An interventional study of Mind-body therapy in Primary Biliary Cirrhosis, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-18.
Sponsored by University of Alberta · Not applicable, Interventional, and Treatment
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.
228 studies on the registry are indexed under Cholangitis; 32 are open to participants now.
This study's enrollment of 34 is below the median of 56 across 150 interventional studies indexed under Cholangitis.
Browse Cholangitis studies →University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Online yoga, meditation, behavior change tips, and nutrition tips
Behavioral: Mind-body therapy
Online yoga, meditation, behavior change tips, and nutrition tips
Perceived Stress Scale
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.
Time frame: 12 Weeks
HADS Anxiety and Depression Scale
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.
Time frame: 12 Weeks
PBC-40
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.
Time frame: 12 Weeks
Modified Fatigue Impact Scale
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.
Time frame: 12 Weeks
Connor Davidson Resilience Scale 10
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.
Time frame: 12 Weeks
Capability, Opportunity, Motivation, Behavior (COM-B) Survey
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.
Time frame: 12 Weeks
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Alberta