Mindfulness Meditation Training in HIV (MBSR)

• ClinicalTrials.gov Identifier: NCT00600561
• Recruitment Status: Completed
• First Posted: January 25, 2008
• Last Update Posted: January 25, 2008
• Sponsor: University of California, Los Angeles
• Information provided by: University of California, Los Angeles

Tracking Information

• First Submitted Date: January 14, 2008
• First Posted Date: January 25, 2008
• Last Update Posted Date: January 25, 2008
• Study Start Date: June 2005
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 14, 2008): CD4+ T lymphocytes (counts) [ Time Frame: Pre-test and post-test ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mindfulness Meditation Training in HIV
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: HIV Infections

Intervention

Behavioral: MBSR

Mindfulness-Based Stress Reduction Intervention

Other Names:

• mindfulness meditation
• attention training

Study Arms

• 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 *

• Hinkin CH, Barclay TR, Castellon SA, Levine AJ, Durvasula RS, Marion SD, Myers HF, Longshore D. Drug use and medication adherence among HIV-1 infected individuals. AIDS Behav. 2007 Mar;11(2):185-94.
• Creswell JD, Way BM, Eisenberger NI, Lieberman MD. Neural correlates of dispositional mindfulness during affect labeling. Psychosom Med. 2007 Jul-Aug;69(6):560-5. Epub 2007 Jul 18.
• Creswell JD, Myers HF, Cole SW, Irwin MR. Mindfulness meditation training effects on CD4+ T lymphocytes in HIV-1 infected adults: a small randomized controlled trial. Brain Behav Immun. 2009 Feb;23(2):184-8. doi: 10.1016/j.bbi.2008.07.004. Epub 2008 Jul 19.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 14, 2008): 50
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 2008
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00600561
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Hector F. Myers, PhD, UCLA Department of Psychology
• Study Sponsor: University of California, Los Angeles
• Collaborators: Not Provided

Investigators

• 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