Mind-body Wellness Intervention in Primary Biliary Cholangitis (PBC)

NCT05374200 | Completed

• 1 other identifier: Pro00112622
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Biliary Cirrhosis

Keywords

Mind Body Therapy; Yoga; Meditation; Behavior Change; Fatigue; Quality of Life; Stress; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• PBC-40

  Baseline to 12 weeks

• Perceived Stress Scale

  12 Weeks

• Modified Fatigue Impact Scale

  12 Weeks

• Connor Davidson Resilience Scale 10

  12 Weeks

• Lower Extremity Function Scale

  12 Weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants will receive the standard of care for PBC and access to the online intervention. During the intervention period, participants will also receive weekly brief (\~10-minute) motivational interview style telephone check-ins.

Other: Mind-body intervention with 1-1 support from study personnel

Wait list control group

NO INTERVENTION

During the 12-week wait list period, participants will receive the standard of care for PBC in addition to weekly emails with motivational messages.

Interventions

Mind-body intervention with 1-1 support from study personnel OTHER

The multicomponent intervention will consist of the following core components: (1) A choice between three different types of low-intensity, mindful movement videos - chair fitness, standing fitness, or standing tai chi (15-30 minutes/session); (2) Breathwork and theme-of-the-week based mindfulness meditations (5-10 minutes/session); (3) A once weekly positive psychology/behavior change activity presented as a point-and-click interactive storybook within the online site; (4) A once weekly disease management tip from a PBC physician. Weekly brief (\~10-minute) motivational interview style telephone check-ins taking place during the intervention period will be conducted by a member of the study team. During these check-ins, progress will be reviewed, motivation provided, and questions answered.

Also known as: Mind-body intervention

Intervention group

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
• Ability to communicate (read, write, speak) in English
• Access to an internet connected device at home.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G2C8, Canada

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary; Fatigue; Depression; Anxiety Disorders

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; Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Puneeta Tandon

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sealed envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: May 16, 2022
• Study Start: October 3, 2021
• Primary Completion: April 9, 2022
• Study Completion: April 9, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-07

Locations

CA (1)