Mind-body Wellness Intervention in Primary Biliary Cholangitis (PBC)

Status Completed

Clinical Trial Summary

The investigators have designed a guided, online, multicomponent, mind-body intervention for participants with primary biliary cholangitis. The ability of the online intervention to impact the primary and secondary outcome measures will be assessed as compared to control.

Clinical Trial Description

Persons with primary biliary cholangitis (PBC) experience significantly higher rates of fatigue, stress, anxiety, depression, and impaired health related quality of life (HRQOL) as compared to the general population. Online wellness programming ranging from physical activity to mindfulness interventions has been shown to be effective in decreasing fatigue and improving mental wellness in a variety of chronic disease populations. To date, no large-scale studies have been conducted to discern whether programming of this nature impacts measures of wellbeing in PBC. Building upon a 12-week, online, mind-body wellness program that our team previously co-developed with the Canadian PBC Society and launched as a feasibility and acceptability trial to a group of 30 individuals with PBC, the primary aim of this research project is to carry out a randomized controlled trial to assess the efficacy of the online intervention provided with brief study follow-up phone calls performed weekly by study personnel as compared to a control arm. The ability of the online program to impact the primary outcome measure of anxiety and depression as measured by the hospital anxiety and depression scale (HADS), and a range of secondary outcomes including perceived stress, fatigue, resilience, health related quality of life, physical functioning will be assessed as compared to control. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05374200
Study type	Interventional
Source	University of Alberta
Contact
Status	Completed
Phase	N/A
Start date	October 3, 2021
Completion date	April 9, 2022

View Details

See also
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