StrokeNCT03969563
Mindfulness-Based Stress Reduction to Improve Neuropsychological Functioning in Acquired Brain Injury
A study testing Mindfulness-based Stress Reduction and Brain Health Education in people with Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Mindfulness-based Stress Reduction and Brain Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Northern California Health Care System, Mather, CA
Sacramento, California, 95655-4200
About this study
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.
Read the 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. Due to the COVID pandemic, we did not test patients on in-person RBANS cognitive testing as had been originally intended. We also used the Geriatric Depression Scale instead of the Beck Depression Inventory, and the State-Trait Anxiety Inventory instead of the Beck Anxiety Inventory, both of which are highly correlated with each other, due to test availability and cost/copyrights.
- Conditions
- Stroke
- Being tested
- Mindfulness-based Stress Reduction, Brain Health Education
- Keywords
- stroke, MBSR, meditation, mindfulness, yoga
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Stress ReductionBehavioural
Also called MBSR
8-week Mindfulness-based Stress Reduction class that trains participants in mindfulness, meditation, and yoga.
Brain Health EducationBehavioural
8-week Brain Health education class that teaches participants about brain-behavior relationships, nutrition, aging facts, sleep, and memory.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based Stress Reduction (MBSR) | Experimental | 8-week Mindfulness-based Stress Reduction class that trains participants in mindfulness, meditation, and yoga. Receives: Behavioral: Mindfulness-based Stress Reduction |
| Brain Health Education | Active comparator | 8-week Brain Health education class that teaches participants about brain-behavior relationships, nutrition, aging facts, sleep, and memory. Receives: Behavioral: Brain Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory
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.
Measured: 10 weeks
Secondary outcomes (1)
Geriatric Depression Scale - 30
The 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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start6 Jan 2020
- Primary completion5 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to either the MBSR or Brain Health education class, in parallel for the duration of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Juliana V. Baldo, PhD, Principal investigator, VA Northern California Health Care System, Mather, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969563
- Sponsor's protocol ID
- D2951-R
- Status last verified
- Jan 2025
- First submitted
- 29 May 2019
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lwi SJ, Paulraj SR, Schendel K, Dempsey DG, Curran BC, Herron TJ, Baldo JV. A Randomized, Controlled Pilot Study of Mindfulness-Based Stress Reduction in Healthy Older Adults. Clin Gerontol. 2023 May-Jun;46(3):330-345. doi: 10.1080/07317115.2022.2137075. Epub 2022 Nov 18.
PubMed 36398589Lwi SJ, Chok J, Schendel K, Herron TJ, Curran BC, Baldo JV. A randomized controlled trial of online mindfulness-based stress reduction in chronic stroke. Rehabil Psychol. 2026 Aug;71(3):404-416. doi: 10.1037/rep0000651. Epub 2026 Jan 5.
PubMed 41490301
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Stress Reduction to Improve Neuropsychological Functioning in Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT03969563
- Acronym / sponsor ID
- D2951-R
- Conditions
- Stroke
- Keywords
- stroke, MBSR, meditation, mindfulness, yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 31 May 2019 (actual)
- Results
- Posted 22 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. Due to the COVID pandemic, we did not test patients on in-person RBANS cognitive testing as had been originally intended. We also used the Geriatric Depression Scale instead of the Beck Depression Inventory, and the State-Trait Anxiety Inventory instead of the Beck Anxiety Inventory, both of which are highly correlated with each other, due to test availability and cost/copyrights.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to either the MBSR or Brain Health education class, in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Stress Reduction (MBSR) | Experimental | Behavioral: Mindfulness-based Stress Reduction8-week Mindfulness-based Stress Reduction class that trains participants in mindfulness, meditation, and yoga. |
| Brain Health Education | Active comparator | Behavioral: Brain Health Education8-week Brain Health education class that teaches participants about brain-behavior relationships, nutrition, aging facts, sleep, and memory. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- history of a single, chronic right or left hemisphere stroke
- native English proficiency
- at least mild level of depression
- and/or mild anxiety
- language within normal limits
Key exclusion criteria (8 listed)
- a pre-morbid neurologic history or history of schizophrenia spectrum and other psychotic disorders
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based Stress ReductionAlso: MBSR8-week Mindfulness-based Stress Reduction class that trains participants in mindfulness, meditation, and yoga. | Behavioural | Mindfulness-based Stress Reduction (MBSR) |
| Brain Health Education8-week Brain Health education class that teaches participants about brain-behavior relationships, nutrition, aging facts, sleep, and memory. | Behavioural | Brain Health Education |
Primary outcome
State-Trait Anxiety Inventory
Time frame: 10 weeks
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.
1 secondary outcome
Geriatric Depression Scale - 30
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36398589Lwi SJ, Paulraj SR, Schendel K, Dempsey DG, Curran BC, Herron TJ, Baldo JV. A Randomized, Controlled Pilot Study of Mindfulness-Based Stress Reduction in Healthy Older Adults. Clin Gerontol. 2023 May-Jun;46(3):330-345. doi: 10.1080/07317115.2022.2137075. Epub 2022 Nov 18.
- Derived from this study: PubMed 41490301Lwi SJ, Chok J, Schendel K, Herron TJ, Curran BC, Baldo JV. A randomized controlled trial of online mindfulness-based stress reduction in chronic stroke. Rehabil Psychol. 2026 Aug;71(3):404-416. doi: 10.1037/rep0000651. Epub 2026 Jan 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliana V. Baldo, PhD principal investigator
VA Northern California Health Care System, Mather, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Stress Reduction and Brain Health Education in people with Stroke, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03969563, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.