Clinical trial NCT05786482: Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical Conditions
Official title: Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical Conditions (EMPOwer) Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Keywords: Mind Body Wellness
Depression
Anxiety
Quality of Life
Wellbeing
Yoga
Meditation
Psychology
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-03-27
Enrollment: 825
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: 12 weeks
measure: Health Related Quality of Life
timeFrame: 12 weeks
measure: EQ-5D-5L
timeFrame: 12 weeks
measure: Capability, Opportunity, Motivation, Behaviour (COM-B) Survey
timeFrame: 12 weeks
measure: Satisfaction and Adherence
timeFrame: 12 weeks
Other outcomes:
measure: Demoralization (Exploratory)
timeFrame: 12 weeks
measure: Edmonton Frail Scale (Exploratory)
timeFrame: 12 weeks
measure: Fried Frailty (Exploratory)
timeFrame: 12 weeks
measure: Healthcare Usage (Exploratory)
timeFrame: 12 weeks
measure: Sleep (Exploratory)
timeFrame: 12 weeks
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
References: