Exercise Programs for Severe Mental Illness (ESHANTI Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Stay on your current meds
No Placebo Group
Trial Summary
What is the purpose of 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.
How is the Wellness Lifestyle Program treatment different from other treatments for severe mental illness?
The Wellness Lifestyle Program is unique because it integrates exercise as a key component of treatment for severe mental illness, addressing both physical and mental health by reducing risks associated with poor nutrition, low fitness, and inactivity, which are common in this population. Unlike traditional treatments that may focus solely on medication or therapy, this program emphasizes lifestyle changes to improve overall well-being and reduce premature mortality.
12458Is exercise safe for people with severe mental illness?
Exercise programs for people with severe mental illness are generally considered safe and can offer health benefits, but more research is needed to standardize reporting and assess any potential adverse events.
23578Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it requires that there have been no changes in psychoactive medications for the past 4 weeks. This suggests you should be stable on your current medications before joining.
What data supports the effectiveness of the treatment Wellness Lifestyle Program, Yoga-based Exercise, Yoga Therapy, and Mind-Body Exercise for severe mental illness?
Research shows that exercise and lifestyle interventions can improve physical health and reduce risks like heart disease and diabetes in people with severe mental illness. Exercise programs have been found to be feasible and can lead to positive changes in physical activity and well-being, although more research is needed to determine the best ways to deliver these programs.
23568Eligibility Criteria
This trial is for veterans aged 18-65 with mild to moderately severe schizophrenia, schizoaffective disorder, or bipolar I disorder. Participants should be clinically stable and not have had medication changes in the last month. They must be able to do yoga-based exercises and cannot have severe physical disabilities, uncontrolled blood pressure issues, recent heart problems without doctor's permission, or certain neurological illnesses.Inclusion Criteria
I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar 1 disorder, and may also have an alcohol or substance use problem.
I am between 18 and 65 years old.
I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar 1.
Exclusion Criteria
I am unable to participate in yoga or similar wellness activities due to physical issues.
I have a neurological condition like dementia, stroke, or head injury.
Participant Groups
The study tests if yoga-based exercises can help rehabilitate veterans with Severe Mental Illness (SMI) better than a Wellness Lifestyle Program (WLP). It measures how well participants function in daily life activities like socializing and working. The study also looks at cognitive abilities and physical fitness as secondary outcomes.
2Treatment groups
Experimental Treatment
Active Control
Group I: Yoga-based Exercise (YE)Experimental Treatment1 Intervention
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 will engage in yoga-based exercises once a month.
Group II: Wellness Lifestyle Program (WLP)Active Control1 Intervention
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 engage in WLP sessions once a week. The remainder of the study (6 months), participants will engage in WLP sessions once a month.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PAPittsburgh, PA
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
References
[Benefits of exercise for people with schizophrenia: a systematic review]. [2018]Previous reviews of exercise and mental health have predominantly examined chronic illness and more recently, several psychiatric disorders. There is growing evidence that exercise can also be an effective treatment for major depressive disorders, anxiety disorders and alcohol dependence. Individuals with schizophrenia are more likely to be sedentary than the general population.
An adjunct exercise program for serious mental illness: who chooses to participate and is it feasible? [2021]Despite evidence that exercise is beneficial for serious mental illness, it continues to be an under utilized adjunct treatment strategy. Thus, the aims of this study were to examine if self-selected or volunteer exercise programs are feasible in a structured outpatient program and who might choose to participate in such a program. Individuals with serious mental illness admitted to a partial hospital program were offered an adjunct exercise group or a control, psychoeducation group. The exercise group (N = 38) met three times a week for 50 min. Individuals who chose not to exercise (N = 28), attended a psychoeducational control group. Those who self-selected the exercise group tended to have a higher level of education, employment rate and to be Caucasian. The control group had more medical problems, a higher body mass index and alcohol intake. The groups did not differ on age, sex, or use of cigarettes and caffeine. The exercise group was regularly attended. Both groups improved equally on all outcomes symptom and psychological well-being outcomes. These data highlight that certain individuals with serious mental illness may be more likely to exercise based on demographic opposed to clinical features, or illness characteristics. Thus, adjunct exercise programs for individuals with serious mental illness seem to be feasible, but certain groups of individuals (i.e., ethnic minorities, unemployed) should be targeted for recruitment as they are less likely to volunteer for such adjunct exercise programs.
