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Completed

NCT Number: NCT00600561

Mindfulness Meditation Training in HIV

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cousins Center for Psychoneuroimmunology, UCLA

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBSR

Behavioral

Mindfulness-Based Stress Reduction Intervention

Other names: mindfulness meditation, attention training

Primary outcomes

  1. CD4+ T lymphocytes (counts)

    Time frame: Pre-test and post-test

Secondary outcomes

  1. HIV-related Quality of Life

    Time frame: Pre-test and post-test

  2. HIV viral load

    Time frame: Pre-test and post-test

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

Biobehavioral Effects of Mindfulness-Based Stress Reduction in HIV

Acronym: MBSR

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Jan 25, 2008
Registry last updated
Jan 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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