ClinConnect ClinConnect Logo
Search / Trial NCT07013578

TIDHI Mental Health in IBD Patients Study

Launched by TIDHI INNOVATION INC. · Jun 9, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Healing Circuits

ClinConnect Summary

The TIDHI Mental Health in IBD Patients Study is looking to understand how a specific mental health support program called Healing Circuits™ can help individuals with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. In this study, participants will be randomly placed into two groups: one group will receive personal support from a social worker, while the other group will follow a self-directed online program using video instructions. Both groups will be evaluated over 12 months to see how well this support helps with their mental health.

To participate, individuals must be between 18 and 75 years old and have a confirmed diagnosis of IBD. They should also have mild to moderate symptoms of anxiety or depression, as indicated by specific screening tools. It's important to note that people with serious psychiatric disorders or a recent history of substance abuse may not be eligible. Those who join the study can expect to receive valuable mental health support tailored to their needs, whether in-person or online, while continuing their regular medical care for IBD.

Gender

ALL

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 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. 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

About Tidhi Innovation Inc.

Tidhi Innovation Inc. is a forward-thinking clinical trial sponsor dedicated to advancing healthcare through innovative research and development. With a focus on enhancing patient outcomes, Tidhi leverages cutting-edge technology and a collaborative approach to design and execute clinical trials across various therapeutic areas. Committed to regulatory compliance and ethical standards, the company aims to foster partnerships with healthcare professionals and institutions to ensure rigorous data integrity and patient safety. Through its strategic initiatives, Tidhi Innovation Inc. strives to bring novel therapies to market, ultimately improving the quality of life for patients worldwide.

Locations

North York, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Mark Silverberg, MD, PhD

Principal Investigator

TIDHI Innovation Inc.

Marci Reiss, DSW

Principal Investigator

TIDHI Innovation Inc.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported