Mindfulness-Based Stress Reduction to Improve Neuropsychological Functioning in Acquired Brain Injury
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ClinicalTrials.gov Identifier: NCT03969563 |
Recruitment Status :
Recruiting
First Posted : May 31, 2019
Last Update Posted : November 19, 2020
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Condition or disease | Intervention/treatment | Phase |
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Stroke | Behavioral: Mindfulness-based Stress Reduction Behavioral: Brain Health Education | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Participants are assigned to either the MBSR or Brain Health education class, in parallel for the duration of the study. |
Masking: | Single (Outcomes Assessor) |
Masking Description: | The neuropsychologist doing the assessments pre- and post-intervention will not be aware of the participant's group assignment. |
Primary Purpose: | Treatment |
Official Title: | Mindfulness-Based Stress Reduction to Improve Neuropsychological Functioning in Acquired Brain Injury |
Actual Study Start Date : | January 6, 2020 |
Estimated Primary Completion Date : | September 5, 2023 |
Estimated Study Completion Date : | December 22, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: MBSR
8-week Mindfulness-based Stress Reduction class that trains participants in mindfulness, meditation, and yoga.
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Behavioral: Mindfulness-based Stress Reduction
8-week Mindfulness-based Stress Reduction class that trains participants in mindfulness, meditation, and yoga.
Other Name: MBSR |
Active Comparator: Brain Health Education
8-week Brain Health education class that teaches participants about brain-behavior relationships, nutrition, aging facts, sleep, and memory.
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Behavioral: Brain Health Education
8-week Brain Health education class that teaches participants about brain-behavior relationships, nutrition, aging facts, sleep, and memory. |
- Beck Anxiety Inventory [ Time Frame: 10 weeks ]The primary psychological outcome measure is the Beck Anxiety Inventory to measure changes in subjective symptoms of anxiety from pre- to post-intervention. The range is 0 to 63, with 0 being no/minimal anxiety and 63 being severe anxiety. A lower score post-intervention indicates improvement on this measure.
- Working Memory Score on the Repeatable Battery for the Assessment of Neuropsychological Status [ Time Frame: 10 weeks ]The primary cognitive outcome measure is the Repeatable Battery for the Assessment of Neuropsychological Status working memory score, which tests participants' ability to hold information in mind for several seconds. Raw scores will be converted to normative percentiles, which can range from 1-99th percentile. A higher percentile post-intervention indicates improvement on this measure.
- Beck Depression Inventory [ Time Frame: 10 weeks ]The secondary psychological outcome measure is a change in depression scores from pre- to post-intervention. The range is 0 to 63, with 0 being no/minimal depression and 63 being severe depression. A lower score post-intervention indicates improvement on this measure.
- Attention Score on the Repeatable Battery for the Assessment of Neuropsychological Status [ Time Frame: 10 weeks ]The secondary cognitive outcome score is the Repeatable Battery for the Assessment of Neuropsychological Status attention score, which tests participants' ability to stay focused on a stimulus and respond with minimal distraction. Raw scores will be converted to normative percentiles, which can range from 1-99th percentile. A higher percentile post-intervention indicates improvement on this measure.

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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
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at least mild level of depression
- 14 on Beck Depression Inventory-II94,95
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and/or mild anxiety
- 8 on the Beck Anxiety Inventory27
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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:
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03969563
Contact: Dawn C Schwenke, PhD MS | (916) 843-2776 | Dawn.Schwenke@va.gov | |
Contact: Miguel A Sanchez | (925) 372-2292 | Miguel.Sanchez@va.gov |
United States, California | |
VA Northern California Health Care System, Mather, CA | Recruiting |
Sacramento, California, United States, 95655 | |
Contact: Jefferson Lee 916-843-2769 Jefferson.Lee2@va.gov | |
Contact: Jary Larsen (916) 366-5333 | |
Principal Investigator: Juliana V. Baldo, PhD |
Principal Investigator: | Juliana V. Baldo, PhD | VA Northern California Health Care System, Mather, CA |
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT03969563 |
Other Study ID Numbers: |
D2951-R |
First Posted: | May 31, 2019 Key Record Dates |
Last Update Posted: | November 19, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
stroke MBSR meditation mindfulness yoga |
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |