Exercise-based Program for Rehabilitation of Veterans With Severe Mental Illness
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
🗓️ Study Start (Actual) 24 October 2022
🗓️ Primary Completion (Estimated) 27 February 2026
✅ Study Completion (Estimated) 27 February 2026
👥 Enrollment (Estimated) 140
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Pittsburgh, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion 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

    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
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 1 December 2021
  • First Submitted that Met QC Criteria 1 December 2021
  • First Posted 15 December 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 19 October 2023
  • Last Update Posted 23 October 2023
  • Last Verified October 2023