Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT07013578

TIDHI Mental Health in IBD Patients Study

Led by TIDHI Innovation Inc. · Updated on 2025-08-11

100

Participants Needed

1

Research Sites

101 weeks

Total Duration

On this page

Sponsors

T

TIDHI Innovation Inc.

Lead Sponsor

A

Amgen

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

TIDHI Mental Health in IBD Patients Study

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent
  • Male or female aged 18 to 75 years
  • Documented diagnosis of Inflammatory Bowel Disease (Crohn Disease or Ulcerative Colitis)
  • GAD-7 and/or PHQ-9 score between 10 and 15
  • Ability to participate fully in all aspects of the trial
  • Plan to receive ongoing medical care for IBD at TIDHI
Not Eligible

You will not qualify if you...

  • Planned change in systemic IBD therapy within 3 months after screening
  • Serious psychiatric disorder such as schizophrenia or bipolar disorder
  • Planned change in psychiatric medication within 3 months after screening
  • History of illegal drug abuse (excluding marijuana) or alcohol abuse that may interfere with study compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Toronto Immune and Digestive Health Institute

North York, Ontario, Canada, M6A 3B4

Actively Recruiting

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Research Team

A

Ajani Jeyakumar, HBSc BScN RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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TIDHI Mental Health in IBD Patients Study | DecenTrialz