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

Learn more about:
Related Clinical Trial
Mind-body Wellness Intervention in Primary Biliary Cholangitis (PBC) A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Patients With PBC Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis National Database on Primary Biliary Cholangitis Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness Study of Obeticholic Acid(OCA) Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC) An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI) A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome PBC Induced Fatigue Treated With Thiamine Online Wellness Intervention for Primary Biliary Cholangitis (PBC) A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis Clinical Research of Reducing Medication Regimen for Ursodeoxycholic Acid in Treatment of Stable Primary Biliary Cholangitis RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA) Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation for Children Suffering From Biliary Atresia Bezafibrate in Patients With Primary Biliary Cholangitis (PBC) Gut Microbes and Metabolic Group in Different PBC Patients for UDCA Response Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic Acid Canadian Network for Autoimmune Liver Disease sCD163 in PBC Patients – Assessment of Disease Severity and Prognosis sCD163 in PBC Patients – Assessment of Treatment Response Effect of Obeticholic Acid on Transport of Bile Acids in PBC Examined by 11C-cholyl-sarcosine PET/CT Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine EXerCise Intervention in cholesTatic LivEr Disease: The EXCITED Study Fuzhenghuayu in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid Pilot Study of FFP104 Dose Escalation in PBC Subjects Clinical Trial on the Effect of the Sublimated Mare Milk Supplement on Primary Biliary Cholangitis A Study of TQA3526 in the Treatment of Primary Biliary Cirrhosis (PBC) Probiotics in PBC Patients of Poor Response to UDCA Identification of Inflammatory and Fibrotic Biomarkers in PBC and NAFLD Patients Combination Antiretroviral Therapy (cART) for PBC The Health Burden of Primary Biliary Cirrhosis (PBC) in Switzerland Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard Therapy Nalfurafine Hydrochloride for Pruritus in Patients With Primary Biliary Cholangitis Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Subjects With Primary Biliary Cirrhosis Ursodeoxycholic Acid Plus Budesonide Versus Ursodeoxycholic Acid Alone in Primary Biliary Cirrhosis (PBC) Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal Antibody Early Identification of Myocardial Impairment in PBC Stem Cell Transplantation in Patients With Primary Biliary Cirrhosis Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis (PBC) Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid Performance of Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I) A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune Hepatitis Safety and Efficacy of Long-Term Treatment With Atorvastatin in Patients With Primary Biliary Cirrhosis Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosis A Post-Authorisation Non-Interventional Observational of Patients in France With Primary Biliary Cholangitis Treated With Obeticholic Acid in Real Life A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA Study to Assess Safety and Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid. Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary Cirrhosis The Comparison About the Response of Ursodeoxycholic Acid in Primary Biliary Cholangitis Only and Primary Biliary Cholangitis With High Immune Globulin G or Aminotransferase at West China Hospital B-Cell Depleting Therapy (Rituximab) as a Treatment for Fatigue in Primary Biliary Cirrhosis Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis Study to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC) A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis Pentoxifylline for Primary Biliary Cirrhosis Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid Highly Active Antiretroviral Therapy for Patients With Primary Biliary Cirrhosis Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary Cirrhosis Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosis Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Patients With Primary Biliary Cholangitis Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC) A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis Mindfulness – Based Intervention in the Treatment of Fatigue in Patients With Primary Biliary Cholangitis Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary Cirrhosis Use of Fenofibrate for Primary Biliary Cirrhosis Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary Cirrhosis ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) Umbilical Cord Mesenchymal Stem Cells for Patients With Primary Biliary Cirrhosis Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis Genetic Epidemiology of Primary Biliary Cirrhosis (PBC) Initial Study of Rituximab to Treat Primary Biliary Cirrhosis Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders Moexipril for Primary Biliary Cirrhosis High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis Mesenchymal Stem Cell Transplantation for Refractory Primary Biliary Cholangitis Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) Study of Combivir for Patients With Primary Biliary Cirrhosis

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