Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04791527
Study type Interventional
Source University of Alberta
Contact
Status Completed
Phase N/A
Start date February 14, 2021
Completion date December 31, 2023

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04526665 - Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) Phase 3
Recruiting NCT02931513 - sCD163 in PBC Patients - Assessment of Treatment Response
Active, not recruiting NCT02924701 - sCD163 in PBC Patients - Assessment of Disease Severity and Prognosis
Completed NCT02659696 - Nalfurafine Hydrochloride for Pruritus in Patients With Primary Biliary Cholangitis
Completed NCT02078882 - Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis Phase 4
Completed NCT01603199 - High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis N/A
Completed NCT01389973 - A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid Phase 2
Completed NCT01857284 - Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis Phase 3
Completed NCT05374200 - Mind-body Wellness Intervention in Primary Biliary Cholangitis (PBC) N/A
Recruiting NCT02937012 - Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders Phase 3
Completed NCT02376335 - B-Cell Depleting Therapy (Rituximab) as a Treatment for Fatigue in Primary Biliary Cirrhosis Phase 2
Recruiting NCT01662973 - Umbilical Cord Mesenchymal Stem Cells for Patients With Primary Biliary Cirrhosis Phase 1/Phase 2
Active, not recruiting NCT04751188 - A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis Phase 3
Recruiting NCT04514965 - Bezafibrate in Patients With Primary Biliary Cholangitis (PBC)
Recruiting NCT03668145 - Mesenchymal Stem Cell Transplantation for Refractory Primary Biliary Cholangitis N/A
Completed NCT02955602 - Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC) Phase 2
Completed NCT02557360 - Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary Cirrhosis Phase 4
Recruiting NCT01440309 - Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary Cirrhosis Phase 1
Completed NCT01249092 - Pentoxifylline for Primary Biliary Cirrhosis Phase 2
Completed NCT01510860 - Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis Phase 4