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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
  Purpose
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.

Condition Intervention Phase
HIV Infections
 Behavioral: MBSR
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Biobehavioral Effects of Mindfulness-Based Stress Reduction in HIV

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • CD4+ T lymphocytes (counts) [ Time Frame: Pre-test and post-test ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]
Enrollment: 50
Study Start Date: June 2005
Study Completion Date: January 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1-Day MBSR
One-day condensed MBSR class
 Behavioral: MBSR
Mindfulness-Based Stress Reduction Intervention
Other Names:
  • mindfulness meditation
  • attention training
Experimental: 8-week MBSR
8-week Mindfulness-Based Stress Reduction Intervention
 Behavioral: MBSR
Mindfulness-Based Stress Reduction Intervention
Other Names:
  • mindfulness meditation
  • attention training

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.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600561

Locations
United States, California
Cousins Center for Psychoneuroimmunology, UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Hector F Myers, PhD UCLA Department of Psychology
Study Director: J. David Creswell, PhD Cousins Center for Psychoneuroimmunology, UCLA
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hector F. Myers, PhD, UCLA Department of Psychology
ClinicalTrials.gov Identifier: NCT00600561     History of Changes
Other Study ID Numbers: MBSR-HIV-Trial-Seedgrant  M01RR000865 
Study First Received: January 14, 2008
Last Updated: January 14, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
meditation
mindfulness
HIV
CD4
Complementary Therapies

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2016