  • HIV viral load [ Time Frame: Pre-test and post-test ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindfulness Meditation Training in HIV
Official Title  ICMJE Biobehavioral Effects of Mindfulness-Based Stress Reduction in HIV
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE Behavioral: MBSR
Mindfulness-Based Stress Reduction Intervention
Other Names:
  • mindfulness meditation
  • attention training
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2008)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00600561
Other Study ID Numbers  ICMJE MBSR-HIV-Trial-Seedgrant
M01RR000865 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hector F. Myers, PhD, UCLA Department of Psychology
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hector F Myers, PhD UCLA Department of Psychology
Study Director: J. David Creswell, PhD Cousins Center for Psychoneuroimmunology, UCLA
PRS Account University of California, Los Angeles
Verification Date January 2008

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