Online Wellness Intervention for Primary Biliary Cholangitis (PBC)

January 17, 2024 updated by: University of Alberta

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mind-body Intervention arm
Online yoga, meditation, behavior change tips, and nutrition tips
Behavioral: Mind-body therapy
Online yoga, meditation, behavior change tips, and nutrition tips

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HADS Anxiety and Depression Scale
Time Frame: 12 Weeks
Depression and anxiety will be measured on the Hospital Anxiety and Depression Scale. The minimum value is 0, the maximum is 21, and higher scores mean a worse outcome.
12 Weeks
PBC-40
Time Frame: 12 Weeks
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 5 indicates a worse outcome. The overall scoring range varies among domains.
12 Weeks
Modified Fatigue Impact Scale
Time Frame: 12 Weeks
The effect of fatigue on cognitive, physical, and psychosocial functioning will be measured with the modified fatigue impact scale. The minimum value is 0, the maximum value is 36, and higher scores mean a worse outcome.
12 Weeks
Connor Davidson Resilience Scale 10
Time Frame: 12 Weeks
Resilience will be measured on the Connor Davidson Resilience Scale 10. The minimum value is 0, the maximum value is 40, and higher scores indicate a better outcome.
12 Weeks
Capability, Opportunity, Motivation, Behavior (COM-B) Survey
Time Frame: 12 Weeks
Capability, opportunity, and motivation for behavior change will be measured on the COM-B survey. The lowest score is 0, the highest score is 60, and higher scores indicate better outcomes.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

  • Principal Investigator: Puneeta Tandon, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2021

Primary Completion (Actual)

December 9, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

March 8, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00106526

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe