Clinical trial NCT03969563: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
MBSR
meditation
mindfulness
yoga
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-05-31
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to either the MBSR or Brain Health education class, in parallel for the duration of the study.
Primary purpose: TREATMENT

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. 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.

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

Primary outcomes:
measure: State-Trait Anxiety Inventory
timeFrame: 10 weeks
Secondary outcomes:
measure: Geriatric Depression Scale - 30
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: VA Northern California Health Care System, Mather, CA
state: California
Study officials:
affiliation: VA Northern California Health Care System, Mather, CA
name: Juliana V. Baldo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.