NCT04791527

Online Wellness Intervention for Primary Biliary Cholangitis (PBC)

Completed NA Last updated 18 January 2024

What this trial tests

NA trial testing Mind-body therapy in Primary Biliary Cirrhosis in 34 participants. Completed in 31 December 2023.

Timeline

14 February 2021

Primary endpoint
9 December 2023

31 December 2023

Quick facts

Lead sponsor	University of Alberta
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	14 February 2021
Primary completion	9 December 2023
Estimated completion	31 December 2023
Sites	1 location across Canada

Drugs / interventions tested

• Mind-body therapy — full drug profile →

Conditions studied

• Primary Biliary Cirrhosis — all drugs for Primary Biliary Cirrhosis →

Sponsor

University of Alberta

Who can join

18 and older, any sex, with Primary Biliary Cirrhosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The feasibility and acceptability of an online mind-body wellness program for patients with primary biliary cholangitis.
   Watt M, Hyde A, Spence JC, Wright GM, et al · · 2023 · cited 6× · PMID 38020194 · DOI 10.3138/canlivj-2022-0045
2. Development of a Theoretically Informed Web-Based Mind-Body Wellness Intervention for Patients With Primary Biliary Cholangitis: Formative Study.
   Watt M, Spence JC, Tandon P. · · 2021 · cited 2× · PMID 34623317 · DOI 10.2196/29064