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

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2022
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.
Epistemonikos ID: e26494371383ae30f629b81d514838e00f50f603
First added on: Dec 20, 2022