Trial Outcomes & Findings for Comparison of Two Behavioral Treatments for Stress Reduction (NCT NCT00625807)
NCT ID: NCT00625807
Last Updated: 2018-08-07
Results Overview
Seed based functional connectivity analysis was performed using the Connectivity Toolbox (CONN) implemented within the Statistical Parametric Mapping program (SPM8; Welcome Department of Cognitive Neurology). Our seeds were located in the right inferior frontal gyrus pars opercularis (MNI coordinates: 54, 14, 16) and the dorsal anterior insula (MNI coordinates: 32, 20, 0). Note - MRI data from some subjects was either missing, not collected, or corrupted, and so the analyses were performed on just the subject of subjects who had complete datasets. This assessment reflects the total number of voxels per group.
COMPLETED
NA
50 participants
Week 8
2018-08-07
Participant Flow
Participant milestones
| Measure |
Relaxation Response (RR)
One of the 2 stress reduction courses
A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing relaxation
|
Mindfulness Based Stress Reduction (MBSR)
One of the 2 stress reduction courses
A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing mindfulness
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
28
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
8
|
Reasons for withdrawal
| Measure |
Relaxation Response (RR)
One of the 2 stress reduction courses
A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing relaxation
|
Mindfulness Based Stress Reduction (MBSR)
One of the 2 stress reduction courses
A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing mindfulness
|
|---|---|---|
|
Overall Study
schedule conflict
|
2
|
8
|
Baseline Characteristics
Comparison of Two Behavioral Treatments for Stress Reduction
Baseline characteristics by cohort
| Measure |
Relaxation Response
n=22 Participants
One of the 2 stress reduction courses
Relaxation Response: A well-validated 8 week stress reduction course. Participants will be asked to perform stress reduction techniques from the Relaxation Response Program each night for 20 minutes throughout the entire 8-week course
|
MBSR
n=28 Participants
One of the 2 stress reduction courses
MBSR: A well-validated 8 week stress reduction course. Classes meet once a week from 5-8:30 PM. Participants will be asked to perform stress reduction techniques from the MBSR program each night for 20 minutes throughout the entire 8-week course
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
37 years
STANDARD_DEVIATION 4.7 • n=7 Participants
|
37.9 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Seed based functional connectivity analysis was performed using the Connectivity Toolbox (CONN) implemented within the Statistical Parametric Mapping program (SPM8; Welcome Department of Cognitive Neurology). Our seeds were located in the right inferior frontal gyrus pars opercularis (MNI coordinates: 54, 14, 16) and the dorsal anterior insula (MNI coordinates: 32, 20, 0). Note - MRI data from some subjects was either missing, not collected, or corrupted, and so the analyses were performed on just the subject of subjects who had complete datasets. This assessment reflects the total number of voxels per group.
Outcome measures
| Measure |
Relaxation Response (RR)
n=16 Participants
One of the 2 stress reduction courses
A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing relaxation
|
Mindfulness Based Stress Reduction (MBSR)
n=18 Participants
One of the 2 stress reduction courses
A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing mindfulness
|
|---|---|---|
|
Brain Activity (fMRI) During the Body Scan Meditation
|
74 voxels
|
82 voxels
|
PRIMARY outcome
Timeframe: Pre, 8 weeksPopulation: Individuals who completed at least one measure at post
The Five Facet Mindfulness Questionnaire (FFMQ) has been developed as a reliable and valid comprehensive instrument for assessing different aspects of mindfulness in community samples. Scores range from 39-195 with higher scores meaning more mindfulness.
