NCT04791527Completed
Online Wellness Intervention for Primary Biliary Cholangitis (PBC)
Assessing the Feasibility and Acceptability of a 12-week Online Stress Reduction/Wellness Intervention for Primary Biliary Cholangitis: a Pre-post Single-arm Interventional Study
Source: ClinicalTrials.gov · Last updated 18 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Primary biliary cholangitis (PBC) is a chronic autoimmune condition of the liver. Persons with PBC have high rates of liver disease-related symptoms and poor health-related quality of life - amongst the lowest of all chronic liver diseases. Patients and the Canadian PBC Society have identified the need for self-care tools to manage symptom burden. Building upon a previously developed online wellness program for inflammatory bowel disease (IBD), the researchers have developed a mind-body wellness module specific for patients with PBC. The 12 week module will be delivered online, and each week is made of an introduction video, 15-20 minutes of yoga, 10-15 minutes of meditation, behavior change tips, and nutrition tips. In a pre-post single arm feasibility study, the researchers will assess how acceptable this module is to patients through looking at rates of refusal, completion rates, and patient feedback. At the beginning and the end of the 12-week research study, participants will complete surveys to assess exploratory outcome measures including stress, anxiety, depression, resilience, quality of life, fatigue, and perceived ability to participate in the 12 week module. 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 one month after the program ends to asses their continued satisfaction with and adherence to the program.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 8 Mar 2021
- Start date
- 14 Feb 2021
- Primary completion date
- 9 Dec 2023
- Lead sponsor
- University of Alberta
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT04791527
What you commit to
- Study type: Interventional
- Participants enrolled: 34
- From 14 Feb 2021 to the primary completion date, 9 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe psychiatric disorders (HADS scores \>10)
Other
- Patients with a major medical co-morbidity
- Inability to provide informed written consent
Who the study is looking for
- Adults (≥18 years)
- Identified diagnosis of PBC
- HADS score \<=10
- English language proficiency to complete questionnaires and read the educational material
- Access to the Internet and a computer or smart device at home.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.