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Principal Investigator: GRETCHEN L HAAS
Organization: VETERANS HEALTH ADMINISTRATION
Fiscal Year: 2024
Funding agency: Veterans Affairs
This is a Hybrid 1, effectiveness-implementation study of yoga-based exercise (YE) as an adjunctive tool for
rehabilitation among persons with Severe Mental Illness (SMI), defined here as schizophrenia (SZ),
schizoaffective disorder (SZA) and bipolar I disorder (BP1). SMIs are common, severe and devastating
conditions that cause enormous disability world-wide. Many features of SMI can be treated effectively, yet the
long-term outcome has not improved much over the past century. The lack of improvement may be due to
ineffective treatment of functional deficits in SMI patients, particularly in terms of community functioning,
defined here as social, leisure, employment, and life skills functioning in the community. Complementary
and Integrative Medicine (CIM) therapies that improve community functions are thus of great interest for treating
Veterans with SMI and thereby target an area of high priority for the VA. Prior studies have shown short-term
benefits of YE for improving cognitive deficits and community functions among persons with SMI. While the
published studies are encouraging, the longer-term benefits of YE are untested, particularly for community
functioning. The profile of Veterans with SMI who will accept and adopt YE is also unknown. We have
conducted pilot studies and a randomized controlled trial (RCT) for individuals with SMI in India using short-term,
simplified YE combined with medications. Recently, we also concluded RELIEVE, a RCT of adjunctive YE for
Veterans with post-traumatic stress disorder (PTSD) in the USA (VA RR&D Merit award, PI: L Davis, PsyD). We
found encouraging improvements from all our studies, but our Indian and US YE protocols are impractical for
Veterans with SMI. For example, some postures may be difficult for older Veterans with amotivation and/or
physical disabilities. Therefore, in Aim 1, we will design and evaluate adaptations of the Indian and US YE
protocols in a non-religious context (mindfulness, stretching, toning and breathing exercises). We will consult our
Indian and US colleagues, our Veterans with SMI and their VA therapists to adapt the protocol for our SMI
population. We will also adapt our control condition, the Wellness Lifestyle Program (WLP), from our recently
completed RELIEVE study. In Aim 2, we 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 (TAU, any prescribed treatment) or WLP+
TAU. Unlike prior short-term YE RCTs, the two arms will continue 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 refresher training sessions offered for the remaining 6 months. We
will conform to all COVID-19 related requirements for YE and WLP. Our Hybrid 1 trial will compare the efficacy
of YE versus WLP. Primary outcomes are self-report and performance-based measures of community
functioning; secondary outcomes are cognition and physical fitness measures. Our goals in Aim 3 are 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 (Aim 3A). We 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). The project thus aims to advance our
long-term goals for improving the quality of life for Veterans with SMI and to provide evidence to guide home-
based and over the longer term, community-based YE practice, consistent with the Mission Act and the VA
Strategic Plan. Our experience in conducting a variety of SMI research for over 25 years offers strong support
for successful completion of the proposal.
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