Trial Outcomes & Findings for Mindfulness-Based Stress Reduction to Improve Neuropsychological Functioning in Acquired Brain Injury (NCT NCT03969563)
NCT ID: NCT03969563
Last Updated: 2025-02-04
Results Overview
The primary psychological outcome measure is the State-Trait Anxiety Inventory to measure changes in subjective symptoms of anxiety from pre- to post-intervention. The range is 20-80, with 20-37 being no/minimal anxiety and 45-80 being severe anxiety. A lower score post-intervention indicates improvement on this measure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
10 weeks
Results posted on
2025-02-04
Participant Flow
Participant milestones
| Measure |
MBSR
8-week Mindfulness-based Stress Reduction class that trains participants in mindfulness, meditation, and yoga.
Mindfulness-based Stress Reduction: 8-week Mindfulness-based Stress Reduction class that trains participants in mindfulness, meditation, and yoga.
|
Brain Health Education
8-week Brain Health education class that teaches participants about brain-behavior relationships, nutrition, aging facts, sleep, and memory.
Brain Health Education: 8-week Brain Health education class that teaches participants about brain-behavior relationships, nutrition, aging facts, sleep, and memory.
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
53
|
|
Overall Study
COMPLETED
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
28
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mindfulness-Based Stress Reduction to Improve Neuropsychological Functioning in Acquired Brain Injury
Baseline characteristics by cohort
| Measure |
MBSR
n=57 Participants
8-week Mindfulness-based Stress Reduction class that trains participants in mindfulness, meditation, and yoga.
Mindfulness-based Stress Reduction: 8-week Mindfulness-based Stress Reduction class that trains participants in mindfulness, meditation, and yoga.
|
Brain Health Education
n=53 Participants
8-week Brain Health education class that teaches participants about brain-behavior relationships, nutrition, aging facts, sleep, and memory.
Brain Health Education: 8-week Brain Health education class that teaches participants about brain-behavior relationships, nutrition, aging facts, sleep, and memory.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
40 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Age, Continuous
|
67.7 years
STANDARD_DEVIATION 7.4 • n=99 Participants
|
67.8 years
STANDARD_DEVIATION 7.6 • n=107 Participants
|
67.7 years
STANDARD_DEVIATION 7.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian American
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
18 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latine
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
24 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Education
|
15 years
STANDARD_DEVIATION 2.2 • n=99 Participants
|
14.5 years
STANDARD_DEVIATION 2.8 • n=107 Participants
|
14.8 years
STANDARD_DEVIATION 2.5 • n=206 Participants
|
PRIMARY outcome
Timeframe: 10 weeksThe primary psychological outcome measure is the State-Trait Anxiety Inventory to measure changes in subjective symptoms of anxiety from pre- to post-intervention. The range is 20-80, with 20-37 being no/minimal anxiety and 45-80 being severe anxiety. A lower score post-intervention indicates improvement on this measure.
Outcome measures
| Measure |
MBSR
n=29 Participants
8-week Mindfulness-based Stress Reduction class that trains participants in mindfulness, meditation, and yoga.
Mindfulness-based Stress Reduction: 8-week Mindfulness-based Stress Reduction class that trains participants in mindfulness, meditation, and yoga.
|
Brain Health Education
n=30 Participants
8-week Brain Health education class that teaches participants about brain-behavior relationships, nutrition, aging facts, sleep, and memory.
Brain Health Education: 8-week Brain Health education class that teaches participants about brain-behavior relationships, nutrition, aging facts, sleep, and memory.
|
|---|---|---|
|
State-Trait Anxiety Inventory
|
32.8 Score on a scale
Standard Deviation 9
|
32.5 Score on a scale
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: 10 weeksThe secondary psychological outcome measure is a change in depression scores from pre- to post-intervention. The range is 0 to 30, with 0 being no/minimal depression and 20-30 being severe depression. A lower score post-intervention indicates improvement on this measure.
Outcome measures
| Measure |
MBSR
n=29 Participants
8-week Mindfulness-based Stress Reduction class that trains participants in mindfulness, meditation, and yoga.
Mindfulness-based Stress Reduction: 8-week Mindfulness-based Stress Reduction class that trains participants in mindfulness, meditation, and yoga.
|
Brain Health Education
n=30 Participants
8-week Brain Health education class that teaches participants about brain-behavior relationships, nutrition, aging facts, sleep, and memory.
Brain Health Education: 8-week Brain Health education class that teaches participants about brain-behavior relationships, nutrition, aging facts, sleep, and memory.
|
|---|---|---|
|
Geriatric Depression Scale - 30
|
6.5 Score on a scale
Standard Deviation 4.5
|
7.9 Score on a scale
Standard Deviation 6.9
|
Adverse Events
MBSR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Brain Health Education
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
Dr. Jerry Nadler, Chief of Research
VA Northern California Health Care System
Phone: 9168432776
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place