Primary Biliary Cholangitis (PBC)NCT06861465
eMPower Mechanisms
A study testing Online Mind-Body Wellness Program and Online Mind-Body Wellness Program + Nutritional Counselling in people with Primary Biliary Cholangitis (PBC), run by University of Alberta at 1 site in Canada.
Trial summary
Primary Biliary Cholangitis (PBC) is a chronic liver disease that can cause fatigue, itching, brain fog, and emotional distress, all of which can lower quality of life. While the standard treatment, ursodeoxycholic acid (UDCA), helps slow the disease, it does not relieve these symptoms. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Primary Biliary Cholangitis (PBC)
- What is being tested?
- Online Mind-Body Wellness Program and Online Mind-Body Wellness Program + Nutritional Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 21 Feb 2025to 16 Jul 2025
- 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 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Biliary Cholangitis (PBC) as confirmed by a study Hepatologist using accepted clinical criteria
- Have been on stable medical therapy for PBC for ≥3 months
- Score ≥3 on a 1-10 numeric rating scale for two of: depression, anxiety, fatigue, sleep disturbance, cognitive impairment
- Are able to communicate in English
- Have access to an Internet-connected device in their home
- Can commit to up to 60 minutes of study activities 5 days per week
Who cannot join
- Unable to provide informed consent
- Have decompensated cirrhosis including hepatic encephalopathy
- Are post-liver transplant
- Current severe substance use or psychiatric disorder judged to interfere with study testing or program participation
- Are receiving compassionate care
- Have a clinical condition that makes the intervention unsafe or infeasible (e.g. unable to follow instruction) or unsafe environment for virtual participation
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- Practices mind-body practices more than the study dose
- Have contraindications for MRI
- Have colour blindness
- Are unable to attend baseline testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: eMPower Mechanisms: an Evidence-based Mental Wellness Programming Online for People With Primary Biliary Cholangitis - A Feasibility Randomized Controlled Trial
Primary Biliary Cholangitis (PBC) is a chronic liver disease that can cause fatigue, itching, brain fog, and emotional distress, all of which can lower quality of life. While the standard treatment, ursodeoxycholic acid (UDCA), helps slow the disease, it does not relieve these symptoms. Research shows that mind-body practices-such as breathing exercises, meditation, and gentle movement-can help improve mental and physical well-being in people with chronic conditions, but their benefits for PBC are not yet well understood.
This study will test a 10-week online wellness program designed for women with PBC. The program will include guided breathing, meditation, and movement exercises, plus optional weekly group sessions and educational videos. Some participants will also receive nutrition guidance on the Mediterranean diet to see if it adds extra benefits.
Read more
The study will evaluate feasibility via recruitment, adherence, and retention. To assess acceptability, participants will provide feedback through surveys and interviews. The study will also explore early signs of effectiveness by measuring changes in symptoms like anxiety, depression, fatigue, and stress, as well as biological markers, brain activity, physical function, and data from wearable devices.
The results will help determine whether an online mind-body program, with or without nutrition support, could be a simple and effective way to help people with PBC manage their symptoms and improve their quality of life.
- Conditions
- Primary Biliary Cholangitis (PBC)
- Being tested
- Online Mind-Body Wellness Program, Online Mind-Body Wellness Program + Nutritional Counselling
- Keywords
- Mind Body Wellness, Quality of Life, Fatigue, Cognitive Function, Physical Function, Mental Health
- Medical subject headings
- Liver Cirrhosis, Biliary, Fatigue, Psychological Well-Being
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)
Online Mind-Body Wellness Program + Nutritional CounsellingBehavioural
Online program (mindful movement, meditation, breathwork) + nutrition counselling
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Online Mind-Body Program | Active comparator | Online program (mindful movement, meditation, breathwork) Receives: Behavioral: Online Mind-Body Wellness Program |
| Experimental: Online Mind-Body Program + Nutritional Counselling | Experimental | Online program (mindful movement, meditation, breathwork) + nutritional counselling Receives: Behavioral: Online Mind-Body Wellness Program + Nutritional Counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Intervention
Feasibility will be assessed by (i) adherence rate (percentage completing ≥70% of intervention, target ≥70%), and (ii) retention rate (percentage completing baseline and follow-up assessments, target ≥70%).
