NCT07013578

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: TIDHI Innovation Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn Disease (CD)
• Ulcerative Colitis (UC)
• Inflammatory Bowel Disease (IBD)

Interventions

Type	Name	Description
BEHAVIORAL	Healing 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.
BEHAVIORAL	self-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.

Timeline

• Start date: 2025-07-22
• Primary completion: 2026-12-31
• Completion: 2027-07-01
• First posted: 2025-06-10
• Last updated: 2025-08-11

Locations

1 site across 1 country: Canada