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Staying Well: A Clinical Trial of Mindfulness-Based Stress Reduction and Education Groups for HIV
This study has been completed.

First Received on December 30, 2005.   Last Updated on December 15, 2010   History of Changes
Sponsor: University of California, San Francisco
Collaborator: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00271856
  Purpose

To examine the effects of Mindfulness-Based Stress Reduction and education groups on HIV infection. Key outcomes include CD4 and viral load, stress hormones, depression and quality of life.


Condition Intervention Phase
HIV
Behavioral: Mindfulness-Based Stress Reduction (MBSR)
Behavioral: HIV-education and self-management workshop
Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MBSR, Stress Arousal and Immune Response in Early HIV

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • CD4 T-cell count and HIV viral load ; perceived stress (Cohen's Perceived Stress Scale); depression (Beck Depression Inventory; Prime-MD) and positive affect (PANAS scale). [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life (SF-36); cortisol (basal a.m. and diurnal change); T-cell activation (measured by CD38-cell surface marker) and NK cell number and function; autonomic activity (blood pressure, estimated systemic vascular resistance); cell aging [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2005
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0
Mindfulness Based Stress Reduction (MBSR)
Behavioral: Mindfulness-Based Stress Reduction (MBSR)
8 week MBSR course
Other Name: Mindfulness meditation
Active Comparator: 1
HIV education/self-management workshop
Behavioral: HIV-education and self-management workshop
8-week group covering a variety of educational topics about managing HIV infection.

Detailed Description:

Stress and depression are associated with more rapid loss of CD4 cells in HIV infection. Interventions that slow the advance of HIV infection and delay the introduction of antiretroviral therapy (ART) could make an important contribution to HIV management in both the developed and developing world. We are conducting a 330 person randomized, controlled clinical trial of MBSR for persons with HIV-1 infection and CD4 T-lymphocyte counts > 250 cells/µm who are not on antiretroviral therapy. Participants are randomized in a 1:1 distribution to either the MBSR intervention or to an education group that will control for the attention and social interaction aspects of MBSR. Participants are evaluated at 0, 3, 6 and 12 months. Key outcome measures at 12 months include differences in CD4 T cell counts, HIV viral load, perceived stress, depression, and positive affect. We are also examining whether MBSR is associated with changes in neuroendocrine function (autonomic nervous system activity, cortisol secretion) and alterations in immune function that may serve as intermediate steps between the neuroendocrine effects of MBSR and CD4 T cell counts, such as changes in T cell activation. A subset of 90 participants will be studied in additional detail using a structured laboratory stress challenge.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV+
  • VL>100
  • CD4 T-Cells>250
  • Not on Antiretroviral therapy (ART)
  • Ability to Speak English
  • Stable address/living situation

Exclusion Criteria:

  • Inability to provide informed consent
  • Use of ART within the past 120 days
  • Any substance abuse,mental health or medical condition that the opinion of the PI would make it difficult for the potential participant to participate in the intervention
  • Plans to start ART in the next 12 months
  • Previous MBSR training and/or current practice
  • Current use or use in past 6 mos. of chemotherapy or immunomodulator drugs, including oral steroids or plans to start in the next 12 mos.
  • Initiation of new class of psychiatric medication in past 2 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271856

Locations
United States, California
Osher Center for Integrative Medicine
San Francisco, California, United States, 94143-1726
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Frederick M. Hecht, M.D. University of California, San Francisco
Study Director: Susan Folkman, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Rick Hecht, MD, University of California San Francisco
ClinicalTrials.gov Identifier: NCT00271856     History of Changes
Other Study ID Numbers: P01 AT002024, P01AT002024
Study First Received: December 30, 2005
Last Updated: December 15, 2010
Health Authority: United States: Federal Government

Keywords provided by University of California, San Francisco:
HIV
Meditation
Stress
Randomized Controlled Trial
Complementary Therapies
MBSR
Not on ART medications

ClinicalTrials.gov processed this record on February 09, 2012