Exercise for mental illness: a systematic review of inpatient studies. [2018]A substantial body of evidence supports the role of exercise interventions for people with a mental illness. However, much of this literature is conducted using outpatient and community-based populations. We undertook a systematic review examining the effect of exercise interventions on the health of people hospitalized with depression, schizophrenia, bipolar disorder, or anxiety disorders. Eight studies met our inclusion criteria. Several studies show positive health outcomes from short-term and long-term interventions for people hospitalized due to depression. Although positive, the evidence for inpatients with schizophrenia, bipolar disorder, or anxiety disorders is substantially less. There is an urgent need to address the paucity of literature in this area, in particular the optimal dose and delivery of exercise for people hospitalized as a result of mental illness. Standardization of reporting exercise programme variables, the assessment of mental illness, and the reporting of adverse events must accompany future studies.
Increasing physical activity for veterans in the Mental Health Intensive Case Management Program: A community-based intervention. [2018]Individuals with severe mental illness (SMI), experience increased mortality-20 years greater disparity for men and 15 years greater disparity for women-compared to the general population (Thornicroft G. Physical health disparities and mental illness: The scandal of premature mortality. Br J Psychiatr. 2011;199:441-442). Numerous factors contribute to premature mortality in persons with SMI, including suicide and accidental death (Richardson RC, Faulkner G, McDevitt J, Skrinar GS, Hutchinson D, Piette JD. Integrating physical activity into mental health services for persons with serious mental illness. Psychiatr Serv. 2005;56(3):324-331; Thornicroft G. Physical health disparities and mental illness: The scandal of premature mortality. Br J Psychiatr. 2011;199:441-442), but research has shown that adverse health behaviors-including smoking, low rate of physical activity, poor diet, and high alcohol consumption-also significantly contribute to premature deaths (Jones J. Life expectancy in mental illness. Psychiatry Services. 2010. Retrieved from http://psychcentral.com/news/2010/07/13/life-expectancy-in-mental-illness). This quality improvement (QI) project sought to improve health and wellness for veterans in the Mental Health Intensive Case Management Program (MHICM), which is a community-based intensive program for veterans with SMI at risk for decompensation and frequent hospitalizations. At the time of this QI project, the program had 69 veterans who were assessed and treated weekly in their homes. The project introduced a pedometer steps intervention adapted from the VA MOVE! Program-a physical activity and weight management program-with the addition of personalized assistance from trained mental health professionals in the veteran's home environment. Because a large percentage of the veterans in the MHICM program had high blood pressure and increased weight, these outcomes were the focus of this project. Through mental health case management involvement and the comfort of their familiar living environment, veterans were assisted to meet their physical and mental health goals with a program that could easily be integrated into their daily lives.
Feasibility and Acceptability of a Student-Led Lifestyle (Diet and Exercise) Intervention Within a Residential Rehabilitation Setting for People With Severe Mental Illness, GO HEART (Group Occupation, Health, Exercise And Rehabilitation Treatment). [2022]People with severe mental illness (SMI) experience poor physical health and premature mortality, contributed significantly by modifiable lifestyle risk factors such as poor nutrition, low cardiorespiratory fitness, and physical inactivity. Lifestyle interventions can reduce cardiometabolic risk and confer a range of other positive mental and physical health benefits. We assessed the feasibility, acceptability, safety, and preliminary effectiveness of a lifestyle (combined dietary and exercise) intervention lead by senior exercise and dietetics students in a residential mental health rehabilitation setting.
