NCT07013578 TIDHI Mental Health in IBD Patients Study
| NCT ID | NCT07013578 |
| Status | Recruiting |
| Phase | — |
| Sponsor | TIDHI Innovation Inc. |
| Condition | Crohn Disease (CD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-07-22 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-07-22 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Mark Silverberg, MD, PhD
PRINCIPAL INVESTIGATOR
TIDHI Innovation Inc.
Frequently Asked Questions
Who can join the NCT07013578 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Crohn Disease (CD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07013578 currently recruiting?
Yes, NCT07013578 is actively recruiting participants. Contact the research team at ajeyakumar@tidhi.ca for enrollment information.
Where is the NCT07013578 trial being conducted?
This trial is being conducted at North York, Canada.
Who is sponsoring the NCT07013578 clinical trial?
NCT07013578 is sponsored by TIDHI Innovation Inc.. The principal investigator is Mark Silverberg, MD, PhD at TIDHI Innovation Inc.. The trial plans to enroll 100 participants.