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Exercise-based Program for Rehabilitation of Veterans With Severe Mental Illness

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The investigators will also conduct qualitative interviews with Veterans who have SMI and participated in the YE intervention arm, referring clinicians, and the Yoga Instructor to identify barriers and facilitators for implementation (Aim 3b)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares yoga-based exercises with a wellness lifestyle program to help veterans with severe mental illness. It tests how well these programs help with social life, free-time activities, work, and daily living skills. It also looks at thinking skills and physical fitness.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 70 years old.
  • Understand the study and give written consent to join.
  • Have a diagnosis of schizophrenia, schizoaffective disorder, or bipolar 1 disorder.
  • People who also have an alcohol or drug use disorder may join.
  • Have a mental health condition that is stable, with symptoms rated mild to moderate.

Who can't join

  • Cannot give written consent to join.
  • Have an intellectual disability that makes it hard to understand the yoga exercises, based on medical records, or an IQ score below 80.
  • Have an illness or disability that prevents taking part in either program.
  • Have angina (heart-related chest pain) now or within the past 6 months.
  • Had a heart attack in the past year, unless a primary care doctor gives permission.
  • Have uncontrolled high or low blood pressure.
  • Have a brain or nerve condition, such as dementia, stroke, or a head injury, that makes diagnosis or testing thinking skills harder; or a physical problem, such as very poor vision, that prevents training.
  • Already receive more than 1 hour a week of treatment using relaxation and mind-body stress reduction methods related to yoga.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

PA