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

Overview

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.

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).

Interventions

• 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
• 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

Primary outcome measures

• Social Functioning Scale (SFS) [Time frame: 12 months]
• Patient-Reported Outcomes Measurements Information Systems (PROMIS) [Time frame: 12 months]
• Quality of Life Scale (QOL) [Time frame: 12 months]

Secondary outcome measures (8)

• Clinical Global Impression-Severity (CGI-S) [Time frame: 12 months]
• Brief Assessment of Cognition (BAC) [Time frame: 12 month]
• 2-minute walk [Time frame: 12 months]
• Patterns of utilization [Time frame: 12 months]
• Brief Psychiatric Rating Scale (BPRS) [Time frame: 12 months]
• The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [Time frame: 12 months]
• Multidimensional Assessment of Interoceptive Awareness, 2nd Edition (MAIA2) [Time frame: 12 months]
• RAND 36-Item Short Form Survey (SF-36) [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh

Identifiers

NCT: NCT05157620 · D3622-R

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