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NCT03969563Completed

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

Source: ClinicalTrials.gov · Last updated 4 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
110 (actual)
First submitted
29 May 2019
Start date
6 Jan 2020
Primary completion date
5 Jan 2024
Lead sponsor
VA Office of Research and Development
Diseases
Stroke
NCT number
NCT03969563

What you commit to

  • Study type: Interventional
  • Participants enrolled: 110
  • From 6 Jan 2020 to the primary completion date, 5 Jan 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • concurrent involvement in another rehabilitation program

Other illness

  • 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)

Other

  • acutely suicidal
  • significant visual or hearing disabilities that would preclude participating in the program

Who the study is looking for

  • 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

Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
VA Northern California Health Care System, Mather, CA
Coordinator of this site? Confirm its status
SacramentoUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.