Trial Outcomes & Findings for Mindfulness Meditation as a Rehabilitation Strategy for Persons With Schizophrenia (NCT NCT00936351)
NCT ID: NCT00936351
Last Updated: 2015-04-10
Results Overview
total hours worked over the duration of the 24-week treatment
COMPLETED
NA
34 participants
week 1 through week 24 of treatment
2015-04-10
Participant Flow
Participant milestones
| Measure |
Arm 1
Mindfulness Meditation
Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn.
|
Arm 2
Support Group
The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mindfulness Meditation as a Rehabilitation Strategy for Persons With Schizophrenia
Baseline characteristics by cohort
| Measure |
Arm 1
n=18 Participants
Mindfulness Meditation
Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention has been adapted from mindfulness based stress reduction treatment.
|
Arm 2
n=16 Participants
Support Group
Support Group (control): A support group during which participants can discuss with each other any issues, problems, or successes at work will be conducted as the control portion.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
53.2 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
50.1 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
51.7 years
STANDARD_DEVIATION 8.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 1 through week 24 of treatmentPopulation: 3 participants were not included due to early dropout
total hours worked over the duration of the 24-week treatment
Outcome measures
| Measure |
Arm 1
n=16 Participants
Mindfulness Meditation
Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn.
|
Arm 2
n=15 Participants
Support Group
The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving.
|
|---|---|---|
|
Hours
|
293.5 total hours worked during treatment
Standard Deviation 40.2
|
234.5 total hours worked during treatment
Standard Deviation 96.1
|
PRIMARY outcome
Timeframe: week 24The Work Behavior Inventory (WBI: Bryson, et al., 1997) assesses work performance for persons with severe mental illness based on a trained rater's observation of participants at work and an interview with their supervisor. Each of the 35 WBI items are rated as 1- 5 ("persistent problem area" to "frequent area of strength"). The total score is the sum of five sub-scales (social skills, cooperativeness, work habits, work quality, and personal presentation). We divided the total score by 35 to produce a mean score that is conducive to interpretation since there are no established cut-offs for interpretation of the total score. Thus the mean scores range from 1-5 and are interpretable based on the anchors for the likert scale ranging from 1 (persistent problem area" to 5 ("frequent area of strength). Good to excellent interrater reliability was found for raters in this study, with intraclass correlations of .79-.98.
Outcome measures
| Measure |
Arm 1
n=16 Participants
Mindfulness Meditation
Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn.
|
Arm 2
n=15 Participants
Support Group
The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving.
|
|---|---|---|
|
Work Behavior Inventory
|
3.6 units on a scale
Standard Deviation 0.4
|
3.0 units on a scale
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: weeks 1-24Vocational rehabilitation staff tracked weekly work hours verified by supervisors and reported the data to study staff during the 24-week interventions. Therefore possible values for total weeks worked range from 1-24.
Outcome measures
| Measure |
Arm 1
n=16 Participants
Mindfulness Meditation
Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn.
|
Arm 2
n=15 Participants
Support Group
The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving.
|
|---|---|---|
|
Weeks
|
15.2 total number of weeks
Standard Deviation 1.9
|
12.8 total number of weeks
Standard Deviation 4.7
|
Adverse Events
Arm 1
Arm 2
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