Primary Biliary CholangitisEMPOwerNCT05786482
Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical Conditions
A study testing Online mind-body wellness program and Online mind-body wellness program + Weekly Check-ins in people with Primary Biliary Cholangitis and Heart Failure, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Biliary Cholangitis, Heart Failure, Digestive Diseases
- What is being tested?
- Online mind-body wellness program and Online mind-body wellness program + Weekly Check-ins
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 825 participants
- Where
- 1 siteCanada
- Study dates
- 12 Feb 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical Conditions (EMPOwer) Randomized Controlled Trial
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
- Primary Biliary Cholangitis, Heart Failure, Digestive Diseases, Women Who Have Experienced a Cardiac Event, Cirrhosis, Liver, Post-Transplant
- Being tested
- Online mind-body wellness program, Online mind-body wellness program + Weekly Check-ins
- Keywords
- Mind Body Wellness, Depression, Anxiety, Quality of Life, Wellbeing, Yoga, Meditation, Psychology
- Medical subject headings
- Liver Cirrhosis, Biliary, Heart Failure, Digestive System Diseases, Liver Cirrhosis, Neoplasms, Renal Insufficiency, Chronic, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online mind-body wellness programBehavioural
Online program (mindful movement, meditation, breathwork, psychology-based coping skills program)
Online mind-body wellness program + Weekly Check-insBehavioural
Online program (mindful movement, meditation, breathwork, psychology-based coping skills program) + brief weekly check-ins
| Study group | Role | What they receive |
|---|---|---|
| Waitlist Control | No intervention | Not described |
| Online Program | Experimental | Online program (mindful movement, meditation, breathwork, psychology-based coping skills program) Receives: Behavioral: Online mind-body wellness program |
| Online Program + Weekly Check-ins | Experimental | Online program (mindful movement, meditation, breathwork, psychology-based coping skills program) + brief 1-to-1 weekly check-ins with a study team member Receives: Behavioral: Online mind-body wellness program + Weekly Check-ins |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start12 Feb 2023
- Primary completion22 Sep 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary Biliary CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 825 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786482
- Sponsor's protocol ID
- Pro00122568
- Acronym
- EMPOwer
- Status last verified
- May 2026
- First submitted
- 9 Mar 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the primary manuscript
Publications
Johnson 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.
PubMed 42623335Tiles-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.
PubMed 40243391Johnson 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.
PubMed 39079613
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical Conditions (EMPOwer) Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05786482
- Acronym / sponsor ID
- EMPOwer / Pro00122568
- Conditions
- Primary Biliary Cholangitis, Heart Failure, Digestive Diseases, Women Who Have Experienced a Cardiac Event, Cirrhosis, Liver, Post-Transplant
- Keywords
- Mind Body Wellness, Depression, Anxiety, Quality of Life, Wellbeing, Yoga, Meditation, Psychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 825 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 12 Feb 2023 (actual)
- Primary completion
- 22 Sep 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Waitlist Control | No intervention | – |
| Online Program | Experimental | Behavioral: Online mind-body wellness programOnline program (mindful movement, meditation, breathwork, psychology-based coping skills program) |
| Online Program + Weekly Check-ins | Experimental | Behavioral: Online mind-body wellness program + Weekly Check-insOnline program (mindful movement, meditation, breathwork, psychology-based coping skills program) + brief 1-to-1 weekly check-ins with a study team member |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online mind-body wellness programOnline program (mindful movement, meditation, breathwork, psychology-based coping skills program) | Behavioural | Online Program |
| Online mind-body wellness program + Weekly Check-insOnline program (mindful movement, meditation, breathwork, psychology-based coping skills program) + brief weekly check-ins | Behavioural | Online Program + Weekly Check-ins |
Primary outcome
Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 weeks
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.
5 secondary outcomes
Modified Fatigue Impact Scale (MFIS)
Time frame: 12 weeks
Health Related Quality of Life
Time frame: 12 weeks
EQ-5D-5L
Time frame: 12 weeks
Capability, Opportunity, Motivation, Behaviour (COM-B) Survey
Time frame: 12 weeks
Satisfaction and Adherence
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Derived from this study: PubMed 42623335Johnson 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.
- Derived from this study: PubMed 40243391Tiles-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.
- Derived from this study: PubMed 39079613Johnson 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the primary manuscript
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online mind-body wellness program and Online mind-body wellness program + Weekly Check-ins in people with Primary Biliary Cholangitis and Heart Failure, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (HADS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05786482, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.