Measured: Baseline and Week 10
Acceptability of the Intervention
Acceptability will be assessed via participant-reported satisfaction with the intervention using numerical surveys and perceived burden of study measures.
Measured: Baseline and Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start21 Feb 2025
- Primary completion16 Jul 2025
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary Cholangitis (PBC)Studies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861465
- Sponsor's protocol ID
- Pro00144631
- Status last verified
- May 2026
- First submitted
- 24 Feb 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eMPower Mechanisms: an Evidence-based Mental Wellness Programming Online for People With Primary Biliary Cholangitis - A Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06861465
- Acronym / sponsor ID
- Pro00144631
- Conditions
- Primary Biliary Cholangitis (PBC)
- Keywords
- Mind Body Wellness, Quality of Life, Fatigue, Cognitive Function, Physical Function, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 6 Mar 2025 (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.
Primary Biliary Cholangitis (PBC) is a chronic liver disease that can cause fatigue, itching, brain fog, and emotional distress, all of which can lower quality of life. While the standard treatment, ursodeoxycholic acid (UDCA), helps slow the disease, it does not relieve these symptoms. Research shows that mind-body practices-such as breathing exercises, meditation, and gentle movement-can help improve mental and physical well-being in people with chronic conditions, but their benefits for PBC are not yet well understood.
This study will test a 10-week online wellness program designed for women with PBC. The program will include guided breathing, meditation, and movement exercises, plus optional weekly group sessions and educational videos. Some participants will also receive nutrition guidance on the Mediterranean diet to see if it adds extra benefits.
The study will evaluate feasibility via recruitment, adherence, and retention. To assess acceptability, participants will provide feedback through surveys and interviews. The study will also explore early signs of effectiveness by measuring changes in symptoms like anxiety, depression, fatigue, and stress, as well as biological markers, brain activity, physical function, and data from wearable devices.
The results will help determine whether an online mind-body program, with or without nutrition support, could be a simple and effective way to help people with PBC manage their symptoms and improve their quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Online Mind-Body Program | Active comparator | Behavioral: Online Mind-Body Wellness ProgramOnline program (mindful movement, meditation, breathwork) |
| Experimental: Online Mind-Body Program + Nutritional Counselling | Experimental | Behavioral: Online Mind-Body Wellness Program + Nutritional CounsellingOnline program (mindful movement, meditation, breathwork) + nutritional counselling |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary Biliary Cholangitis (PBC) as confirmed by a study Hepatologist using accepted clinical criteria
- Have been on stable medical therapy for PBC for ≥3 months
- Score ≥3 on a 1-10 numeric rating scale for two of: depression, anxiety, fatigue, sleep disturbance, cognitive impairment
- Are able to communicate in English
- Have access to an Internet-connected device in their home
Key exclusion criteria (10 listed)
- Unable to provide informed consent
- Have decompensated cirrhosis including hepatic encephalopathy
- Are post-liver transplant
- Current severe substance use or psychiatric disorder judged to interfere with study testing or program participation
- Are receiving compassionate care
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) | Behavioural | Experimental: Online Mind-Body Program |
| Online Mind-Body Wellness Program + Nutritional CounsellingOnline program (mindful movement, meditation, breathwork) + nutrition counselling | Behavioural | Experimental: Online Mind-Body Program + Nutritional Counselling |
Primary outcome
Feasibility of the Intervention
Time frame: Baseline and Week 10
Feasibility will be assessed by (i) adherence rate (percentage completing ≥70% of intervention, target ≥70%), and (ii) retention rate (percentage completing baseline and follow-up assessments, target ≥70%).
Acceptability of the Intervention
Time frame: Baseline and Week 10
Acceptability will be assessed via participant-reported satisfaction with the intervention using numerical surveys and perceived burden of study measures.
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 11 May 2026.
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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 + Nutritional Counselling in people with Primary Biliary Cholangitis (PBC), 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 6 inclusion and 10 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 11 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?
Feasibility of the Intervention (time frame: Baseline and Week 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2026.