Clinical trial · Interventional
Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical Conditions
Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical Conditions (EMPOwer) Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Chronic Kidney Diseases | — | UNRESOLVED | — |
| Cirrhosis, Liver | — | UNRESOLVED | — |
| Digestive Diseases | — | UNRESOLVED | — |
| Heart Failure | — | UNRESOLVED | — |
| Other Chronic Physical Condition | — | UNRESOLVED | — |
| Post-Transplant | — | UNRESOLVED | — |
| Primary Biliary Cholangitis | — | UNRESOLVED | — |
| Women Who Have Experienced a Cardiac Event | — | UNRESOLVED |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Online mind-body wellness program | Behavioral | — | UNRESOLVED |
| Online mind-body wellness program + Weekly Check-ins | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Waitlist Control
- type
- EXPERIMENTAL
- label
- Online Program
- description
- Online program (mindful movement, meditation, breathwork, psychology-based coping skills program)
- interventionNames
- Behavioral: Online mind-body wellness program
- type
- EXPERIMENTAL
- label
- Online Program + Weekly Check-ins
- description
- Online program (mindful movement, meditation, breathwork, psychology-based coping skills program) + brief 1-to-1 weekly check-ins with a study team member
- interventionNames
- Behavioral: Online mind-body wellness program + Weekly Check-ins
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDJohnson E, Hyde A, Corrick S, Isley S, Wright G, Ezekowitz J, Zheng Y, Lee-Baggley D, Spiers J, Spence JC, McNeely ML, Thompson S, Ismond K, Tymchuk S, Tandon P. Effect of a digital intervention on mental health symptoms in adults with chronic conditions: A three-arm randomized controlled trial. PLoS Med. 2026 Aug 20;23(8):e1005198. doi: 10.1371/journal.pmed.1005198. eCollection 2026 Aug. PMID 42623335
- DERIVEDTiles-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 40243391
- DERIVEDJohnson E, Ismond K, Hyde A, Ezekowitz J, Wright G, Spiers J, Spence J, Thompson S, McNeely ML, Zheng Y, Round J, Tymchuk S, Lee-Baggley D, Isley S, Corrick S, Minckler H, Tandon P. eMPower: An online Mind-body wellness Program for adults living with chronic health conditions: A three-armed randomized controlled trial protocol. Contemp Clin Trials. 2024 Oct;145:107642. doi: 10.1016/j.cct.2024.107642. Epub 2024 Jul 28. PMID 39079613