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Clinical Trials/NCT04791527
NCT04791527
Completed
Not Applicable

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

University of Alberta1 site in 1 country34 target enrollmentFebruary 14, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Primary Biliary Cirrhosis
Sponsor
University of Alberta
Enrollment
34
Locations
1
Primary Endpoint
Perceived Stress Scale
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 14, 2021
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Perceived Stress Scale

Time Frame: 12 Weeks

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.

Secondary Outcomes

  • Connor Davidson Resilience Scale 10(12 Weeks)
  • HADS Anxiety and Depression Scale(12 Weeks)
  • PBC-40(12 Weeks)
  • Modified Fatigue Impact Scale(12 Weeks)
  • Capability, Opportunity, Motivation, Behavior (COM-B) Survey(12 Weeks)

Study Sites (1)

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