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

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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia; Schizoaffective; Bipolar Disorder 1
• Intervention / Treatment: Other: Yoga-based Exercise (YE); Other: Wellness Lifestyle Program (WLP)

Detailed Description

This study will examine Yoga-based Exercise (YE) as a rehabilitation tool for Veterans with Severe Mental Illness (SMI), defined as schizophrenia (SZ), schizoaffective disorder (SZA), and Bipolar 1 disorder (BP1), with or without co-morbid history of alcohol use disorders (AUD) or substance use disorders (SUD). The study will evaluate factors associated with engagement in and uptake of YE among Veterans with SMI. This is a randomized controlled trial of YE that will examine factors that could facilitate or impede implementation of YE among Veterans with SMI.

Aim 1. Adapt YE protocols for Veterans with SMI. The investigators will design and evaluate adaptions of previously used Indian and US-based YE protocols in a non-religious context (mindfulness, stretching, toning and breathing exercises). The investigators will consult Indian and US colleagues, Veterans with SMI, and their VA therapists to adapt the protocol for SMI population. The investigators will also adapt control condition, the Wellness Lifestyle Program (WLP), from the recently completed RELIEVE study.

Aim 2. Study the efficacy of long-term YE among Veterans with SMI with a 2-armed RCT. The investigators will conduct a 2-armed RCT in which consenting Veterans with SMI will be randomly assigned to one of 2 arms: YE and treatment as usual or WLP and treatment as usual. Unlike prior short-term YE RCTs, the two arms will continue for 12 months, including an initial 12-week training period consisting of two supervised sessions per week, followed by a 12-week training period consisting of one supervised session per week and monthly sessions for the remaining 6 months. The investigators will compare the efficacy of YE versus WLP. The primary outcomes are self-report and performance-based measures of community functioning. Secondary outcomes are cognition and physical fitness measures.

Aim 3. Study factors associated with YE acceptance, adoption and implementation. The investigators goal for Aim 3 is to understand demographic/clinical features of Veterans with SMI who are more likely to accept and adopt YE to enable long-term rehabilitation, by analysis of the RCT data (Aim3A). 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).

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vishwajit L Nimgaonkar, MD PhD; Phone Number: 3579 (412) 688-6000; Email: Vishwajit.Nimgaonkar@va.gov
• Study Contact Backup: Name: Gretchen L Haas, PhD; Phone Number: (412) 360-2662; Email: Gretchen.Haas@va.gov

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15240
      • Recruiting
      • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
      • Contact: Vishwajit L Nimgaonkar, MD PhD; Phone Number: 3579 (412) 688-6000; Email: Vishwajit.Nimgaonkar@va.gov
      • Principal Investigator: Vishwajit Laxmikant Nimgaonkar, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcomes Measurements Information Systems (PROMIS)	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.	12 months
Quality of Life Scale (QOL)	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	12 months
Virtual Reality Functional Capacity Assessment Tool (VRFCAT)	NOTE: The VA and the copyright holder of this assessment have not come to an agreement allowing the study to purchase rights to use this measure. We are still negotiating as of this date (10/18/2023), and so are not removing it from ART. We are adding another measure to take it's place if we remain unable to procure it, called the Social Functioning Scale (SFS) . Community (social) functioning is the primary outcome measured from the VRFCAT. The Virtual Reality Functional Capacity Assessment Tool (VRFCAT) is a computerized measure that assesses functional capacity with the potential to demonstrate real-world functional improvements. The VRFCAT generates a composite score.	12 months
Social Functioning Scale (SFS)	The Social Functioning Scale (SFS) is a self-report measure of social functioning, and is widely used in adults with psychosis.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression-Severity (CGI-S)	Clinical Global Impression - Severity (CGI-S) will be used to assess participant's severity of illness. The scale is a 7-point scale. 0=Not Assessed, 1= Normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4= moderately ill, 5=markedly ill, 6= severely ill, 7= among most extremely ill.	12 months
Patterns of utilization	Virtual and paper logs will be used to assess patterns of YE/WLP utilization, difficulty, and satisfaction.	12 months
Brief Psychiatric Rating Scale (BPRS)	The Brief Psychiatric Rating Scale (BPRS) will be used to assess participant's severity of illness and assess level of depression, anxiety, and psychotic features. Items 1-10 are self report by the patient / participant. Items 11-18 are reported by the observer based on behaviors and speech. The scale ranges from 0 - 7. 0=Not assessed, 1= Not present, 2 = very mild, 3 = mild, 4= moderate, 5= moderately severe, 6= severe, 7= extremely severe	12 months
Brief Assessment of Cognition (BAC)	NOTE: The VA and the copyright holder of this assessment have not come to an agreement allowing the study to purchase rights to use this measure. We are still negotiating as of this date (10/18/2023), and so are not removing it from ART. We are adding another measure to take it's place if we remain unable to procure it, called The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The Brief Assessment of Cognition in schizophrenia scale will be used to evaluate domains of cognition that are most impaired and strongly correlated with outcome in patients with schizophrenia. The BAC is completed via a computerized program that generates a composite score.	12 month
2-minute walk	endurance/aerobic capacity will be assess by the 2-minute walk test, which measures the distance walked during a 2-minute interval.	12 months
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	The Repeatable Battery for the Assessment of Neuropsychological Status is a neuropsychological assessment consisting of twelve subtests which give five scores, one for each of the five domains tested (immediate memory, visuospatial/constructional, language, attention, delayed memory).	12 months
Multidimensional Assessment of Interoceptive Awareness, 2nd Edition (MAIA2)	The Multidimensional Assessment of Interoceptive Awareness, 2nd Edition (MAIA2) is a 37-item questionnaire assessing an individual's interoceptive awareness, which is the ability to perceive and understand signals and sensations from inside one's body. This questionnaire has good validity and reliability and is widely used in research.	12 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Vishwajit Laxmikant Nimgaonkar, MD PhD, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Estimated): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: exercise; quality of life; schizophrenia; yoga; psychotic disorders; schizoaffective; bipolar disorder 1; community function
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior; Schizophrenia; Psychotic Disorders; Motor Activity
• Other Study ID Numbers: D3622-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No