Clinical trial NCT00600561: Mindfulness Meditation Training in HIV
Official title: Biobehavioral Effects of Mindfulness-Based Stress Reduction in HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: meditation
mindfulness
HIV
CD4
Complementary Therapies
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2008-01-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: CD4+ T lymphocytes (counts)
timeFrame: Pre-test and post-test
Secondary outcomes:
measure: HIV-related Quality of Life
timeFrame: Pre-test and post-test
measure: HIV viral load
timeFrame: Pre-test and post-test
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cousins Center for Psychoneuroimmunology, UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Hector F Myers, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cousins Center for Psychoneuroimmunology, UCLA
name: J. David Creswell, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.