TIDHI Mental Health in IBD Patients Study
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
- Crohn Disease (CD)
- Ulcerative Colitis (UC)
- Inflammatory Bowel Disease (IBD)
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- TIDHI Innovation Inc.
- Enrolment target
- 100
- Started
- 22 July 2025
- Main results due
- 1 July 2027
- Study sites
- 1
- Registry updated
- 29 September 2026
Can you take part?
- Ages 18 years to 75 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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
What this study is about
In the sponsor’s own words, from the registry.
The purpose of this study is to test the impact of Healing Circuits™; a structured mental health support model on IBD patients. The eligible study participants will be randomly divided into two groups: 1. the group receiving structured mental health support with a social worker and 2. the group receiving structured mental health support via a self-directed online curriculum. Both groups will be receiving the same type of therapy, Healing Circuits™, but the group receiving the therapy via the online self-directed curriculum will be receiving the therapy mostly by web-based video instruction. The two groups will be evaluated over a period of 12 months.
Study sites(1)
Toronto Immune and Digestive Health Institute
North York, Ontario, Canada
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07013578. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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