Mindfulness Meditation Training in HIV

HIV Infections Clinical Trial

— MBSR  

Official title:

Biobehavioral Effects of Mindfulness-Based Stress Reduction in HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600561
• Other study ID #: MBSR-HIV-Trial-Seedgrant
• Secondary ID: M01RR000865
• Status: Completed
• Phase: Phase 2
• First received: January 14, 2008
• Last updated: January 14, 2008
• Start date: June 2005
• Est. completion date: January 2008

Study information

• Verified date: January 2008
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• MBSR
Mindfulness-Based Stress Reduction Intervention

Locations

Country	Name	City	State
United States	Cousins Center for Psychoneuroimmunology, UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD4+ T lymphocytes (counts)		Pre-test and post-test	No
Secondary	HIV-related Quality of Life		Pre-test and post-test	No
Secondary	HIV viral load		Pre-test and post-test	No