Clinical trial NCT05374200: Mind-body Wellness Intervention in Primary Biliary Cholangitis (PBC)
Official title: A Randomized Control Trial Evaluating the Impact of a 12-week Mind-body Wellness Intervention in Patients With Primary Biliary Cholangitis (PBC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Biliary Cirrhosis
Keywords: Mind Body Therapy
Yoga
Meditation
Behavior Change
Fatigue
Quality of Life
Stress
Depression
Anxiety
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: HADS Anxiety and Depression Scale
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: PBC-40
timeFrame: Baseline to 12 weeks
measure: Perceived Stress Scale
timeFrame: 12 Weeks
measure: Modified Fatigue Impact Scale
timeFrame: 12 Weeks
measure: Connor Davidson Resilience Scale 10
timeFrame: 12 Weeks
measure: Lower Extremity Function Scale
timeFrame: 12 Weeks
measure: Capability, Opportunity, Motivation, Behavior (COM-B) Survey
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Puneeta Tandon
role: PRINCIPAL_INVESTIGATOR
References: