Wellness Programs for Brain-Injured Individuals

NCT ID: NCT02600637

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-01
• Study Completion Date: 2018-06-30

Brief Summary

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 pilot study proposes to teach MBSR to a group of Veterans with a history of stroke to determine whether this type of intervention is feasible, acceptable to patients, and shows preliminary evidence of 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

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 sensory awareness. A handful of preliminary studies have shown that MBSR is effective in reducing symptoms of depression and anxiety 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 pilot study of MBSR in Veterans with a history of stroke, using an active control group, blinded examiners, and a 3-month follow-up session to determine whether any benefits of MBSR are long-lasting. For the study, 60 Veterans with a history of chronic stroke will be recruited: 30 patients will be randomly assigned to the MBSR intervention, and 30 patients will be assigned to a Brain Health education program, which will be matched to the MBSR group 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 (within 1 week), and 3) three months later. The investigators will evaluate a number of feasibility factors in this pilot study, including patient recruitment and retention procedures, effectiveness of randomization and blinding measures, and patient acceptability. Preliminary evaluation of the MBSR intervention will test for clinically reliable 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 also predicted that changes associated with the MBSR intervention will still be present at the 3-month follow-up assessment as well. The final objective of the current proposal is an exploratory aim 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, patients with and without left prefrontal involvement will be compared, and 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 successful, the investigators plan to execute a larger efficacy study to evaluate the magnitude of treatment effects associated with MBSR. Alternative interventions such as MBSR can provide low-cost, non-invasive rehabilitative treatments for chronic stroke that can improve Veterans' functional recovery and general sense of well-being.

Conditions

Depression; Anxiety; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MBSR

Mindfulness-based Stress Reduction program

Group Type: EXPERIMENTAL

MBSR

Intervention Type: BEHAVIORAL

Mindfulness-based Stress Reduction is an 8-week course designed to teach a number of mindfulness techniques to help improve stress- and depression-related symptoms.

Education

Educational group program

Group Type: ACTIVE_COMPARATOR

Brain Health class

Intervention Type: BEHAVIORAL

An 8-week course on brain health will be administered to participants as an active control group.

Interventions

MBSR

Mindfulness-based Stress Reduction is an 8-week course designed to teach a number of mindfulness techniques to help improve stress- and depression-related symptoms.

Intervention Type: BEHAVIORAL

Brain Health class

An 8-week course on brain health will be administered to participants as an active control group.

Intervention Type: BEHAVIORAL

Other Intervention Names

Meditation; Psychoeducation

Eligibility Criteria

Inclusion Criteria

• A history of a single, chronic right or left hemisphere stroke (> 6 months post-onset so that residual symptoms have stabilized)
• Age 20-80
• Native English proficiency
• At least mild level of depression and/or mild anxiety
• Language within normal limits 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
• Bipolar disorders
• Depressive disorders with psychotic features (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 (defined below)
• Concurrent involvement in another rehabilitation program
• Significant visual or hearing disabilities that would preclude participating in the program
• Medical history, including pre-morbid neurologic and psychiatric history, will be assessed with a standard medical questionnaire during the initial interview session as well as a review of patients' VA medical records
• Medications will not be an exclusionary factor for participation but will be recorded and tracked via VA computerized medical record systems

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juliana V. Baldo, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Northern California Health Care System, Mather, CA

Locations

VA Northern California Health Care System, Mather, CA

Sacramento, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

D1893-P

Identifier Type: -

Identifier Source: org_study_id