NCT05157620Recruiting
Exercise-based Program for Rehabilitation of Veterans With Severe Mental Illness
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 112 (estimated)
- First submitted
- 1 Dec 2021
- Start date
- 24 Oct 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Schizophrenia, Bipolar disorder
- NCT number
- NCT05157620
What you commit to
- Study type: Interventional
- Planned participants: 112
- From 24 Oct 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
Other
- 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);
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.