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

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ClinicalTrials.gov Identifier: NCT00271856
Recruitment Status : Completed
First Posted : January 4, 2006
Results First Posted : March 6, 2012
Last Update Posted : April 17, 2012
Sponsor:
Collaborator:
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
Enrollment 177

Recruitment Details Participants were recruited between July 2005 to August 2008 through newspaper advertisements, electronic bulletin boards, community postings and fliers in clinics.
Pre-assignment Details Enrolled participants were screened to determine if inclusion criteria were met. This process included structured phone interviews, medical history review, and laboratory results.
Arm/Group Title 0 Mindfulness-Based Stress Reduction (MBSR) 1-HIV Education/Self-management
Hide Arm/Group Description Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class. HIV education/self-management workshop: 8 weekly classes.
Period Title: Overall Study
Started 89 88
Completed 78 70
Not Completed 11 18
Reason Not Completed
Withdrawal by Subject             1             7
Lost to Follow-up             10             11
Arm/Group Title 0 Mindfulness-Based Stress Reduction (MBSR) 1-HIV Education/Self-management Total
Hide Arm/Group Description Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class. HIV education/self-management workshop: 8 weekly classes. Total of all reporting groups
Overall Number of Baseline Participants 89 88 177
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 88 participants 177 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
89
 100.0%
87
  98.9%
176
  99.4%
>=65 years
0
   0.0%
1
   1.1%
1
   0.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants 88 participants 177 participants
41.1  (9.36) 40.5  (9.5) 40.8  (9.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 88 participants 177 participants
Female
4
   4.5%
2
   2.3%
6
   3.4%
Male
85
  95.5%
86
  97.7%
171
  96.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 89 participants 88 participants 177 participants
89 88 177
1.Primary Outcome
Title Change in CD4 T-cell Count
Hide Description [Not Specified]
Time Frame baseline to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) analyses. Multiple imputation method used for those who started antiretroviral therapy (ART) between 0 and 12 months.
Arm/Group Title 0 Mindfulness-Based Stress Reduction (MBSR) 1-HIV Education/Self-management
Hide Arm/Group Description:
Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
HIV education/self-management workshop: 8 weekly classes.
Overall Number of Participants Analyzed 76 68
Mean (95% Confidence Interval)
Unit of Measure: cells/µl
-57.1
(-91.2 to -23.0)
-70.3
(-105.5 to -35.1)
2.Primary Outcome
Title Change in Depression as Measured by Beck Depression Inventory (BDI)
Hide Description The BDI is a widely used outcome measure for studies of depression. The BDI consists of 21 items that are rated on a 4-point scale according to how severely they are experienced. Scores range from 0-63, with higher scores reflecting greater depression.
Time Frame baseline to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analyses.
Arm/Group Title 0 Mindfulness-Based Stress Reduction (MBSR) 1-HIV Education/Self-management
Hide Arm/Group Description:
Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
HIV education/self-management workshop: 8 weekly classes.
Overall Number of Participants Analyzed 76 68
Mean (95% Confidence Interval)
Unit of Measure: scores on the scale
-1.85
(-3.66 to -0.035)
-1.68
(-3.48 to 0.13)
3.Primary Outcome
Title Change in Perceived Stress as Measured by Perceived Stress Scale (PSS)
Hide Description Perception of stress was measured with the 10-item version of the Perceived Stress Scale. This widely used measure of perceived stress was designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. Participants rate how often they felt or thought a certain way over the past month on a 4-point scale (0 = Never, 4 = Very Often). Scores range from 0-40, with higher scores reflecting greater perceived stress.
Time Frame baseline to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analyses.
Arm/Group Title 0 Mindfulness-Based Stress Reduction (MBSR) 1-HIV Education/Self-management
Hide Arm/Group Description:
Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
HIV education/self-management workshop: 8 weekly classes.
Overall Number of Participants Analyzed 76 68
Mean (95% Confidence Interval)
Unit of Measure: scores on the scale
-0.58
(-2.14 to 0.99)
-2.03
(-3.35 to -0.71)
4.Primary Outcome
Title Change in Positive and Negative Affect (PANAS) Positive Affect (PA) Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analyses
Arm/Group Title 0 Mindfulness-Based Stress Reduction (MBSR) 1-HIV Education/Self-management
Hide Arm/Group Description:
Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
HIV education/self-management workshop: 8 weekly classes.
Overall Number of Participants Analyzed 76 68
Mean (95% Confidence Interval)
Unit of Measure: scores on the scale
1.20
(-0.74 to 3.13)
1.64
(-0.22 to 3.50)
5.Primary Outcome
Title Change in Positive and Negative Affect Scale (PANAS) Negative Affect (NA) Score
Hide 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 Negative Affect (NA) score is derived from summing the scores on the 10 negative emotions. Scores on the NA subscale range from 0-40, with higher scores reflecting more negative affect over the past week.
Time Frame baseline to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analyses.
Arm/Group Title 0 Mindfulness-Based Stress Reduction (MBSR) 1-HIV Education/Self-management
Hide Arm/Group Description:
Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
HIV education/self-management workshop: 8 weekly classes.
Overall Number of Participants Analyzed 76 68
Mean (95% Confidence Interval)
Unit of Measure: scores on the scale
-2.17
(-4.25 to -0.085)
-2.63
(-4.27 to -0.99)
6.Primary Outcome
Title Change in Depression as Measured by the Patient Health Questionnaire-9 (PHQ-9)
Hide Description We used the Patient Health Questionnaire (PHQ-9) as a measure of depressive symptom severity. The PHQ-9 is the depression module of the self-administered version of the Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic instrument. Participants rate the frequency of 9 depression symptoms over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 27, with higher scores reflecting greater severity of depressive symptoms.
Time Frame baseline to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analyses.
Arm/Group Title 0 Mindfulness-Based Stress Reduction (MBSR) 1-HIV Education/Self-management
Hide Arm/Group Description:
Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
HIV education/self-management workshop: 8 weekly classes.
Overall Number of Participants Analyzed 76 68
Mean (95% Confidence Interval)
Unit of Measure: scores on the scale
-1.00
(-2.44 to 0.44)
-1.46
(-2.71 to -0.2)
7.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 3, 6, and 12 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 0 Mindfulness-Based Stress Reduction (MBSR) 1-HIV Education/Self-management
Hide Arm/Group Description Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class. HIV education/self-management workshop: 8 weekly classes.
All-Cause Mortality
0 Mindfulness-Based Stress Reduction (MBSR) 1-HIV Education/Self-management
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
0 Mindfulness-Based Stress Reduction (MBSR) 1-HIV Education/Self-management
Affected / at Risk (%) Affected / at Risk (%)
Total   0/89 (0.00%)   0/88 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
0 Mindfulness-Based Stress Reduction (MBSR) 1-HIV Education/Self-management
Affected / at Risk (%) Affected / at Risk (%)
Total   0/89 (0.00%)   0/88 (0.00%) 
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
ClinicalTrials.gov Identifier: NCT00271856     History of Changes
Other Study ID Numbers: P01AT002024 ( U.S. NIH Grant/Contract )
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