Clinical trial NCT05157620: Exercise-based Program for Rehabilitation of Veterans With Severe Mental Illness
Official title: Exercise-based Program for Rehabilitation of Veterans With Severe Mental Illness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Schizoaffective
Bipolar Disorder 1
Keywords: schizophrenia
psychotic disorders
schizoaffective
bipolar disorder 1
exercise
yoga
community function
quality of life
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-12-15
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial. Participants will be randomized to either a Yoga-based exercise intervention or a Wellness Lifestyle Program intervention. Both interventions will be conducted simultaneously.
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* Written informed consent;
* age 18-65 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;
  * no psychoactive medication changes for past 4 weeks;
* 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

Primary outcomes:
measure: Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
timeFrame: 12 months
measure: Patient-Reported Outcomes Measurements Information Systems (PROMIS)
timeFrame: 12 months
measure: Quality of Life Scale (QOL)
timeFrame: 12 months
measure: Social Functioning Scale (SFS)
timeFrame: 12 months
Secondary outcomes:
measure: Clinical Global Impression-Severity (CGI-S)
timeFrame: 12 months
measure: Brief Assessment of Cognition (BAC)
timeFrame: 12 month
measure: 2-minute walk
timeFrame: 12 months
measure: Patterns of utilization
timeFrame: 12 months
measure: Brief Psychiatric Rating Scale (BPRS)
timeFrame: 12 months
measure: The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: 12 months
measure: Multidimensional Assessment of Interoceptive Awareness, 2nd Edition (MAIA2)
timeFrame: 12 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Vishwajit Laxmikant Nimgaonkar, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: