NCT05157620 · VA Office of Research and Development
Exercise-based Program for Rehabilitation of Veterans With Severe Mental Illness
(ESHANTI)
What this study 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-treatment group$1 randomly assigned controlled trial will compare the effectiveness of YE compared to the Wellness Lifestyle Program (WLP).
View original scientific description
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.
Interventions
OTHER
Yoga-based Exercise (YE)
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.
OTHER
Wellness Lifestyle Program (WLP)
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.
Primary outcome measures
Social Functioning Scale (SFS)
Time frame: 12 months
The Social Functioning Scale (SFS) is a self-report measure of social functioning, and is widely used in adults with psychosis.
Patient-Reported Outcomes Measurements Information Systems (PROMIS)
Time frame: 12 months
Patient-Reported Outcomes Measurements Information System's (PROMIS) Satisfaction with Participation in Social Roles and Activities will be used to assess participant's perceived satisfaction with their social roles and activities as part of the community and social functioning outcome. The PROMIS scale is an 8-item short form. The scale for each item is: Not at all, a little bit, somewhat, quite a bit, very much.
Quality of Life Scale (QOL)
Time frame: 12 months
The Quality of Life Scale (QOL) will be used to measure interpersonal, social and occupational functioning. The QOL scale is a 16-item scale ranging from 1-7. 1= Terrible, 2 = Unhappy, 3 = Mostly dissatisfied, 4= Mixed, 5 = Mostly satisfied, 6 = Pleased, 7= Delighted
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.,
- 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
- Pittsburgh, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations