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

University of Alberta

Status: Completed

Conditions: Primary Biliary Cirrhosis

Treatments: Other: Mind-body intervention with 1-1 support from study personnel

Study type: Interventional

Funder types: Other

Identifiers

NCT05374200

Pro00112622

Details and patient eligibility

About

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.

Full 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.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (≥ 18 years)
• Identified diagnosis of PBC
• Ability to communicate (read, write, speak) in English
• Access to an internet connected device at home.

Exclusion criteria

• Inability to provide informed consent
• Unsafe to participate in a low-intensity online activity program (e.g. uncontrolled angina or arrhythmia, myocardial infarction or stroke within the last 3 month, other major medical comorbidity of concern)
• Severe psychiatric disorders (HADS score >10)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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87 participants in 2 patient groups

Intervention group

Experimental group

Description:

Participants will receive the standard of care for PBC and access to the online intervention. During the intervention period, participants will also receive weekly brief (\~10-minute) motivational interview style telephone check-ins.

Treatment:

Other: Mind-body intervention with 1-1 support from study personnel

Wait list control group

No Intervention group

Description:

During the 12-week wait list period, participants will receive the standard of care for PBC in addition to weekly emails with motivational messages.