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Completed

NCT Number: NCT05374200

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

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.

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Key information

Conditions

Primary Biliary Cirrhosis Anxiety Disorders Behavior Behavioral Symptoms Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Depression Digestive System Diseases Fatigue Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G2C8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Mind-body intervention

Primary outcomes

  1. HADS Anxiety and Depression Scale

    Time frame: Baseline to 12 weeks

    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.

Secondary outcomes

  1. PBC-40

    Time frame: Baseline to 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 higher scores indicates a worse outcome. The overall scoring range varies among domains.

  2. 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.

  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 score is 0, the maximum score is 36, and higher scores indicate 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 score is 0, the maximum score is 40, and higher scores indicate a better outcome.

  5. Lower Extremity Function Scale

    Time frame: 12 Weeks

    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.

  6. 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 minimum score is 0, the maximum score is 60, and higher scores indicate better outcomes.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 16, 2022
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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