Mindfulness-Based Stress Reduction to Improve Neuropsychological Functioning in Acquired Brain Injury

January 22, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Brain Health Education
8-week Brain Health education class that teaches participants about brain-behavior relationships, nutrition, aging facts, sleep, and memory.
Behavioral: Brain Health Education
8-week Brain Health education class that teaches participants about brain-behavior relationships, nutrition, aging facts, sleep, and memory.
Experimental: Mindfulness-based Stress Reduction (MBSR)
8-week Mindfulness-based Stress Reduction class that trains participants in mindfulness, meditation, and yoga.
Behavioral: Mindfulness-based Stress Reduction
8-week Mindfulness-based Stress Reduction class that trains participants in mindfulness, meditation, and yoga.
Other Names:
  • MBSR

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Geriatric Depression Scale - 30
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 30, with 0 being no/minimal depression and 20-30 being severe depression. A lower score 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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Juliana V. Baldo, PhD, VA Northern California Health Care System, Mather, CA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 5, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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