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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

Must not have

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

Neurological illness complicating diagnosis / cognitive evaluation, e.g., dementia, stroke or head injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar 1 disorder, and may also have an alcohol or substance use problem.

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I am between 18 and 65 years old.

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I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar 1.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to participate in yoga or similar wellness activities due to physical issues.

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I have a neurological condition like dementia, stroke, or head injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient-Reported Outcomes Measurements Information Systems (PROMIS)

Quality of Life Scale (QOL)

Social Functioning Scale (SFS)

+1 more

Secondary study objectives

2-minute walk

Brief Assessment of Cognition (BAC)

Brief Psychiatric Rating Scale (BPRS)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met