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Staying Well: A Clinical Trial of Mindfulness-Based Stress Reduction and Education Groups for HIV
This study is ongoing, but not recruiting participants.
Study NCT00271856   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)
First Received: December 30, 2005   Last Updated: October 7, 2008   History of Changes

December 30, 2005
October 7, 2008
May 2005
July 2009   (final data collection date for primary outcome measure)
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 ]
CD4 T-cell count and HIV viral load at 3, 6 and 12 months; perceived stress (Cohen’s Perceived Stress Scale); depression (Beck Depression Inventory; Prime-MD) and positive affect (PANAS scale).
Complete list of historical versions of study NCT00271856 on ClinicalTrials.gov Archive Site
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 ]
Quality of life (SF-36); cortisol (basil 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)
 
Staying Well: A Clinical Trial of Mindfulness-Based Stress Reduction and Education Groups for HIV
MBSR, Stress Arousal and Immune Response in Early HIV

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.

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.

Phase II
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
HIV
  • Behavioral: Mindfulness-Based Stress Reduction (MBSR)
  • Behavioral: HIV-education and self-management workshop
  • Experimental: Mindfulness Based Stress Reduction (MBSR)
  • Active Comparator: HIV education/self-management workshop
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
200
August 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00271856
Rick Hecht, MD, University of California San Francisco
P01 AT002024
National Center for Complementary and Alternative Medicine (NCCAM)
 
Principal Investigator: Frederick M. Hecht, M.D. University of California, San Francisco
Study Director: Susan Folkman, PhD University of California, San Francisco
National Center for Complementary and Alternative Medicine (NCCAM)
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP