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)

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.

Study Overview

• Status: Completed
• Conditions: Primary Biliary Cirrhosis
• Intervention / Treatment: Other: Mind-body intervention with 1-1 support from study personnel

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.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G2C8
      • University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group; 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.	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.; Other Names: Mind-body intervention
NO_INTERVENTION: Wait list control group; During the 12-week wait list period, participants will receive the standard of care for PBC in addition to weekly emails with motivational messages.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Alberta

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 3, 2021
• Primary Completion (ACTUAL): April 9, 2022
• Study Completion (ACTUAL): April 9, 2022

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (ACTUAL): May 16, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Depression; Quality of Life; Anxiety; Yoga; Stress; Fatigue; Meditation; Behavior Change; Mind Body Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Cholangitis; Liver Cirrhosis, Biliary
• Other Study ID Numbers: Pro00112622

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No