Wellness Programs for Brain-Injured Individuals (WPBI)

July 15, 2019 updated by: VA Office of Research and Development

Evaluation of Wellness Programs for Brain-Injured Individuals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95655
        • VA Northern California Health Care System, Mather, CA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MBSR
Mindfulness-based Stress Reduction program
Behavioral: 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.
Other Names:
  • Meditation
Active Comparator: Education
Educational group program
Behavioral: Brain Health class
An 8-week course on brain health will be administered to participants as an active control group.
Other Names:
  • Psychoeducation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Depression Score Change on Geriatric Depression Scale
Time Frame: Over the 8 week assessment period for each participant, up to a total of 5 months
Determine whether the MBSR treatment has any effect on depression by comparing change scores (post-intervention minus pre-intervention) on the Geriatric Depression Scale (GDS) for MBSR versus Education control group. A negative change score indicates improvement in depressive symptomatology. Full score range possible on the GDS is 0-30, where 0 means no depression and 30 means severe depression.
Over the 8 week assessment period for each participant, up to a total of 5 months
Anxiety Score Change on State-Trait Anxiety Inventory Questionnaire
Time Frame: Over the 8 week assessment period for each participant, up to a total of 5 months
Determine whether the MBSR treatment has any effect on anxiety by comparing change score (post-intervention minus pre-intervention) on State-Trait Anxiety Inventory (STAI) for MBSR versus Education control group. A negative change score indicates improvement in anxiety symptoms. Full range of scores on the STAI is 20-80, where 20 is minimal/no anxiety and 80 is severe anxiety.
Over the 8 week assessment period for each participant, up to a total of 5 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Repeatable Battery for Assessment of Neuropsychological Status Battery Overall Cognitive Change Score
Time Frame: Over the 8 week assessment period for each participant, up to a total of 5 months
Determine whether the MBSR treatment has any effect on overall cognitive performance by comparing the change score (post-intervention minus pre-intervention) in overall Cognitive standard score on RBANS for MBSR versus Education control group. Positive change score indicates improvement in overall cognitive performance. The possible range of standard scores on the RBANS is 40-154, where 40 is severely impaired cognition and 154 is superior range cognition.
Over the 8 week assessment period for each participant, up to a total of 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D1893-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings