Primary Biliary Cirrhosis Clinical Trial
Official title:
A Randomized Control Trial Evaluating the Impact of a 12-week Mind-body Wellness Intervention in Patients With Primary Biliary Cholangitis (PBC)
Verified date | July 2022 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators have designed a guided, online, multicomponent, mind-body intervention for participants with primary biliary cholangitis. The ability of the online intervention to impact the primary and secondary outcome measures will be assessed as compared to control.
Status | Completed |
Enrollment | 87 |
Est. completion date | April 9, 2022 |
Est. primary completion date | April 9, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults (= 18 years) - Identified diagnosis of PBC - Ability to communicate (read, write, speak) in English - Access to an internet connected device at home. Exclusion Criteria: - Inability to provide informed consent - Unsafe to participate in a low-intensity online activity program (e.g. uncontrolled angina or arrhythmia, myocardial infarction or stroke within the last 3 month, other major medical comorbidity of concern) - Severe psychiatric disorders (HADS score >10) |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HADS Anxiety and Depression Scale | Depression and anxiety will be measured on the Hospital Anxiety and Depression Scale. The minimum score is 0, the maximum score is 21, and higher scores indicate a worse outcome. | Baseline to 12 weeks | |
Secondary | 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 higher scores indicates a worse outcome. The overall scoring range varies among domains. | Baseline to 12 weeks | |
Secondary | 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. | 12 Weeks | |
Secondary | 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 score is 0, the maximum score is 36, and higher scores indicate a worse outcome. | 12 Weeks | |
Secondary | Connor Davidson Resilience Scale 10 | Resilience will be measured on the Connor Davidson Resilience Scale 10. The minimum score is 0, the maximum score is 40, and higher scores indicate a better outcome. | 12 Weeks | |
Secondary | Lower Extremity Function Scale | Ability to perform every day tasks will be measured on the Lower Extremity Function Scale. The minimum score is 0, the maximum score is 80, and lower scores indicate worse outcomes. | 12 Weeks | |
Secondary | Capability, Opportunity, Motivation, Behavior (COM-B) Survey | Capability, opportunity, and motivation for behavior change will be measured on the COM-B survey. The minimum score is 0, the maximum score is 60, and higher scores indicate better outcomes. | 12 Weeks |
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