NCT00600561

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 25, 2008

Completed
Last Updated

January 25, 2008

Status Verified

January 1, 2008

Enrollment Period

2.5 years

First QC Date

January 14, 2008

Last Update Submit

January 14, 2008

Conditions

Keywords

meditationmindfulnessHIVCD4Complementary Therapies

Outcome Measures

Primary Outcomes (1)

  • CD4+ T lymphocytes (counts)

    Pre-test and post-test

Secondary Outcomes (2)

  • HIV-related Quality of Life

    Pre-test and post-test

  • HIV viral load

    Pre-test and post-test

Study Arms (2)

1-Day MBSR

ACTIVE COMPARATOR

One-day condensed MBSR class

Behavioral: MBSR

8-week MBSR

EXPERIMENTAL

8-week Mindfulness-Based Stress Reduction Intervention

Behavioral: MBSR

Interventions

MBSRBEHAVIORAL

Mindfulness-Based Stress Reduction Intervention

Also known as: mindfulness meditation, attention training
1-Day MBSR8-week MBSR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed HIV for \> 6 months
  • English speaking
  • years old or older
  • Indicate some distress (\>4 on the Patient Health Questionnaire-9)
  • Willing to be randomized

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cousins Center for Psychoneuroimmunology, UCLA

Los Angeles, California, 90095, United States

Location

Related Publications (3)

  • 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.

    PMID: 16897351BACKGROUND
  • 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.

    PMID: 17634566BACKGROUND
  • 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.

MeSH Terms

Conditions

HIV Infections

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Hector F Myers, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR
  • J. David Creswell, PhD

    Cousins Center for Psychoneuroimmunology, UCLA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 14, 2008

First Posted

January 25, 2008

Study Start

June 1, 2005

Primary Completion

December 1, 2007

Study Completion

January 1, 2008

Last Updated

January 25, 2008

Record last verified: 2008-01

Locations