Trial Outcomes & Findings for Mindfulness Based Stress Reduction and Post-Stroke Cognition (NCT NCT04302493)
NCT ID: NCT04302493
Last Updated: 2024-12-20
Results Overview
The Montreal Cognitive Assessment (MoCA) tests executive function, attention, concentration, memory, and processing speed. The MoCA is scored on a scale of 0-30. Scores of less than 26 are considered abnormal.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Pre-intervention (1 month post-stroke) and post-intervention visit (6 months post-stroke)
Results posted on
2024-12-20
Participant Flow
Participant milestones
| Measure |
Mindfulness Based Stress Reduction (MBSR)
Participants randomized to the MBSR arm will undergo a standard 8 week course.
Mindfulness Based Stress Reduction (MBSR): Participants randomized to the MBSR arm will undergo a standard 8 week course of MBSR taught by a psychologist trained in the MBSR protocol and encouraged to engage in additional individual mindfulness sessions using a cell phone application.
|
Stroke Support Group (SSG)
As a control group, participants will participate in 8 weeks of weekly Stroke Support Group.
Stroke Support Group (SSG): As a control group, participants randomized to the SSG arm will participate in 8 weeks of weekly Stroke Support Group sessions to experience activity and socialization without additional mindfulness training.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mindfulness Based Stress Reduction and Post-Stroke Cognition
Baseline characteristics by cohort
| Measure |
Mindfulness Based Stress Reduction (MBSR)
n=16 Participants
Participants randomized to the MBSR arm will undergo a standard 8 week course.
Mindfulness Based Stress Reduction (MBSR): Participants randomized to the MBSR arm will undergo a standard 8 week course of MBSR taught by a psychologist trained in the MBSR protocol and encouraged to engage in additional individual mindfulness sessions using a cell phone application.
|
Stroke Support Group (SSG)
n=14 Participants
As a control group, participants will participate in 8 weeks of weekly Stroke Support Group.
Stroke Support Group (SSG): As a control group, participants randomized to the SSG arm will participate in 8 weeks of weekly Stroke Support Group sessions to experience activity and socialization without additional mindfulness training.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
63.6 years
STANDARD_DEVIATION 17.2 • n=7 Participants
|
64.7 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 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
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 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
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Education
|
12.8 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
14.6 years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
13.5 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-intervention (1 month post-stroke) and post-intervention visit (6 months post-stroke)The Montreal Cognitive Assessment (MoCA) tests executive function, attention, concentration, memory, and processing speed. The MoCA is scored on a scale of 0-30. Scores of less than 26 are considered abnormal.
Outcome measures
| Measure |
Mindfulness Based Stress Reduction (MBSR)
n=14 Participants
Participants randomized to the MBSR arm will undergo a standard 8 week course.
Mindfulness Based Stress Reduction (MBSR): Participants randomized to the MBSR arm will undergo a standard 8 week course of MBSR taught by a psychologist trained in the MBSR protocol and encouraged to engage in additional individual mindfulness sessions using a cell phone application.
|
Stroke Support Group (SSG)
n=14 Participants
As a control group, participants will participate in 8 weeks of weekly Stroke Support Group.
Stroke Support Group (SSG): As a control group, participants randomized to the SSG arm will participate in 8 weeks of weekly Stroke Support Group sessions to experience activity and socialization without additional mindfulness training.
|
|---|---|---|
|
Change in Cognition as Assessed by the Montreal Cognitive Assessment Score
1 month
|
23.5 score on a scale
Standard Deviation 5.2
|
22.5 score on a scale
Standard Deviation 5.9
|
|
Change in Cognition as Assessed by the Montreal Cognitive Assessment Score
6 months
|
25.5 score on a scale
Standard Deviation 3.7
|
23.7 score on a scale
Standard Deviation 6.0
|
PRIMARY outcome
Timeframe: Pre-intervention (1 month post-stroke) and post-intervention visit (6 months post-stroke)Population: 21 patients returned and successfully completed their follow-up MEG leaving 21 pairs of MEG data for analysis of this outcome.
Participants will undergo an MEG evaluating functional connectivity during resting state. GC links within the ipsilesional FPC were determined and differences in link count is reported below.
Outcome measures
| Measure |
Mindfulness Based Stress Reduction (MBSR)
n=13 Participants
Participants randomized to the MBSR arm will undergo a standard 8 week course.
