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Mind-Body Therapy for Primary Biliary Cholangitis
N/A
Waitlist Available
Led By Puneeta Tandon
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial is testing a 12-week online mind-body wellness module to help manage symptoms for people with primary biliary cholangitis, a chronic autoimmune condition of the liver. The module includes yoga, meditation, behavior change tips, and nutrition tips. They will assess how acceptable this module is to patients and if it helps with stress, anxiety, depression, resilience, quality of life, fatigue, and perceived ability to participate in the 12 week module.
Who is the study for?
This trial is for adults over 18 with Primary Biliary Cholangitis (PBC) who speak English and can access the internet. They should be able to understand educational materials, have a stable mental health status (HADS score <=10), and give informed consent. People with severe psychiatric disorders or major medical conditions cannot participate.Check my eligibility
What is being tested?
The study tests an online wellness program designed for PBC patients, which includes yoga, meditation, behavior change tips, and nutrition advice over 12 weeks. Participants will provide feedback on the program's acceptability through surveys before and after completion as well as one month later.See study design
What are the potential side effects?
Since this intervention involves mind-body therapy like yoga and meditation rather than medication, side effects are minimal but may include discomfort from new physical activities or emotional distress if personal issues arise during sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Perceived Stress Scale
Secondary outcome measures
Capability, Opportunity, Motivation, Behavior (COM-B) Survey
Connor Davidson Resilience Scale 10
HADS Anxiety and Depression Scale
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Mind-body Intervention armExperimental Treatment1 Intervention
Online yoga, meditation, behavior change tips, and nutrition tips
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mind-body therapy
2021
N/A
~100
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
886 Previous Clinical Trials
384,744 Total Patients Enrolled
Puneeta TandonPrincipal InvestigatorUniversity of Alberta
3 Previous Clinical Trials
276 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious existing health condition.You have severe mental health issues, as shown by a score greater than 10 on the HADS assessment.Your anxiety and depression score must be less than or equal to 10 on the HADS test.
Research Study Groups:
This trial has the following groups:- Group 1: Mind-body Intervention arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are fresh enrollees being accepted for this clinical trial?
"Unfortunately, clinicaltrials.gov reports that this particular trial is not currently recruiting patients, despite being initially posted on February 14th 2021 and its last update occurring in April 2022. Despite this setback, there are 48 other trials actively looking for participants at the moment."
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