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Online Wellness Intervention for Primary Biliary Cholangitis (PBC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04791527
Recruitment Status : Active, not recruiting
First Posted : March 10, 2021
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Primary Biliary Cirrhosis Behavioral: Mind-body therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 14, 2021
Estimated Primary Completion Date : May 9, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04791527


Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G2C8
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Puneeta Tandon University of Alberta
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT04791527    
Other Study ID Numbers: Pro00106526
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Alberta:
Mind Body Therapy
Stress
Quality of Life
Wellbeing
 Yoga
Meditation
Psychological
Additional relevant MeSH terms:
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Cholangitis
Liver Cirrhosis, Biliary
Fibrosis
Pathologic Processes
Bile Duct Diseases
Biliary Tract Diseases
 Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Liver Diseases
Liver Cirrhosis