Wellness Programs for Brain-Injured Individuals
| Status: | Completed |
|---|---|
| Conditions: | Anxiety, Anxiety, Depression, Neurology |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 20 - 80 |
| Updated: | 7/19/2018 |
| Start Date: | November 1, 2015 |
| End Date: | June 30, 2018 |
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.
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.
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.
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.
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
We found this trial at
1
site
Sacramento, California 95655
Principal Investigator: Juliana V. Baldo, PhD
Phone: 916-843-7195
Click here to add this to my saved trials
