TIDHI Mental Health in IBD Patients Study
Not applicable · Testing Healing Circuits™ sessions and self-directed Healing Circuits™ curriculum · 1 site · TIDHI Innovation Inc.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Healing Circuits™ sessions (a behavioral program) and self-directed Healing Circuits™ curriculum (a behavioral program) as a possible treatment. Condition(s) listed: Crohn Disease (CD), Ulcerative Colitis (UC) and Inflammatory Bowel Disease (IBD).
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 100 participants are expected to take part.
- The study has 2 groups.
- Start date: 2025-07-22.
- Main results expected around 2027-07-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Canada.
Groups in this study
- Sessions with a social worker based on Healing Circuits™ Methodology (listed as: experimental group)
- Online modules of a self-directed Healing Circuits™ curriculum (listed as: experimental group)
Main thing being measured
- Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score (3 months following initiation of Healing Circuits™)
- Time to Improvement in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score (3 months following initiation of Healing Circuits™)
- Change in Patient Health Questionnaire-9 (PHQ-9) Score (3 months following initiation of Healing Circuits™)
In the researchers’ words
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…
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease (CD); Ulcerative Colitis (UC); Inflammatory Bowel Disease (IBD) |
| Lead sponsor | TIDHI Innovation Inc. |
| Collaborators | Amgen; Celltrion |
| Enrollment | 100 (estimated) |
| Start date | 2025-07-22 |
| Primary completion (est.) | 2027-07-01 |
| First posted | 2025-06-10 |
| Last updated | 2026-09-29 |
| 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 |
| ClinicalTrials.gov ID | NCT07013578 |
Interventions
- Healing Circuits™ sessions (Behavioral)
Treatment of the Study group will involve 12-weekly 50-minute sessions with a social worker who has been trained in the Healing Circuits™ Methodology - a structured mental health support delivered by a therapist in a one-on-one model. - self-directed Healing Circuits™ curriculum (Behavioral)
Treatment of the Control group will involve 12 weekly online modules of a self-directed Healing Circuits™ curriculum - structured mental health support being delivered in an web-based video instruction model.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Toronto Immune and Digestive Health Institute | North York, Ontario | Canada | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.