Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT05157620
Brief Summary:
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).
Study:
NCT05157620
Study Brief:
Protocol Section:
NCT05157620