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Mindfulness Meditation Training in HIV (MBSR)

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MBSR
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring meditation, mindfulness, HIV, CD4, Complementary Therapies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cousins Center for Psychoneuroimmunology, UCLA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1-Day MBSR

8-week MBSR

Arm Description

One-day condensed MBSR class

8-week Mindfulness-Based Stress Reduction Intervention

Outcomes

Primary Outcome Measures

CD4+ T lymphocytes (counts)

Secondary Outcome Measures

HIV-related Quality of Life
HIV viral load

Full Information

First Posted
January 14, 2008
Last Updated
January 14, 2008
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT00600561
Brief Title
Mindfulness Meditation Training in HIV
Acronym
MBSR
Official Title
Biobehavioral Effects of Mindfulness-Based Stress Reduction in HIV
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
meditation, mindfulness, HIV, CD4, Complementary Therapies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1-Day MBSR
Arm Type
Active Comparator
Arm Description
One-day condensed MBSR class
Arm Title
8-week MBSR
Arm Type
Experimental
Arm Description
8-week Mindfulness-Based Stress Reduction Intervention
Intervention Type
Behavioral
Intervention Name(s)
MBSR
Other Intervention Name(s)
mindfulness meditation, attention training
Intervention Description
Mindfulness-Based Stress Reduction Intervention
Primary Outcome Measure Information:
Title
CD4+ T lymphocytes (counts)
Time Frame
Pre-test and post-test
Secondary Outcome Measure Information:
Title
HIV-related Quality of Life
Time Frame
Pre-test and post-test
Title
HIV viral load
Time Frame
Pre-test and post-test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hector F Myers, PhD
Organizational Affiliation
UCLA Department of Psychology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J. David Creswell, PhD
Organizational Affiliation
Cousins Center for Psychoneuroimmunology, UCLA
Official's Role
Study Director
Facility Information:
Facility Name
Cousins Center for Psychoneuroimmunology, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16897351
Citation
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. doi: 10.1007/s10461-006-9152-0.
Results Reference
background
PubMed Identifier
17634566
Citation
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. doi: 10.1097/PSY.0b013e3180f6171f. Epub 2007 Jul 18.
Results Reference
background
PubMed Identifier
18678242
Citation
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.
Results Reference
derived

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Mindfulness Meditation Training in HIV

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