RecruitingNot ApplicableNCT07013578

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


Sponsor

TIDHI Innovation Inc.

Enrollment

100 participants

Start Date

Jul 22, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how to better support the mental health of people who have inflammatory bowel disease (IBD) — conditions like Crohn's disease or ulcerative colitis. Researchers want to understand and address anxiety and depression that often come alongside these gut conditions. **You may be eligible if...** - You are between 18 and 75 years old - You have a confirmed diagnosis of IBD (Crohn's disease or ulcerative colitis) - You are experiencing mild to moderate anxiety or depression (based on standard questionnaire scores) - You receive ongoing care at the TIDHI clinic **You may NOT be eligible if...** - Your IBD medication is expected to change in the next 3 months - You have a serious psychiatric condition such as schizophrenia or bipolar disorder - Your psychiatric medication is expected to change in the next 3 months - You have a history of significant alcohol or drug abuse (other than marijuana) that could interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALHealing Circuits™ sessions

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.

BEHAVIORALself-directed Healing Circuits™ curriculum

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.


Locations(1)

Toronto Immune and Digestive Health Institute

North York, Ontario, Canada

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NCT07013578


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