TIDHI Mental Health in IBD Patients Study

NCT ID
NCT07013578
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
TIDHI Innovation Inc.
Conditions
Crohn Disease (CD), Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC)

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: A Randomized Evaluation of Changes in Anxiety and Depression in Inflammatory Bowel Disease Patients Comparing Structured Mental Health Support to App Based Mental Health Support in Addition to Standard of Care Medical Treatment

Enrollment: 100 participants (Estimated).

What is being studied

  • Behavioral: Healing Circuits™ sessions
  • Behavioral: self-directed Healing Circuits™ curriculum

Who may be eligible

Ages
18 Years to 75 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: Subjects must meet each of the following criteria for enrolment into the study: 1. Written informed consent must be obtained and documented. 2. Males and females between the ages of 18 and 75 years of age with documented diagnosis of IBD. 3. GAD7 and/or PHQ9 score of 10 - 15. 4. Ability of subject to participate fully in all aspects of this clinical trial. 5. IBD patients who plan to have ongoing medical care at TIDHI. Exclusion Criteria: Subjects who exhibit any of the following conditions are to be excluded from the study: 1. Plan for change in systemically delivered IBD-related medical therapy in the 3 months after screening. 2. Serious underlying psychiatric disorder such as schizophrenia or bipolar disorder. 3. Planned change in psychiatric medication, if any is being taken, within 3 months after screening. 4. History of illegal drug abuse (excluding marijuana) or alcohol abuse which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: Canada

  • Ontario, Canada: 1

Sample of listed locations

  • Toronto Immune and Digestive Health Institute — North York, Ontario, M6A 3B4, Canada — Recruiting

Study details

Start date
July 22, 2025
Primary completion date
July 1, 2027
Completion date
December 31, 2027
First posted
June 10, 2025
Collaborators
Amgen, Celltrion

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07013578
Registry last updated
September 29, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT07013578 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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