Staying Well: A Clinical Trial of Mindfulness-Based Stress Reduction and Education Groups for HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00271856
Recruitment Status : Completed
First Posted : January 4, 2006
Results First Posted : March 6, 2012
Last Update Posted : April 17, 2012
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of California, San Francisco

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV
Interventions: Behavioral: Mindfulness-Based Stress Reduction (MBSR)
Behavioral: HIV-education and self-management workshop

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited between July 2005 to August 2008 through newspaper advertisements, electronic bulletin boards, community postings and fliers in clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolled participants were screened to determine if inclusion criteria were met. This process included structured phone interviews, medical history review, and laboratory results.

Reporting Groups
0 Mindfulness-Based Stress Reduction (MBSR) Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
1-HIV Education/Self-management HIV education/self-management workshop: 8 weekly classes.

Participant Flow:   Overall Study
    0 Mindfulness-Based Stress Reduction (MBSR)   1-HIV Education/Self-management
STARTED   89   88 
COMPLETED   78   70 
NOT COMPLETED   11   18 
Withdrawal by Subject                1                7 
Lost to Follow-up                10                11 

  Baseline Characteristics

  Outcome Measures

1.  Primary:   Change in CD4 T-cell Count   [ Time Frame: baseline to 12 months ]

2.  Primary:   Change in Depression as Measured by Beck Depression Inventory (BDI)   [ Time Frame: baseline to 12 months ]

3.  Primary:   Change in Perceived Stress as Measured by Perceived Stress Scale (PSS)   [ Time Frame: baseline to 12 months ]

4.  Primary:   Change in Positive and Negative Affect (PANAS) Positive Affect (PA) Score   [ Time Frame: baseline to 12 months ]

5.  Primary:   Change in Positive and Negative Affect Scale (PANAS) Negative Affect (NA) Score   [ Time Frame: baseline to 12 months ]

6.  Primary:   Change in Depression as Measured by the Patient Health Questionnaire-9 (PHQ-9)   [ Time Frame: baseline to 12 months ]

7.  Secondary:   Quality of Life (Short Form Health Survey; SF-36); Cortisol (Basal a.m. and Diurnal Change); T-cell Activation (i.e. CD38-cell Surface Marker) and NK Cell Number and Function; Autonomic Nervous System Activity ; Cell Aging   [ Time Frame: 3, 6, and 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Patricia Moran, PhD
Organization: UCSF Osher Center for Integrative Medicine
phone: 415.353.9745

Responsible Party: University of California, San Francisco Identifier: NCT00271856     History of Changes
Other Study ID Numbers: P01AT002024 ( U.S. NIH Grant/Contract )
First Submitted: December 30, 2005
First Posted: January 4, 2006
Results First Submitted: August 3, 2011
Results First Posted: March 6, 2012
Last Update Posted: April 17, 2012