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

NCT03969563 | Completed Results

• 1 other identifier: D2951-R
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; MBSR; meditation; mindfulness; yoga

Outcome Measures

Primary Outcomes (1)

• 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.

  10 weeks

Secondary Outcomes (1)

• Geriatric Depression Scale - 30

  10 weeks

Study Arms (2)

Mindfulness-based Stress Reduction (MBSR)

EXPERIMENTAL

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

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.

Behavioral: Brain Health Education

Interventions

Mindfulness-based Stress Reduction BEHAVIORAL

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

Also known as: MBSR

Mindfulness-based Stress Reduction (MBSR)

Brain Health Education BEHAVIORAL

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

Brain Health Education

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• on Beck Depression Inventory-II94,95
• and/or mild anxiety
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Northern California Health Care System, Mather, CA

Sacramento, California, 95655-4200, United States

Location

Related Publications (2)

• 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.

  PMID: 36398589 RESULT

• Lwi 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 Jan 5:10.1037/rep0000651. doi: 10.1037/rep0000651. Online ahead of print.

  PMID: 41490301 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Jerry Nadler, Chief of Research
• Organization: VA Northern California Health Care System

Jerry.Nadler@va.gov

9168432776

Study Officials

• Juliana V. Baldo, PhD

  VA Northern California Health Care System, Mather, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The neuropsychologist doing the assessments pre- and post-intervention will not be aware of the participant's group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants are assigned to either the MBSR or Brain Health education class, in parallel for the duration of the study.

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: May 31, 2019
• Study Start: January 6, 2020
• Primary Completion: January 5, 2024
• Study Completion: January 15, 2024
• Last Updated: February 4, 2025
• Results First Posted: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)