Yoga-based exercise program for veterans with severe mental illness
Exercise-based Program for Rehabilitation of Veterans With Severe Mental Illness
This study tests whether a yoga-based exercise program can help veterans with severe mental illness improve their daily functioning and overall well-being compared to a standard wellness program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05157620 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a yoga-based exercise (YE) program as a rehabilitation tool for veterans diagnosed with severe mental illness, including schizophrenia, schizoaffective disorder, and bipolar disorder. It is a randomized controlled trial comparing YE to a Wellness Lifestyle Program (WLP) over a 12-month period, focusing on community functioning, cognition, and physical fitness. The study aims to adapt existing yoga protocols for veterans and assess factors influencing engagement and implementation of the program.
Who should consider this trial
Good fit: Ideal candidates are veterans aged 18-65 with a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder who are clinically stable.
Not a fit: Patients with severe intellectual disabilities or those unable to participate in yoga-based exercises due to physical limitations may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could improve community functioning and overall well-being for veterans with severe mental illness.
How similar studies have performed: Previous studies have shown promising results for yoga and exercise interventions in mental health, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Pittsburgh, Pennsylvania
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Vishwajit Laxmikant Nimgaonkar, MD PhD — VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
- Study coordinator: Vishwajit L Nimgaonkar, MD PhD
- Email: Vishwajit.Nimgaonkar@va.gov
- Phone: (412) 688-6000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.