Clinical trial NCT06861465: EMPower Mechanisms
Official title: EMPower Mechanisms: an Evidence-based Mental Wellness Programming Online for People with Primary Biliary Cholangitis - a Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Biliary Cholangitis (PBC)
Keywords: Mind Body Wellness
Quality of Life
Fatigue
Cognitive Function
Physical Function
Mental Health
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Practices mind-body practices more than the study dose
* Have contraindications for MRI
* Have colour blindness
* Are unable to attend baseline testing

Primary outcomes:
measure: Feasibility of the Intervention
timeFrame: Baseline and Week 10
measure: Acceptability of the Intervention
timeFrame: Baseline and Week 10
Secondary outcomes:
Other outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline and Week 10
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Baseline and Week 10
measure: Primary Biliary Cholangitis-40 (PBC-40)
timeFrame: Baseline and Week 10
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline and Week 10
measure: Sleep Disturbance
timeFrame: Baseline and Week 10
measure: Cognitive Function
timeFrame: Baseline and Week 10
measure: Pain Interference
timeFrame: Baseline and Week 10
measure: Itch Interference
timeFrame: Baseline and Week 10
measure: Changes in Biological Markers
timeFrame: Baseline and Week 10
measure: Neurophysiological Changes
timeFrame: Baseline and Week 10
measure: Sit-to-stand
timeFrame: Baseline and Week 10
measure: The 2-Minute Step Test (2MST)
timeFrame: Baseline and Week 10
measure: Changes in Exercise Tolerance Mechanisms
timeFrame: Baseline and Week 10
measure: Changes in Wearable-Based Measures
timeFrame: Baseline and Week 10
measure: Change in Mediterranean diet score
timeFrame: Baseline and Week 10
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
References: