NCT04791527

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Primary Biliary Cirrhosis

Interventions

Type	Name	Description
BEHAVIORAL	Mind-body therapy	Online yoga, meditation, behavior change tips, and nutrition tips

Timeline

• Start date: 2021-02-14
• Primary completion: 2023-12-09
• Completion: 2023-12-31
• First posted: 2021-03-10
• Last updated: 2024-01-18

Locations

1 site across 1 country: Canada