N/A
N=37
Wellness Programs for Brain-Injured Individuals
Depression · Anxiety · Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02600637 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Depression Score Change on Geriatric Depression Scale — -.29; -1.46 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MBSR (Behavioral); Brain Health class (Behavioral)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depression Score Change on Geriatric Depression Scale |
-.29; -1.46 | — |
| PRIMARY Anxiety Score Change on State-Trait Anxiety Inventory Questionnaire |
.57; -2.31 | — |
| SECONDARY Repeatable Battery for Assessment of Neuropsychological Status Battery Overall Cognitive Change Score |
7.69; 3.08 | — |
Summary
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 pilot study proposes to teach MBSR to a group of Veterans with a history of stroke to determine whether this type of intervention is feasible, acceptable to patients, and shows preliminary evidence of 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
- A history of a single, chronic right or left hemisphere stroke (> 6 months post-onset so that residual symptoms have stabilized)
- Age 20-80
- Native English proficiency
- At least mild level of depression and/or mild anxiety
- Language within normal limits 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
- Bipolar disorders
- Depressive disorders with psychotic features (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 (defined below)
- Concurrent involvement in another rehabilitation program
- Significant visual or hearing disabilities that would preclude participating in the program
- Medical history, including pre-morbid neurologic and psychiatric history, will be assessed with a standard medical questionnaire during the initial interview session as well as a review of patients' VA medical records
- Medications will not be an exclusionary factor for participation but will be recorded and tracked via VA computerized medical record systems
Data sourced from ClinicalTrials.gov (NCT02600637). 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.