Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical Conditions

Study Overview
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Brief Summary
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Chronic physical conditions are deﬁned as conditions that require ongoing management and treatment over extended periods of time. Chronic physical conditions are not only leading causes of death and disability in North America but they are commonly associated with mental distress and reduced quality of life. Online mind-body wellness programming ranging from physical activity to mindfulness interventions has been shown to be effective in improving mental wellness in a variety of chronic disease populations, but there is a need to evaluate scalable ways to deliver these programs. Building upon a previously developed online wellness program for inﬂammatory bowel disease (IBD) and primary biliary cholangitis (PBC), the research team has developed a mind-body wellness program for adults ≥18 years of age living with different chronic conditions (e.g., cirrhosis, PBC, heart failure). The 12-week program will be delivered online, and include follow- along mindful movement, breathwork and meditation routines, and a psychology based coping skills program. In a three-armed randomized controlled trial, the study will assess the impact on the primary outcome of anxiety and depression as measured through the hospital anxiety and depression scale (HADS). At the beginning and the end of the 12-week research study, participants will complete surveys to assess secondary/exploratory outcome measures including quality of life, fatigue, frailty, demoralization, and healthcare usage. After the program, the research team will conduct interviews with participants to allow them to share their other feedback about the program. The researchers will also send surveys to the participants eight weeks after the program ends to assess longer- term impacts on primary and secondary outcomes.

Official Title
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Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical Conditions (EMPOwer) Randomized Controlled Trial

Conditions
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Primary Biliary Cholangitis, Heart Failure, Digestive Diseases, Women Who Have Experienced a Cardiac Event, Cirrhosis, Liver, Post-Transplant, Cancer, Chronic Kidney Diseases, Other Chronic Physical Condition

Intervention / Treatment
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* Behavioral: Online mind-body wellness program
* Behavioral: Online mind-body wellness program + Weekly Check-ins


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥18 years of age Identified diagnosis of one of nine chronic conditions (Heart Failure, PBC, Digestive Disease, Cirrhosis, Cancer survivor, Post-transplant, Women who have experienced a cardiac event, Chronic Kidney Disease), or another general category for physical chronic conditions not captured by these nine English language proficiency to complete questionnaires and read the educational material Access to the Internet and a computer or smart device at home Exclusion Criteria: Receiving compassionate care Inability to provide informed written consent Severe psychiatric disorders (presence of uncontrolled schizophrenia, post-traumatic stress disorder (PTSD), and/or bipolar disorder unless approved to participate by their physician/psychologist; suicidality nearly every day) No access to the internet

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Waitlist Control<br> | |
| Experimental: Online Program<br>Online program (mindful movement, meditation, breathwork, psychology-based coping skills program) | Behavioral: Online mind-body wellness program<br>* Online program (mindful movement, meditation, breathwork, psychology-based coping skills program)<br>|
| Experimental: Online Program + Weekly Check-ins<br>Online program (mindful movement, meditation, breathwork, psychology-based coping skills program) + brief 1-to-1 weekly check-ins with a study team member | Behavioral: Online mind-body wellness program + Weekly Check-ins<br>* Online program (mindful movement, meditation, breathwork, psychology-based coping skills program) + brief weekly check-ins<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS) | Depression and anxiety will be measured on the Hospital Anxiety and Depression Scale. The minimum value is 0, the maximum is 21, and higher scores mean a worse outcome. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Fatigue Impact Scale (MFIS) | The Modified Fatigue Impact Scale (MFIS) assesses the effect of fatigue on cognitive functioning, physical functioning, and psychosocial functioning. The minimum value is 0, the maximum value is 84, and higher scores mean a worse outcome. | 12 weeks | 
| Health Related Quality of Life | Health related quality of life captured by the quality-of-life Short Form Survey 12 (SF-12). The minimum value is 0, the maximum value is 100, and a higher score means a better outcome. | 12 weeks | 
| EQ-5D-5L | Cost utility analysis will be facilitated by the EQ-5D-5L which consists of 5- dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) where patients are asked to indicate their health state. The minimum value is 5, the maximum value is 25, and a higher score means a worse outcome. | 12 weeks | 
| Capability, Opportunity, Motivation, Behaviour (COM-B) Survey | Capability, opportunity, and motivation for behaviour change will be measured on the COM-B survey. The lowest score is 0, the highest score is 60, and higher scores indicate better outcomes. | 12 weeks | 
| Satisfaction and Adherence | Satisfaction and adherence will be measured using a self-report tool where participants indicate their satisfaction with program elements, and perceived adherence to the program over the study period. The minimum value is 4, the maximum value is 40, and a higher score means a better outcome. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mind Body Wellness, Depression, Anxiety, Quality of Life, Wellbeing, Yoga, Meditation, Psychology