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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Online Mind-Body Program | Active Comparator | Online program (mindful movement, meditation, breathwork) |
|
| Experimental: Online Mind-Body Program + Nutritional Counselling | Experimental | Online program (mindful movement, meditation, breathwork) + nutritional counselling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online Mind-Body Wellness Program | Behavioral | Online program (mindful movement, meditation, breathwork) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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%). | 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. | Baseline and Week 10 |
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| Measure | Description | Time Frame |
|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) | Description: 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. | Baseline and Week 10 |
| Modified Fatigue Impact Scale (MFIS) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Edmonton | Alberta | T6G 2X8 | Canada |
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| ID | Term |
|---|---|
| D008105 | Liver Cirrhosis, Biliary |
| D005221 | Fatigue |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D002780 | Cholestasis, Intrahepatic |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
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| Online Mind-Body Wellness Program + Nutritional Counselling | Behavioral | Online program (mindful movement, meditation, breathwork) + nutrition counselling |
|
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. |
| Baseline and Week 10 |
| Primary Biliary Cholangitis-40 (PBC-40) | The PBC-40 assesses quality of life (HRQoL) in individuals with PBC. It consists of 40 items across six domains, assessing symptoms, fatigue, emotional well-being, cognitive function, social impact, and itch. | Baseline and Week 10 |
| Perceived Stress Scale (PSS) | The Perceived Stress Scale (PSS) assesses how unpredictable, uncontrollable, and overwhelming individuals find their lives. The scale is scored from 0 to 40. Higher scores indicate greater perceived stress. | Baseline and Week 10 |
| Sleep Disturbance | Sleep disturbance will be measured using the PROMIS Sleep Disturbance 6a. The scale ranges from 8 to 40. Higher scores indicate greater sleep disturbance. | Baseline and Week 10 |
| Cognitive Function | The PROMIS Short Form - Cognitive Function 6a will be used to assess cognitive function. The scale measures self-reported cognitive function on a scale from 6 to 30. Higher scores indicate better cognitive function. | Baseline and Week 10 |
| Pain Interference | Pain interference will be measured using the PROMIS Short Form - Pain Interference 4a. The measure assesses the impact of pain on daily activities on a scale from 4 to 20. Higher scores indicate greater pain interference. | Baseline and Week 10 |
| Itch Interference | Itch interference will be measured using the The PROMIS Short Form - Itch Interference 4a. The measure assesses the impact of itching on daily activities on a scale from 4 to 20. Higher scores indicate greater itch interference. | Baseline and Week 10 |
| Changes in Biological Markers | Blood sample analysis for biomarkers related to stress and inflammation Measure: Levels of stress, inflammation, and fatigue biomarkers (e.g., cortisol, cytokines) | Baseline and Week 10 |
| Neurophysiological Changes | Pre-post intervention changes in brain activity patterns Measure: fMRI and fNIRS measures of brain function | Baseline and Week 10 |
| Sit-to-stand | The Sit-to-Stand Test measures lower body strength and functional mobility by assessing the number of times an individual can rise from a seated position to a standing position within a set time or the time taken to complete a set number of repetitions. Higher repetitions in a given time or a shorter completion time indicate better functional performance. | Baseline and Week 10 |
| The 2-Minute Step Test (2MST) | The 2-Minute Step Test (2MST) measures aerobic endurance by counting the number of steps a person takes in place within 2 minutes, lifting the knees to a standardized height. Higher step counts indicate better endurance and functional fitness. | Baseline and Week 10 |
| Changes in Exercise Tolerance Mechanisms | Assessed using physiological testing for exercise tolerance. Measures: Non-invasive estimates of pulmonary oxygen uptake, skeletal muscle oxygenation | Baseline and Week 10 |
| Changes in Wearable-Based Measures | Collected via wearable devices to assess cardiovascular function. Measure: Heart rate variability | Baseline and Week 10 |
| Change in Mediterranean diet score | Assessed using dietary recall and adherence questionnaires. | Baseline and Week 10 |
| D004066 |
| Digestive System Diseases |
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |