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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Depression, Anxiety, Stroke
- 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 group | Role | What they receive |
|---|---|---|
| MBSR | Experimental | Mindfulness-based Stress Reduction program Receives: Behavioral: MBSR |
| Education | Active comparator | Educational group program Receives: Behavioral: Brain Health class |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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.
- First posted9 Nov 2015 (estimated)
- Study start1 Nov 2015
- Primary completion10 Apr 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Juliana V. Baldo, PhD, Principal investigator, VA Northern California Health Care System, Mather, CA
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Wellness Programs for Brain-Injured Individuals
- ClinicalTrials.gov ID
- NCT02600637
- Acronym / sponsor ID
- WPBI / D1893-P
- Conditions
- Depression, Anxiety, Stroke
- Keywords
- stroke, depression, anxiety, mindfulness, meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 9 Nov 2015 (estimated)
- Results
- Posted 1 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBSR | Experimental | Behavioral: MBSRMindfulness-based Stress Reduction program |
| Education | Active comparator | Behavioral: Brain Health classEducational group program |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBSRAlso: MeditationMindfulness-based Stress Reduction is an 8-week course designed to teach a number of mindfulness techniques to help improve stress- and depression-related symptoms. | Behavioural | MBSR |
| Brain Health classAlso: PsychoeducationAn 8-week course on brain health will be administered to participants as an active control group. | Behavioural | Education |
Primary outcome
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.
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliana V. Baldo, PhD principal investigator
VA Northern California Health Care System, Mather, CA
1 site in 1 country: see every site and its status.
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.