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Online Wellness Intervention for Primary Biliary Cholangitis (PBC)

U

University of Alberta

Status

Completed

Conditions

Primary Biliary Cirrhosis

Treatments

Behavioral: Mind-body therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04791527
Pro00106526

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

34 participants in 1 patient group

Mind-body Intervention arm
Experimental group
Description:
Online yoga, meditation, behavior change tips, and nutrition tips
Treatment:
Behavioral: Mind-body therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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