TIDHI Healing Circuits mental health program for people with IBD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with Crohn disease or ulcerative colitis and moderate symptoms on the GAD-7 or PHQ-9 will be randomly assigned to one of two delivery methods of the same structured mental health program, Healing Circuits™: sessions with a social worker or a self-directed online curriculum. Both groups receive the same content and are followed for 12 months to compare outcomes. The protocol requires stable IBD and psychiatric medication plans around the time of enrollment and ongoing care at the TIDHI center. Mental health symptom scores and participation metrics will be tracked over the study period.

Why it matters

Who can join: the full rules

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

Where it's running

• Toronto Immune and Digestive Health Institute
  North York, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Mark Silverberg, MD, PhD — TIDHI Innovation Inc.
• Study coordinator: Ajani Jeyakumar, HBSc BScN RN
• Email: ajeyakumar@tidhi.ca
• Phone: 647-812-2113

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.