TIDHI Healing Circuits mental health program for people with IBD

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

This study tests whether Healing Circuits™ delivered by a social worker or via a self-guided online program helps adults with IBD who have moderate anxiety or depression.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: TIDHI Innovation Inc. (Academic / other)
• Locations: 1 site (North York, Ontario)
• Trial ID: NCT07013578 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with a documented IBD diagnosis, GAD-7 or PHQ-9 scores of 10–15, ability to participate fully in study activities, and plans for ongoing care at TIDHI are ideal candidates.

Not a fit: People with serious psychiatric disorders (e.g., schizophrenia or bipolar), planned changes in systemic IBD or psychiatric medications within three months, or active substance/alcohol abuse are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the program could reduce anxiety and depressive symptoms and improve quality of life for adults with IBD.

How similar studies have performed: Psychological support and digital mental-health programs in IBD have shown modest benefits in prior research, but Healing Circuits™ as a branded program appears novel with limited published evidence.

Eligibility criteria

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 this trial is running

North York, Ontario

• 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

Conditions Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Disease; Healing Circuits