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DepressionWPBINCT02600637

Wellness Programs for Brain-Injured Individuals

A study testing MBSR and Brain Health class in people with Depression and Anxiety, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Depression, Anxiety, Stroke
What is being tested?
MBSR and Brain Health class
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
1 Nov 2015to 30 Jun 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Northern California Health Care System, Mather, CA

    Sacramento, California, 95655

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
MBSR, Brain Health class
Keywords
stroke, depression, anxiety, mindfulness, meditation
Medical subject headings
Depression, Anxiety Disorders, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MBSRBehavioural

    Also called Meditation

    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.

  • Brain Health classBehavioural

    Also called Psychoeducation

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

Study groups in NCT02600637
Study groupRoleWhat they receive
MBSRExperimentalMindfulness-based Stress Reduction program
Receives: Behavioral: MBSR
EducationActive comparatorEducational group program
Receives: Behavioral: Brain Health class

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depression Score Change on Geriatric Depression Scale

    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.

    Measured: Over the 8 week assessment period for each participant, up to a total of 5 months

  2. Anxiety Score Change on State-Trait Anxiety Inventory Questionnaire

    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.

    Measured: Over the 8 week assessment period for each participant, up to a total of 5 months

Secondary outcomes (1)
  1. Repeatable Battery for Assessment of Neuropsychological Status Battery Overall Cognitive Change Score

    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.

    Measured: Over the 8 week assessment period for each participant, up to a total of 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2015 (estimated)
  2. Study start1 Nov 2015
  3. Primary completion10 Apr 2018
  4. Study completion30 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02600637
Sponsor's protocol ID
D1893-P
Acronym
WPBI
Status last verified
Jul 2019
First submitted
4 Nov 2015
Last updated
24 Jul 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing MBSR and Brain Health class in people with Depression and Anxiety, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.

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