Mindfulness Meditation Training in HIV - Full Text View

Sponsor:	University of California, Los Angeles
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00600561

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Biobehavioral Effects of Mindfulness-Based Stress Reduction in HIV

Resource links provided by NLM:

MedlinePlus related topics: 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
1-Day MBSR: Active Comparator One-day condensed MBSR class	Behavioral: MBSR Mindfulness-Based Stress Reduction Intervention
8-week MBSR: Experimental 8-week Mindfulness-Based Stress Reduction Intervention	Behavioral: MBSR Mindfulness-Based Stress Reduction Intervention

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
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

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:

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2008 Jul 19.

Responsible Party:	UCLA Department of Psychology ( Hector F. Myers, PhD )
Study ID Numbers:	MBSR-HIV-Trial-Seedgrant, M01-RR00865
Study First Received:	January 14, 2008
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00600561 History of Changes
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:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 04, 2010