Exercise-based Program for Rehabilitation of Veterans With Severe Mental Illness
VA Office of Research and Development
112 participants
Oct 24, 2022
INTERVENTIONAL
Conditions
Summary
This is a hybrid1, effectiveness-implementation study of yoga-based exercises (YE) as an adjunctive tool for rehabilitation among persons with Severe Mental Illness (SMI). The two-arm randomized controlled trial will compare the efficacy of YE compared to the Wellness Lifestyle Program (WLP). Primary outcomes of the study will be self-report and performance-based measures of community functioning, defined in the investigators study as social, leisure, employment, and life skills functioning in the community. Secondary outcomes will include cognition and physical fitness measures.
Eligibility
Inclusion Criteria10
- Written informed consent;
- age 18-70 years;
- DSM-5 diagnosis of
- schizophrenia,
- schizoaffective disorder,
- bipolar 1 disorder,
- DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or bipolar 1 disorder including those with a co-morbid
- alcohol use disorder or substance use disorder;
- clinically stable;
- clinical global impression-severity (CGI-S) scores mild to moderately ill
Exclusion Criteria12
- Unable to provide written informed consent;
- intellectual disability (i.e., severe enough to impact understanding of yoga-based exercises) based on chart or IQ\<80 on the Wechslet Abbreviated Scale of Intelligence-II (WASI-II);
- disability or illness precluding yoga-based exercises or wellness lifestyle program, e.g.,
- current or recent angina (\<6 months),
- history of myocardial infarction in the past year (unless permission is obtained from the primary care physician),
- uncontrolled hypertension or hypotension;
- neurological illness complicating diagnosis / cognitive evaluation, e.g.,
- dementia,
- stroke or head injury;
- physical problems that preclude training for yoga-based exercises / wellness lifestyle program, e.g.,
- severely impaired vision;
- ongoing treatment that includes more than one hour per week of relaxation and mind-body based stress reduction strategies related to yoga
Interventions
The Yoga-based Exercise (YE) intervention is a series of yoga-based poses that consists of sitting, standing, kneeling, and lying postures as well as breathing exercises. The duration of the intervention will be 12 months. Participants will engage in yoga-based exercise sessions lasting 60 minutes twice a week for the first 12 weeks (3 months) of the project. The following 12 weeks, participants will engage in yoga-based exercises once a week. The remainder of the study (6 months), participants will engage in yoga-based exercises once a month.
The Wellness Lifestyle Program (WLP) is a comprehensive lifestyle program that consists of 30 minutes of educational information covering various topics, such as nutrition, healthy living, stress reduction, and more will be followed by 30 minutes of low-intensity exercise such as walking. The duration of the intervention will be 12 months. Participants will engage in the 60 minute WLP session twice a week for the first 12 weeks (3 months) of the project. The following 12 weeks, participants will engage in WLP sessions once a week. The remainder of the study (6 months), participants will engage in WLP sessions once a month.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05157620