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

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.

Conditions

Schizophrenia, Schizoaffective, Bipolar Disorder 1

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Schizophrenia
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA, Pittsburgh, Pennsylvania, United States, 15240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Written informed consent;
  • * age 18-65 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;
  • * no psychoactive medication changes for past 4 weeks;
  • * clinical global impression-severity (CGI-S) scores mild to moderately ill
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

VA Office of Research and Development,

Vishwajit Laxmikant Nimgaonkar, MD PhD, PRINCIPAL_INVESTIGATOR, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study Record Dates

2026-05-31