Mindfulness Based Stress Reduction (MBSR): Participants randomized to the MBSR arm will undergo a standard 8 week course of MBSR taught by a psychologist trained in the MBSR protocol and encouraged to engage in additional individual mindfulness sessions using a cell phone application.
|
Stroke Support Group (SSG)
n=8 Participants
As a control group, participants will participate in 8 weeks of weekly Stroke Support Group.
Stroke Support Group (SSG): As a control group, participants randomized to the SSG arm will participate in 8 weeks of weekly Stroke Support Group sessions to experience activity and socialization without additional mindfulness training.
|
|---|---|---|
|
Change in Cerebral Activity as Assessed by Functional Connectivity on Magnetoencephalography (MEG)
1 month
|
1.99 GC links
Standard Error 0.83
|
0 GC links
Standard Error 0
|
|
Change in Cerebral Activity as Assessed by Functional Connectivity on Magnetoencephalography (MEG)
6 months
|
2.19 GC links
Standard Error 0.90
|
0 GC links
Standard Error 0
|
PRIMARY outcome
Timeframe: Pre-intervention (1 month post-stroke) and post-intervention visit (6 months post-stroke)Patient-reported assessment of quality of life (Likert scale 1-7 with 7 being a better QOL) at the 1 and 6 month visits. Mean of participant choice is reported.
Outcome measures
| Measure |
Mindfulness Based Stress Reduction (MBSR)
n=14 Participants
Participants randomized to the MBSR arm will undergo a standard 8 week course.
Mindfulness Based Stress Reduction (MBSR): Participants randomized to the MBSR arm will undergo a standard 8 week course of MBSR taught by a psychologist trained in the MBSR protocol and encouraged to engage in additional individual mindfulness sessions using a cell phone application.
|
Stroke Support Group (SSG)
n=14 Participants
As a control group, participants will participate in 8 weeks of weekly Stroke Support Group.
Stroke Support Group (SSG): As a control group, participants randomized to the SSG arm will participate in 8 weeks of weekly Stroke Support Group sessions to experience activity and socialization without additional mindfulness training.
|
|---|---|---|
|
Change in Quality of Life as Assessed by a Likert Scale
1 month
|
5.7 score on a scale
Standard Deviation 2.2
|
6.1 score on a scale
Standard Deviation 1.1
|
|
Change in Quality of Life as Assessed by a Likert Scale
6 months
|
5.2 score on a scale
Standard Deviation 1.9
|
5.1 score on a scale
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: Pre-intervention (1 months post-stroke) and post-intervention visit (6 months post-stroke)The PHQ-9 will be administered to participants to evaluate for post-stroke depression. The PHQ-9 is scored on a scale of 0-27 with scores of 5-9 being indicative of mild depression and higher scores more severe depression.
Outcome measures
| Measure |
Mindfulness Based Stress Reduction (MBSR)
n=14 Participants
Participants randomized to the MBSR arm will undergo a standard 8 week course.
Mindfulness Based Stress Reduction (MBSR): Participants randomized to the MBSR arm will undergo a standard 8 week course of MBSR taught by a psychologist trained in the MBSR protocol and encouraged to engage in additional individual mindfulness sessions using a cell phone application.
|
Stroke Support Group (SSG)
n=14 Participants
As a control group, participants will participate in 8 weeks of weekly Stroke Support Group.
Stroke Support Group (SSG): As a control group, participants randomized to the SSG arm will participate in 8 weeks of weekly Stroke Support Group sessions to experience activity and socialization without additional mindfulness training.
|
|---|---|---|
|
Change in Depression as Assessed by the Patient Health Questionnaire (PHQ-9)
1 month
|
6.7 score on a scale
Standard Deviation 7.3
|
5.2 score on a scale
Standard Deviation 5.9
|
|
Change in Depression as Assessed by the Patient Health Questionnaire (PHQ-9)
6 months
|
6.1 score on a scale
Standard Deviation 6.9
|
4.9 score on a scale
Standard Deviation 3.9
|
Adverse Events
Mindfulness Based Stress Reduction (MBSR)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Stroke Support Group (SSG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Elisabeth B. Marsh, MD
Johns Hopkins School of Medicine
Phone: 410-550-8703
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place