- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03969563
Mindfulness-Based Stress Reduction to Improve Neuropsychological Functioning in Acquired Brain Injury
January 23, 2024 updated by: VA Office of Research and Development
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Stroke affects approximately 800,000 Americans every year, including thousands of Veterans, and is a leading cause of disability in the US.
While many stroke patients receive rehabilitation during the acute and post-acute phases of stroke, many individuals suffer chronic deficits and have few options for continued treatment.
A number of low-cost, alternative treatments are now being tested for their usefulness in treating neuropsychological deficits in chronic stroke patients.
One of the best studied of these treatments is Mindfulness-Based Stress Reduction (MBSR), which involves an 8-week course led by a trained instructor.
MBSR teaches individuals strategies for coping with their injury, such as meditation, breathing techniques, and yoga.
A handful of preliminary studies have shown that MBSR is effective in reducing symptoms of anxiety and depression in stroke patients, as well as enhancing performance on cognitive tasks.
However, only a single randomized controlled trial of MBSR in stroke has been published to date, and that study suffered from a number of weaknesses such as the lack of an active control group.
Moreover, no previous study has assessed the usefulness of MBSR for stroke in a Veteran population.
Therefore, the current study proposes to undertake a rigorous, randomized controlled trial of MBSR in Veterans with a history of stroke, using an active control group, blinded examiners, and a 6-month follow-up session to determine whether the benefits of MBSR are long-lasting.
For the study, 120 Veterans with a history of chronic stroke will be recruited: 60 participants will be randomly assigned to the MBSR intervention, and 60 participants will be assigned to a Brain Health class that is matched to the MBSR intervention with respect to the instructor, number of hours of instruction, homework activities, and class size.
A blinded examiner will complete a neuropsychological assessment of patients' emotional and cognitive status at three time points: 1) prior to the intervention, 2) following the intervention, and 3) six months later.
Evaluation of the MBSR intervention will test for improvements in anxiety and depressive symptomatology following the intervention, relative to the Brain Health group, as well as improvements on a cognitive test battery.
It is predicted that improvements associated with the MBSR intervention will still be present at the 6-month follow-up assessment as well.
The final objective of the current proposal is to determine whether the site of a patient's stroke plays a role in their ability to benefit from MBSR.
Previous research has suggested that left prefrontal cortex plays a critical role underlying the effects of MBSR.
Thus, it is predicted that involvement of this brain region will modulate the observed effects.
Such information could be used to target those Veterans who can most benefit from the proposed intervention.
If shown to be effective, MBSR could provide a low-cost, non-invasive rehabilitative treatment for Veterans with acquired brain injury that can improve their neuropsychological functioning and general sense of well-being.
Study Type
Interventional
Enrollment (Actual)
109
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dawn C Schwenke, PhD MS
- Phone Number: 5447 (520) 792-1450
- Email: Dawn.Schwenke@va.gov
Study Locations
-
-
California
-
Sacramento, California, United States, 95655-4200
- VA Northern California Health Care System, Mather, CA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MBSR
8-week Mindfulness-based Stress Reduction class that trains participants in mindfulness, meditation, and yoga.
|
8-week Mindfulness-based Stress Reduction class that trains participants in mindfulness, meditation, and yoga.
Other Names:
|
Active Comparator: Brain Health Education
8-week Brain Health education class that teaches participants about brain-behavior relationships, nutrition, aging facts, sleep, and memory.
|
8-week Brain Health education class that teaches participants about brain-behavior relationships, nutrition, aging facts, sleep, and memory.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 weeks
|
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.
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 weeks
|
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.
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Juliana V. Baldo, PhD, VA Northern California Health Care System, Mather, CA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 6, 2020
Primary Completion (Actual)
January 5, 2024
Study Completion (Actual)
January 15, 2024
Study Registration Dates
First Submitted
May 29, 2019
First Submitted That Met QC Criteria
May 29, 2019
First Posted (Actual)
May 31, 2019
Study Record Updates
Last Update Posted (Estimated)
January 24, 2024
Last Update Submitted That Met QC Criteria
January 23, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D2951-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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