Exercise-based Program for Rehabilitation of Veterans With Severe Mental Illness
Recruiting · NCT05157620 · Interventional (participants receive a specific treatment) · Lead sponsor: VA Office of Research and Development
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed across 1 US state.
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA - Pittsburgh, Pennsylvania, United States