Developing a Sound Body: Open Trial Results of a Group Healthy Lifestyle Intervention for Young Adults with Psychosis. [2021]The mortality disparity for persons with schizophrenia spectrum disorders (SSDs) due to cardiovascular disease is a devastating problem. Many risk factors are present in young adults with psychosis that may be ameliorated with lifestyle interventions. Sixteen participants with SSDs enrolled in an 11-week open trial of a novel lifestyle intervention comprised of group high intensity interval training exercise and health and wellness education. The aims were to evaluate (1) feasibility and (2) impact on sedentary behavior, physical activity, nutritional knowledge, physiological outcomes, and psychological well-being at end of intervention and 11-week follow-up. Attendance rates were 70% or higher for both intervention components and participants reported increased learning about healthy eating and exercise habits. Moderate to large effect sizes were observed for physical activity and sedentary behavior with sustained improvements in sedentary behavior at follow-up. Meaningful changes were not observed in other domains.
The Complex Interplay Between Physical Activity and Recovery Styles in Patients With Severe Mental Disorders in a Real-World Multicentric Study. [2022]Compared with the general population, people with severe mental disorders have significantly worse physical health and a higher mortality rate, which is partially due to the adoption of unhealthy lifestyle behaviors, such as heavy smoking, use of alcohol or illicit drugs, unbalanced diet, and physical inactivity. These unhealthy behaviors may also play a significant role in the personal and functional recovery of patients with severe mental disorders, although this relationship has been rarely investigated in methodologically robust studies. In this paper, we aim to: a) describe the levels of physical activity and recovery style in a sample of patients with severe mental disorders; b) identify the clinical, social, and illness-related factors that predict the likelihood of patients performing physical activity. The global sample consists of 401 patients, with a main psychiatric diagnosis of bipolar disorder (43.4%, N = 174), psychosis spectrum disorder (29.7%; N = 119), or major depression (26.9%; N = 118). 29.4% (N = 119) of patients reported performing physical activity regularly, most frequently walking (52.1%, N = 62), going to the gym (21.8%, N = 26), and running (10.9%, N = 13). Only 15 patients (3.7%) performed at least 75 min of vigorous physical activity per week. 46.8% of patients adopted sealing over as a recovery style and 37.9% used a mixed style toward integration. Recovery style is influenced by gender (p < 0.05) and age (p < 0.05). The probability to practice regular physical activity is higher in patients with metabolic syndrome (Odds Ratio - OR: 2.1; Confidence Interval - CI 95%: 1.2-3.5; p < 0.050), and significantly lower in those with higher levels of anxiety/depressive symptoms (OR: 0.877; CI 95%: 0.771-0.998; p < 0.01). Globally, patients with severe mental disorders report low levels of physical activities, which are associated with poor recovery styles. Psychoeducational interventions aimed at increasing patients' motivation to adopt healthy lifestyle behaviors and modifying recovery styles may improve the physical health of people with severe mental disorders thus reducing the mortality rates.
Effects of exercise on mortality rates of individuals with severe mental illness. [2022]Persons with severe mental illness have a 10-to-20-year shorter life span than the general public. Excess morbidity and mortality in this patient population has been described as a major public health challenge worldwide. Despite robust extant literature on the role of exercise in reducing morbidity and mortality, especially from cardiovascular disease and diabetes (highly prevalent in this patient population), Very few clinical programs or clinical research projects currently exist to implement and study the effects of exercise on decreasing morbidity and mortality in this highly vulnerable patient population. Given the global lack of trained mental health providers, the need to integrate healthcare providers from different disciplines, such as nurses, physical therapists, occupational therapists, physician assistants, cannot be overstated. This mini-review will provide an historic perspective and current data supporting the need to establish exercise, and other Lifestyle Psychiatry interventions, as a key component of treatment for all patients with serious mental illness.