NCT07013578Recruiting
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
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 2 Jun 2025
- Start date
- 22 Jul 2025
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- TIDHI Innovation Inc.
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07013578
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 22 Jul 2025 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Plan for change in systemically delivered IBD-related medical therapy in the 3 months after screening.
Other illness
- Subjects who exhibit any of the following conditions are to be excluded from the study:
- Serious underlying psychiatric disorder such as schizophrenia or bipolar disorder.
- Planned change in psychiatric medication, if any is being taken, within 3 months after screening.
- 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
Who the study is looking for
- Subjects must meet each of the following criteria for enrolment into the study:
- Written informed consent must be obtained and documented.
- Males and females between the ages of 18 and 75 years of age with documented diagnosis of IBD.
- GAD7 and/or PHQ9 score of 10 - 15.
- Ability of subject to participate fully in all aspects of this clinical trial.
- IBD patients who plan to have ongoing medical care at TIDHI.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Toronto Immune and Digestive Health Institute Coordinator of this site? Confirm its status | North YORK | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.