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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
RECRUITING
Pittsburgh
Contact Information
Primary
Vishwajit L Nimgaonkar, MD PhD
Vishwajit.Nimgaonkar@va.gov
(412) 688-6000
Backup
Gretchen L Haas, PhD
Gretchen.Haas@va.gov
(412) 360-2662
Time Frame
Start Date: 2022-10-24
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 112
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov