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
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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⁃ Subjects must meet each of the following criteria for enrolment into the study:

• Written informed consent must be obtained and documented.

• Males and females between the ages of 18 and 75 years of age with documented diagnosis of IBD.

• GAD7 and/or PHQ9 score of 10 - 15.

• Ability of subject to participate fully in all aspects of this clinical trial.

• IBD patients who plan to have ongoing medical care at TIDHI.

Locations
Other Locations
Canada
Toronto Immune and Digestive Health Institute
RECRUITING
North York
Contact Information
Primary
Ajani Jeyakumar, HBSc BScN RN
ajeyakumar@tidhi.ca
647-812-2113
Time Frame
Start Date: 2025-07-22
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 100
Treatments
Experimental: Sessions with a social worker based on Healing Circuits™ Methodology
Experimental: Online modules of a self-directed Healing Circuits™ curriculum
Sponsors
Collaborators: Amgen, Celltrion
Leads: TIDHI Innovation Inc.

This content was sourced from clinicaltrials.gov