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

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Primary biliary cirrhosis
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Brief Title

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

Official Title

A Randomized Control Trial Evaluating the Impact of a 12-week Mind-body Wellness Intervention in Patients With Primary Biliary Cholangitis (PBC)

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.

Detailed Description

      Persons with primary biliary cholangitis (PBC) experience significantly higher rates of
      fatigue, stress, anxiety, depression, and impaired health related quality of life (HRQOL) as
      compared to the general population. Online wellness programming ranging from physical
      activity to mindfulness interventions has been shown to be effective in decreasing fatigue
      and improving mental wellness in a variety of chronic disease populations. To date, no
      large-scale studies have been conducted to discern whether programming of this nature impacts
      measures of wellbeing in PBC.

      Building upon a 12-week, online, mind-body wellness program that our team previously
      co-developed with the Canadian PBC Society and launched as a feasibility and acceptability
      trial to a group of 30 individuals with PBC, the primary aim of this research project is to
      carry out a randomized controlled trial to assess the efficacy of the online intervention
      provided with brief study follow-up phone calls performed weekly by study personnel as
      compared to a control arm. The ability of the online program to impact the primary outcome
      measure of anxiety and depression as measured by the hospital anxiety and depression scale
      (HADS), and a range of secondary outcomes including perceived stress, fatigue, resilience,
      health related quality of life, physical functioning will be assessed as compared to control.

Study Type

Interventional

Primary Outcome

HADS Anxiety and Depression Scale

Secondary Outcome

 PBC-40

Condition

Primary Biliary Cirrhosis

Intervention

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

Study Arms / Comparison Groups

 Intervention group
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

86

Start Date

October 3, 2021

Completion Date

July 1, 2022

Primary Completion Date

July 1, 2022

Eligibility Criteria

        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)

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Puneeta Tandon, ,

Location Countries

Canada

Location Countries

Canada

Administrative Informations

NCT ID

NCT05374200

Organization ID

Pro00112622

Responsible Party

Sponsor

Study Sponsor

University of Alberta

Study Sponsor

Puneeta Tandon, Principal Investigator, University of Alberta

Verification Date

May 2022