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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00271856
First received: December 30, 2005
Last updated: April 11, 2012
Last verified: April 2012
Results First Received: August 3, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV
Interventions: Behavioral: Mindfulness-Based Stress Reduction (MBSR)
Behavioral: HIV-education and self-management workshop

  Participant Flow
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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
  Description
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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    0 Mindfulness-Based Stress Reduction (MBSR)     1-HIV Education/Self-management     Total  
Number of Participants  
[units: participants]
  89     88     177  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     89     87     176  
>=65 years     0     1     1  
Age  
[units: years]
Mean ± Standard Deviation
  41.1  ± 9.36     40.5  ± 9.5     40.8  ± 9.41  
Gender  
[units: participants]
     
Female     4     2     6  
Male     85     86     171  
Region of Enrollment  
[units: participants]
     
United States     89     88     177  



  Outcome Measures
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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 ]
  Hide Outcome Measure 4

Measure Type Primary
Measure Title Change in Positive and Negative Affect (PANAS) Positive Affect (PA) Score
Measure Description Emotion was assessed with the Positive and Negative Affect Schedule (PANAS). The PANAS measures intensity of positive and negative emotions over the past week. The scale consists of 20 items--10 positive and 10 negative emotions. Respondents are asked to indicate how strongly they felt each emotion on a scale from 0 to 4 (not at all to extremely). The Positive Affect (PA) score is derived from summing the scores on the 10 positive emotions. Scores on the PA subscale range from 0-40, with higher scores reflecting more positive affect over the past week.
Time Frame baseline to 12 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT analyses

Reporting Groups
  Description
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.

Measured Values
    0 Mindfulness-Based Stress Reduction (MBSR)     1-HIV Education/Self-management  
Number of Participants Analyzed  
[units: participants]
  76     68  
Change in Positive and Negative Affect (PANAS) Positive Affect (PA) Score  
[units: scores on the scale]
Mean ( 95% Confidence Interval )
  1.20  
  ( -0.74 to 3.13 )  
  1.64  
  ( -0.22 to 3.50 )  

No statistical analysis provided for Change in Positive and Negative Affect (PANAS) Positive Affect (PA) Score



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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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
e-mail: moranp@ocim.ucsf.edu


No publications provided


Responsible Party: 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
Results First Received: August 3, 2011
Last Updated: April 11, 2012
Health Authority: United States: Federal Government