Online Wellness Intervention for Primary Biliary Cholangitis (PBC)

NCT04791527 | Completed

• 1 other identifier: Pro00106526
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Biliary Cirrhosis

Keywords

Mind Body Therapy; Stress; Quality of Life; Wellbeing; Yoga; Meditation; Psychological

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• HADS Anxiety and Depression Scale

  12 Weeks

• PBC-40

  12 Weeks

• Modified Fatigue Impact Scale

  12 Weeks

• Connor Davidson Resilience Scale 10

  12 Weeks

• Capability, Opportunity, Motivation, Behavior (COM-B) Survey

  12 Weeks

Study Arms (1)

Mind-body Intervention arm

EXPERIMENTAL

Online yoga, meditation, behavior change tips, and nutrition tips

Behavioral: Mind-body therapy

Interventions

Mind-body therapy BEHAVIORAL

Online yoga, meditation, behavior change tips, and nutrition tips

Mind-body Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with a major medical co-morbidity
• Inability to provide informed written consent
• Severe psychiatric disorders (HADS scores \>10)

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G2C8, Canada

Location

Related Publications (1)

• Watt M, Spence JC, Tandon P. Development of a Theoretically Informed Web-Based Mind-Body Wellness Intervention for Patients With Primary Biliary Cholangitis: Formative Study. JMIR Form Res. 2021 Oct 8;5(10):e29064. doi: 10.2196/29064.

  PMID: 34623317 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

Mind-Body Therapies

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Puneeta Tandon

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 10, 2021
• Study Start: February 14, 2021
• Primary Completion: December 9, 2023
• Study Completion: December 31, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

CA (1)