Exercise-based Program for Rehabilitation of Veterans With Severe Mental Illness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorVA Office of Research and Development
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent;
age 18-70 years;
DSM-5 diagnosis of
schizophrenia,
Disqualifiers
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),
Trial design
Design model
Parallel
Treatments tested in this trial
Yoga-based Exercise (YE)
Other interventionThe 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.
Wellness Lifestyle Program (WLP)
Other interventionThe 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.
Treatment groups
112 Participants
are divided into 2 treatment groupsGroup A: Yoga-based Exercise (YE)Experimental treatment 1 intervention
Group B: Wellness Lifestyle Program (WLP)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 months2
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.
Time frame
12 months3
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
Time frame
12 monthsSecondary outcomes
1
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.
Time frame
12 months2
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. The investigators are still negotiating as of this date (10/18/2023), and so are not removing it from the registration. The investigators are adding another measure to take it's place if the investigators 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.
Time frame
12 month3
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.
Time frame
12 months4
Patterns of utilization
Virtual and paper logs will be used to assess patterns of YE/WLP utilization, difficulty, and satisfaction.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov