Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical Conditions
EMPOwer
1 other identifier
interventional
825
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 12, 2023
CompletedFirst Submitted
Initial submission to the registry
March 9, 2023
CompletedFirst Posted
Study publicly available on registry
March 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJanuary 6, 2025
January 1, 2025
1.6 years
March 9, 2023
January 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Modified Fatigue Impact Scale (MFIS)
12 weeks
Health Related Quality of Life
12 weeks
EQ-5D-5L
12 weeks
Capability, Opportunity, Motivation, Behaviour (COM-B) Survey
12 weeks
Satisfaction and Adherence
12 weeks
Other Outcomes (5)
Demoralization (Exploratory)
12 weeks
Edmonton Frail Scale (Exploratory)
12 weeks
Fried Frailty (Exploratory)
12 weeks
- +2 more other outcomes
Study Arms (3)
Waitlist Control
NO INTERVENTIONOnline Program
EXPERIMENTALOnline program (mindful movement, meditation, breathwork, psychology-based coping skills program)
Online Program + Weekly Check-ins
EXPERIMENTALOnline program (mindful movement, meditation, breathwork, psychology-based coping skills program) + brief 1-to-1 weekly check-ins with a study team member
Interventions
Online program (mindful movement, meditation, breathwork, psychology-based coping skills program)
Online program (mindful movement, meditation, breathwork, psychology-based coping skills program) + brief weekly check-ins
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alberta
Edmonton, Alberta, T6G2X8, Canada
Related Publications (1)
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PMID: 40243391DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2023
First Posted
March 27, 2023
Study Start
February 12, 2023
Primary Completion
September 22, 2024
Study Completion
December 1, 2024
Last Updated
January 6, 2025
Record last verified: 2025-01