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

University of Alberta

Status: Completed

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

Treatments: Behavioral: Online mind-body wellness program + Weekly Check-ins; Behavioral: Online mind-body wellness program

Study type: Interventional

Funder types: Other

Identifiers

NCT05786482

Pro00122568

Details and patient eligibility

About

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.

Enrollment: 825 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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825 participants in 3 patient groups

Waitlist Control

No Intervention group

Online Program

Experimental group

Description:

Online program (mindful movement, meditation, breathwork, psychology-based coping skills program)

Treatment:

Behavioral: Online mind-body wellness program

Online Program + Weekly Check-ins

Experimental group

Description:

Online program (mindful movement, meditation, breathwork, psychology-based coping skills program) + brief 1-to-1 weekly check-ins with a study team member

Treatment:

Behavioral: Online mind-body wellness program + Weekly Check-ins