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Behavioural Intervention

Exercise Programs for Severe Mental Illness (ESHANTI Trial)

N/A
Recruiting
Led By Vishwajit Laxmikant Nimgaonkar, MD PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or bipolar 1 disorder including those with a co-morbid alcohol use disorder or substance use disorder
Age 18-65 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights

ESHANTI Trial Summary

This trial will compare the effectiveness of yoga-based exercises to the Wellness Lifestyle Program for rehabilitation among persons with Severe Mental Illness.

Who is the study for?
This trial is for veterans aged 18-65 with mild to moderately severe schizophrenia, schizoaffective disorder, or bipolar I disorder. Participants should be clinically stable and not have had medication changes in the last month. They must be able to do yoga-based exercises and cannot have severe physical disabilities, uncontrolled blood pressure issues, recent heart problems without doctor's permission, or certain neurological illnesses.Check my eligibility
What is being tested?
The study tests if yoga-based exercises can help rehabilitate veterans with Severe Mental Illness (SMI) better than a Wellness Lifestyle Program (WLP). It measures how well participants function in daily life activities like socializing and working. The study also looks at cognitive abilities and physical fitness as secondary outcomes.See study design
What are the potential side effects?
Since this trial involves exercise programs rather than medications, side effects are minimal but may include muscle soreness or strain from the physical activity involved in yoga-based exercises.

ESHANTI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar 1 disorder, and may also have an alcohol or substance use problem.
Select...
I am between 18 and 65 years old.
Select...
I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar 1.

ESHANTI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient-Reported Outcomes Measurements Information Systems (PROMIS)
Quality of Life Scale (QOL)
Social Functioning Scale (SFS)
+1 more
Secondary outcome measures
2-minute walk
Brief Assessment of Cognition (BAC)
Brief Psychiatric Rating Scale (BPRS)
+3 more

ESHANTI Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Yoga-based Exercise (YE)Experimental Treatment1 Intervention
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.
Group II: Wellness Lifestyle Program (WLP)Active Control1 Intervention
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.

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,622 Previous Clinical Trials
3,323,581 Total Patients Enrolled
17 Trials studying Bipolar Disorder
2,446 Patients Enrolled for Bipolar Disorder
Vishwajit Laxmikant Nimgaonkar, MD PhDPrincipal InvestigatorVA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Media Library

Wellness Lifestyle Program (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05157620 — N/A
Bipolar Disorder Research Study Groups: Yoga-based Exercise (YE), Wellness Lifestyle Program (WLP)
Bipolar Disorder Clinical Trial 2023: Wellness Lifestyle Program Highlights & Side Effects. Trial Name: NCT05157620 — N/A
Wellness Lifestyle Program (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05157620 — N/A
~70 spots leftby Feb 2026
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