Outcome measures
| Measure |
Relaxation Response (RR)
n=20 Participants
One of the 2 stress reduction courses
A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing relaxation
|
Mindfulness Based Stress Reduction (MBSR)
n=20 Participants
One of the 2 stress reduction courses
A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing mindfulness
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire
Pre
|
130.8 units on a scale
Standard Deviation 17.7
|
125.3 units on a scale
Standard Deviation 17.7
|
|
Five Facet Mindfulness Questionnaire
week 8
|
144.2 units on a scale
Standard Deviation 20.6
|
139.1 units on a scale
Standard Deviation 21.1
|
PRIMARY outcome
Timeframe: Pre, 8 weeksPopulation: Individuals who completed at least one measure at post
The PSS is brief, validated and widely used psychological instrument for assessing a subject's perception of stress change. Scores range from 0-40 with higher scores meaning more stress
Outcome measures
| Measure |
Relaxation Response (RR)
n=20 Participants
One of the 2 stress reduction courses
A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing relaxation
|
Mindfulness Based Stress Reduction (MBSR)
n=20 Participants
One of the 2 stress reduction courses
A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing mindfulness
|
|---|---|---|
|
Perceived Stress Scale
Pre
|
14.1 units on a scale
Standard Deviation 6.6
|
18.4 units on a scale
Standard Deviation 6.7
|
|
Perceived Stress Scale
week 8
|
11.3 units on a scale
Standard Deviation 5.5
|
12.3 units on a scale
Standard Deviation 5.3
|
PRIMARY outcome
Timeframe: Pre, 8 weeksPopulation: Individuals who completed at least one measure at post
The Penn State Worry Questionnaire (PSWQ) is a standard self-report questionnaire that is designed to assess symptoms of General Anxiety Disorder. scores range from 16-80 with higher scores meaning more stress.
Outcome measures
| Measure |
Relaxation Response (RR)
n=19 Participants
One of the 2 stress reduction courses
A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing relaxation
|
Mindfulness Based Stress Reduction (MBSR)
n=18 Participants
One of the 2 stress reduction courses
A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing mindfulness
|
|---|---|---|
|
Penn State Worry Questionnaire
Pre
|
42.6 units on a scale
Standard Deviation 11.9
|
50.5 units on a scale
Standard Deviation 13.1
|
|
Penn State Worry Questionnaire
week 8
|
37.7 units on a scale
Standard Deviation 10.1
|
44.3 units on a scale
Standard Deviation 12.0
|
PRIMARY outcome
Timeframe: Pre, 8 weeksPopulation: Individuals who completed at least one measure at post
the Anxiety Sensitivity Index (ASI) is a measure of individuals discomfort with a variety of sensations associated with anxiety and panic and tends to be substantially higher in those with panic disorder (and attacks) than in those with General Anxiety Disorder. Scores range from 0 - 64. Lower scores mean lower anxiety.
Outcome measures
| Measure |
Relaxation Response (RR)
n=18 Participants
One of the 2 stress reduction courses
A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing relaxation
|
Mindfulness Based Stress Reduction (MBSR)
n=19 Participants
One of the 2 stress reduction courses
A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing mindfulness
|
|---|---|---|
|
Anxiety Severity Index
Pre
|
29.8 units on a scale
Standard Deviation 7.3
|
31.9 units on a scale
Standard Deviation 9.4
|
|
Anxiety Severity Index
week 8
|
25.4 units on a scale
Standard Deviation 5.7
|
30.9 units on a scale
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: Pre, week 8Population: individuals who completed the measure at week 8
This scale assesses one's ability to be forgiving and kind to oneself in difficult circumstances. Scores range from 1-5. Higher scores mean more self compassion.
Outcome measures
| Measure |
Relaxation Response (RR)
n=20 Participants
One of the 2 stress reduction courses
A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing relaxation
|
Mindfulness Based Stress Reduction (MBSR)
n=20 Participants
One of the 2 stress reduction courses
A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing mindfulness
|
|---|---|---|
|
Self Compassion
pre
|
2.9 units on a scale
Standard Deviation .67
|
3.1 units on a scale
Standard Deviation .6
|
|
Self Compassion
week 8
|
3.2 units on a scale
Standard Deviation .72
|
3.6 units on a scale
Standard Deviation .7
|
Adverse Events
Relaxation Response
MBSR
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place