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

Primary Purpose

Stroke

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-based Stress Reduction
Brain Health Education
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, MBSR, meditation, mindfulness, yoga

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Northern California Health Care System, Mather, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MBSR

Brain Health Education

Arm Description

8-week Mindfulness-based Stress Reduction class that trains participants in mindfulness, meditation, and yoga.

8-week Brain Health education class that teaches participants about brain-behavior relationships, nutrition, aging facts, sleep, and memory.

Outcomes

Primary Outcome Measures

Beck Anxiety Inventory
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
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.

Secondary Outcome Measures

Beck Depression Inventory
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
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.

Full Information

First Posted
May 29, 2019
Last Updated
March 9, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03969563
Brief Title
Mindfulness-Based Stress Reduction to Improve Neuropsychological Functioning in Acquired Brain Injury
Official Title
Mindfulness-Based Stress Reduction to Improve Neuropsychological Functioning in Acquired Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
January 5, 2024 (Anticipated)
Study Completion Date
April 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, MBSR, meditation, mindfulness, yoga

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to either the MBSR or Brain Health education class, in parallel for the duration of the study.
Masking
Outcomes Assessor
Masking Description
The neuropsychologist doing the assessments pre- and post-intervention will not be aware of the participant's group assignment.
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MBSR
Arm Type
Experimental
Arm Description
8-week Mindfulness-based Stress Reduction class that trains participants in mindfulness, meditation, and yoga.
Arm Title
Brain Health Education
Arm Type
Active Comparator
Arm Description
8-week Brain Health education class that teaches participants about brain-behavior relationships, nutrition, aging facts, sleep, and memory.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based Stress Reduction
Other Intervention Name(s)
MBSR
Intervention Description
8-week Mindfulness-based Stress Reduction class that trains participants in mindfulness, meditation, and yoga.
Intervention Type
Behavioral
Intervention Name(s)
Brain Health Education
Intervention Description
8-week Brain Health education class that teaches participants about brain-behavior relationships, nutrition, aging facts, sleep, and memory.
Primary Outcome Measure Information:
Title
Beck Anxiety Inventory
Description
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.
Time Frame
10 weeks
Title
Working Memory Score on the Repeatable Battery for the Assessment of Neuropsychological Status
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
Description
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.
Time Frame
10 weeks
Title
Attention Score on the Repeatable Battery for the Assessment of Neuropsychological Status
Description
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.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliana V. Baldo, PhD
Organizational Affiliation
VA Northern California Health Care System, Mather, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Northern California Health Care System, Mather, CA
City
Sacramento
State/Province
California
ZIP/Postal Code
95655-4200
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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