Primary Biliary CirrhosisNCT05374200
Mind-body Wellness Intervention in Primary Biliary Cholangitis (PBC)
A study testing Mind-body intervention with 1-1 support from study personnel in people with Primary Biliary Cirrhosis, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Biliary Cirrhosis
- What is being tested?
- Mind-body intervention with 1-1 support from study personnel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteCanada
- Study dates
- 3 Oct 2021to 9 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥ 18 years)
- Identified diagnosis of PBC
- Ability to communicate (read, write, speak) in English
- Access to an internet connected device at home.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Control Trial Evaluating the Impact of a 12-week Mind-body Wellness Intervention in Patients With 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.
Read the 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.
- Conditions
- Primary Biliary Cirrhosis
- Being tested
- Mind-body intervention with 1-1 support from study personnel
- Keywords
- Mind Body Therapy, Yoga, Meditation, Behavior Change, Fatigue, Quality of Life, Stress, Depression, Anxiety
- Medical subject headings
- Liver Cirrhosis, Biliary, Fatigue, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-body intervention with 1-1 support from study personnelOther
Also called Mind-body intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 weeks
Secondary outcomes (6)
PBC-40
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.
Measured: Baseline to 12 weeks
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.
Measured: 12 Weeks
Modified Fatigue Impact Scale
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.
Measured: 12 Weeks
Connor Davidson Resilience Scale 10
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.
Measured: 12 Weeks
Lower Extremity Function Scale
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.
Measured: 12 Weeks
Capability, Opportunity, Motivation, Behavior (COM-B) Survey
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.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start3 Oct 2021
- Primary completion9 Apr 2022
- Study completion9 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Puneeta Tandon, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374200
- Sponsor's protocol ID
- Pro00112622
- Status last verified
- Jul 2022
- First submitted
- 1 Apr 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial Evaluating the Impact of a 12-week Mind-body Wellness Intervention in Patients With Primary Biliary Cholangitis (PBC)
- ClinicalTrials.gov ID
- NCT05374200
- Acronym / sponsor ID
- Pro00112622
- Conditions
- Primary Biliary Cirrhosis
- Keywords
- Mind Body Therapy, Yoga, Meditation, Behavior Change, Fatigue, Quality of Life, Stress, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 3 Oct 2021 (actual)
- Primary completion
- 9 Apr 2022 (actual)
- Study completion
- 9 Apr 2022 (actual)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Mind-body intervention with 1-1 support from study personnelParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (≥ 18 years)
- Identified diagnosis of PBC
- Ability to communicate (read, write, speak) in English
- Access to an internet connected device at home.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind-body intervention with 1-1 support from study personnelAlso: Mind-body interventionThe 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 | Intervention group |
Primary outcome
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.
6 secondary outcomes
PBC-40
Time frame: Baseline to 12 weeks
Perceived Stress Scale
Time frame: 12 Weeks
Modified Fatigue Impact Scale
Time frame: 12 Weeks
Connor Davidson Resilience Scale 10
Time frame: 12 Weeks
Lower Extremity Function Scale
Time frame: 12 Weeks
Capability, Opportunity, Motivation, Behavior (COM-B) Survey
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Puneeta Tandon principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-body intervention with 1-1 support from study personnel in people with Primary Biliary Cirrhosis, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HADS Anxiety and Depression Scale (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022; AzTrials last refreshed its copy on 31 Oct 2026.