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

  • STATUS
    Recruiting
  • End date
    Apr 22, 2024
  • participants needed
    80
  • sponsor
    VA Office of Research and Development
Updated on 9 April 2022
aphasia
movement therapy

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.

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.

Details
Condition Stroke
Treatment Mindfulness-based stress reduction, Brain Health Education
Clinical Study IdentifierNCT03969563
SponsorVA Office of Research and Development
Last Modified on9 April 2022

Eligibility

Yes No Not Sure

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
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

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note