N/A
N=110
Mindfulness-Based Stress Reduction to Improve Neuropsychological Functioning in Acquired Brain Injury
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT03969563 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: State-Trait Anxiety Inventory — 32.8; 32.5 Score on a scale — p=.694
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness-based Stress Reduction (Behavioral); Brain Health Education (Behavioral)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY State-Trait Anxiety Inventory |
32.8; 32.5 | .694 |
| SECONDARY Geriatric Depression Scale - 30 |
6.5; 7.9 | .837 |
Summary
Thousands of Veterans suffer a stroke every year, and these individuals often suffer emotional and cognitive changes that negatively affect their quality of life as well as their ability to recover. In addition to traditional rehabilitation such as physical and occupational therapy, a number of alternative treatments are now being studied for their ability to enhance patients' recovery following stroke. One of these treatments, Mindfulness-Based Stress Reduction or MBSR, involves an 8-week course that teaches individuals strategies such as breathing techniques, meditation, and movement therapy. The current study proposes to teach MBSR to a group of Veterans with a history of stroke to determine whether this type of intervention has beneficial effects on psychological and cognitive functioning. The investigators hope to find that MBSR is a useful, additional intervention that can improve Veterans' well-being and quality of life as they recover from stroke.
Eligibility Criteria
Inclusion Criteria
- history of a single, chronic right or left hemisphere stroke
- defined here as > 3 months post-onset so that residual symptoms have stabilized)
- native English proficiency
- at least mild level of depression
- 14 on Beck Depression Inventory-II94,95
- and/or mild anxiety
- 8 on the Beck Anxiety Inventory27
- language within normal limits
- Western Aphasia Battery score > 93.7104
- scores already available in the investigators' stroke patient database so that language deficits will not interfere with the intervention
Exclusion Criteria
- a pre-morbid neurologic history or history of schizophrenia spectrum and other psychotic disorders
- including depressive disorders with psychotic features
- bipolar disorders (to avoid potential confounds in neuropsychological testing)
- Mini-Mental State Examination score <19 (suggesting moderate to severe cognitive impairment that is a contraindication in effectively participating in the MBSR intervention52)
- recent substance abuse/dependence disorder (< 1 year)
- acutely suicidal
- concurrent involvement in another rehabilitation program
- significant visual or hearing disabilities that would preclude participating in the program
Data sourced from ClinicalTrials.gov (NCT03969563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.