Trial Outcomes & Findings for Staying Well: A Clinical Trial of Mindfulness-Based Stress Reduction and Education Groups for HIV (NCT NCT00271856)
NCT ID: NCT00271856
Last Updated: 2012-04-17
Results Overview
COMPLETED
PHASE2
177 participants
baseline to 12 months
2012-04-17
Participant Flow
Participants were recruited between July 2005 to August 2008 through newspaper advertisements, electronic bulletin boards, community postings and fliers in clinics.
Enrolled participants were screened to determine if inclusion criteria were met. This process included structured phone interviews, medical history review, and laboratory results.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
88
|
|
Overall Study
COMPLETED
|
78
|
70
|
|
Overall Study
NOT COMPLETED
|
11
|
18
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
7
|
|
Overall Study
Lost to Follow-up
|
10
|
11
|
Baseline Characteristics
Staying Well: A Clinical Trial of Mindfulness-Based Stress Reduction and Education Groups for HIV
Baseline characteristics by cohort
| Measure |
0 Mindfulness-Based Stress Reduction (MBSR)
n=89 Participants
Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
|
1-HIV Education/Self-management
n=88 Participants
HIV education/self-management workshop: 8 weekly classes.
|
Total
n=177 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
89 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age Continuous
|
41.1 years
STANDARD_DEVIATION 9.36 • n=5 Participants
|
40.5 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
40.8 years
STANDARD_DEVIATION 9.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
89 participants
n=5 Participants
|
88 participants
n=7 Participants
|
177 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 12 monthsPopulation: Intent to treat (ITT) analyses. Multiple imputation method used for those who started antiretroviral therapy (ART) between 0 and 12 months.
Outcome measures
| Measure |
0 Mindfulness-Based Stress Reduction (MBSR)
n=76 Participants
Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
|
1-HIV Education/Self-management
n=68 Participants
HIV education/self-management workshop: 8 weekly classes.
|
|---|---|---|
|
Change in CD4 T-cell Count
|
-57.1 cells/µl
Interval -91.2 to -23.0
|
-70.3 cells/µl
Interval -105.5 to -35.1
|
PRIMARY outcome
Timeframe: baseline to 12 monthsPopulation: ITT analyses.
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.
Outcome measures
| Measure |
0 Mindfulness-Based Stress Reduction (MBSR)
n=76 Participants
Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
|
1-HIV Education/Self-management
n=68 Participants
HIV education/self-management workshop: 8 weekly classes.
|
|---|---|---|
|
Change in Depression as Measured by Beck Depression Inventory (BDI)
|
-1.85 scores on the scale
Interval -3.66 to -0.035
|
-1.68 scores on the scale
Interval -3.48 to 0.13
|
PRIMARY outcome
Timeframe: baseline to 12 monthsPopulation: ITT analyses.
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.
Outcome measures
| Measure |
0 Mindfulness-Based Stress Reduction (MBSR)
n=76 Participants
Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
|
1-HIV Education/Self-management
n=68 Participants
HIV education/self-management workshop: 8 weekly classes.
|
|---|---|---|
|
Change in Perceived Stress as Measured by Perceived Stress Scale (PSS)
|
-0.58 scores on the scale
Interval -2.14 to 0.99
|
-2.03 scores on the scale
Interval -3.35 to -0.71
|
PRIMARY outcome
Timeframe: baseline to 12 monthsPopulation: ITT analyses
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.
Outcome measures
| Measure |
0 Mindfulness-Based Stress Reduction (MBSR)
n=76 Participants
Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
|
1-HIV Education/Self-management
n=68 Participants
HIV education/self-management workshop: 8 weekly classes.
|
|---|---|---|
|
Change in Positive and Negative Affect (PANAS) Positive Affect (PA) Score
|
1.20 scores on the scale
Interval -0.74 to 3.13
|
1.64 scores on the scale
Interval -0.22 to 3.5
|
PRIMARY outcome
Timeframe: baseline to 12 monthsPopulation: ITT analyses.
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.
Outcome measures
| Measure |
0 Mindfulness-Based Stress Reduction (MBSR)
n=76 Participants
Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
|
1-HIV Education/Self-management
n=68 Participants
HIV education/self-management workshop: 8 weekly classes.
|
|---|---|---|
|
Change in Positive and Negative Affect Scale (PANAS) Negative Affect (NA) Score
|
-2.17 scores on the scale
Interval -4.25 to -0.085
|
-2.63 scores on the scale
Interval -4.27 to -0.99
|
PRIMARY outcome
Timeframe: baseline to 12 monthsPopulation: ITT analyses.
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.
Outcome measures
| Measure |
0 Mindfulness-Based Stress Reduction (MBSR)
n=76 Participants
Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
|
1-HIV Education/Self-management
n=68 Participants
HIV education/self-management workshop: 8 weekly classes.
|
|---|---|---|
|
Change in Depression as Measured by the Patient Health Questionnaire-9 (PHQ-9)
|
-1.00 scores on the scale
Interval -2.44 to 0.44
|
-1.46 scores on the scale
Interval -2.71 to -0.2
|
SECONDARY outcome
Timeframe: 3, 6, and 12 monthsOutcome measures
Outcome data not reported
Adverse Events
0 Mindfulness-Based Stress Reduction (MBSR)
1-HIV Education/Self-management
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Patricia Moran, PhD
UCSF Osher Center for Integrative Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place