NCT05374200

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

A Randomized Control Trial Evaluating the Impact of a 12-week Mind-body Wellness Intervention in Patients With Primary Biliary Cholangitis (PBC)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Primary Biliary Cirrhosis

Interventions

Type	Name	Description
OTHER	Mind-body intervention with 1-1 support from study personnel	The multicomponent intervention will consist of the following core components: (1) A choice between three different types of low-intensity, mindful movement videos - chair fitness, standing fitness, or standing tai chi (15-30 minutes/session); (2) Breathwork and theme-of-the-week based mindfulness meditations (5-10 minutes/session); (3) A once weekly positive psychology/behavior change activity presented as a point-and-click interactive storybook within the online site; (4) A once weekly disease management tip from a PBC physician. Weekly brief (\~10-minute) motivational interview style telephone check-ins taking place during the intervention period will be conducted by a member of the study team. During these check-ins, progress will be reviewed, motivation provided, and questions answered.

Timeline

• Start date: 2021-10-03
• Primary completion: 2022-04-09
• Completion: 2022-04-09
• First posted: 2022-05-16
• Last updated: 2022-08-03

Locations

1 site across 1 country: Canada