Clinical trial NCT04791527: Online Wellness Intervention for Primary Biliary Cholangitis (PBC)
Official title: Assessing the Feasibility and Acceptability of a 12-week Online Stress Reduction/Wellness Intervention for Primary Biliary Cholangitis: a Pre-post Single-arm Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Biliary Cirrhosis
Keywords: Mind Body Therapy
Stress
Quality of Life
Wellbeing
Yoga
Meditation
Psychological
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary biliary cholangitis (PBC) is a chronic autoimmune condition of the liver. Persons with PBC have high rates of liver disease-related symptoms and poor health-related quality of life - amongst the lowest of all chronic liver diseases. Patients and the Canadian PBC Society have identified the need for self-care tools to manage symptom burden. Building upon a previously developed online wellness program for inflammatory bowel disease (IBD), the researchers have developed a mind-body wellness module specific for patients with PBC. The 12 week module will be delivered online, and each week is made of an introduction video, 15-20 minutes of yoga, 10-15 minutes of meditation, behavior change tips, and nutrition tips. In a pre-post single arm feasibility study, the researchers will assess how acceptable this module is to patients through looking at rates of refusal, completion rates, and patient feedback. At the beginning and the end of the 12-week research study, participants will complete surveys to assess exploratory outcome measures including stress, anxiety, depression, resilience, quality of life, fatigue, and perceived ability to participate in the 12 week module. After the program, the research team will conduct interviews with participants to allow them to share their other feedback about the program. The researchers will also send surveys to the participants one month after the program ends to asses their continued satisfaction with and adherence to the program.


Eligibility criteria: Inclusion Criteria:

* Adults (≥18 years)
* Identified diagnosis of PBC
* HADS score \<=10
* English language proficiency to complete questionnaires and read the educational material
* Access to the Internet and a computer or smart device at home.

Exclusion Criteria:

* Patients with a major medical co-morbidity
* Inability to provide informed written consent
* Severe psychiatric disorders (HADS scores \>10)

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: 12 Weeks
Secondary outcomes:
measure: HADS Anxiety and Depression Scale
timeFrame: 12 Weeks
measure: PBC-40
timeFrame: 12 Weeks
measure: Modified Fatigue Impact Scale
timeFrame: 12 Weeks
measure: Connor Davidson Resilience Scale 10
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:
citation: Watt M, Spence JC, Tandon P. Development of a Theoretically Informed Web-Based Mind-Body Wellness Intervention for Patients With Primary Biliary Cholangitis: Formative Study. JMIR Form Res. 2021 Oct 8;5(10):e29064. doi: 10.2196/29064.