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

Primary Biliary Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05374200
• Other study ID #: Pro00112622
• Status: Completed
• Phase: N/A
• Start date: October 3, 2021
• Est. completion date: April 9, 2022

Study information

• Verified date: July 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: April 9, 2022
• Est. primary completion date: April 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cholangitis
• Liver Cirrhosis, Biliary
• Primary Biliary Cirrhosis

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HADS Anxiety and Depression Scale	Depression and anxiety will be measured on the Hospital Anxiety and Depression Scale. The minimum score is 0, the maximum score is 21, and higher scores indicate a worse outcome.	Baseline to 12 weeks
Secondary	PBC-40	Six PBC specific quality of life domains will be measured on the PBC-40. For each question, the minimum value is 1, the maximum value is 5, and higher scores indicates a worse outcome. The overall scoring range varies among domains.	Baseline to 12 weeks
Secondary	Perceived Stress Scale	The degree to which situations in one's life are appraised as stressful will be assessed using the Perceived Stress Scale. The minimum score is 0, the maximum score is 40, and higher scores indicate a worse outcome.	12 Weeks
Secondary	Modified Fatigue Impact Scale	The effect of fatigue on cognitive, physical, and psychosocial functioning will be measured with the modified fatigue impact scale. The minimum score is 0, the maximum score is 36, and higher scores indicate a worse outcome.	12 Weeks
Secondary	Connor Davidson Resilience Scale 10	Resilience will be measured on the Connor Davidson Resilience Scale 10. The minimum score is 0, the maximum score is 40, and higher scores indicate a better outcome.	12 Weeks
Secondary	Lower Extremity Function Scale	Ability to perform every day tasks will be measured on the Lower Extremity Function Scale. The minimum score is 0, the maximum score is 80, and lower scores indicate worse outcomes.	12 Weeks
Secondary	Capability, Opportunity, Motivation, Behavior (COM-B) Survey	Capability, opportunity, and motivation for behavior change will be measured on the COM-B survey. The minimum score is 0, the maximum score is 60, and higher scores indicate better outcomes.	12 Weeks