RecruitingRecruiting
TIDHI Mental Health in IBD Patients Study
NCT07013578 · TIDHI Innovation Inc.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
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 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
Study design
Enrollment target: 100 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-07-22
Estimated completion: 2027-07-01
Last updated: 2025-08-11
Interventions
Behavioral: Healing Circuits™ sessionsBehavioral: self-directed Healing Circuits™ curriculum
Primary outcomes
- • Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score (3 months following initiation of Healing Circuits™)
- • Time to Improvement in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score (3 months following initiation of Healing Circuits™)
- • Change in Patient Health Questionnaire-9 (PHQ-9) Score (3 months following initiation of Healing Circuits™)
Sponsor
TIDHI Innovation Inc. · other
With: Amgen, Celltrion
Contacts & investigators
ContactAjani Jeyakumar, HBSc BScN RN · contact · ajeyakumar@tidhi.ca · 647-812-2113
InvestigatorMark Silverberg, MD, PhD · principal_investigator, TIDHI Innovation Inc.
InvestigatorMarci Reiss, DSW · principal_investigator, TIDHI Innovation Inc.
All locations (1)
Toronto Immune and Digestive Health InstituteRecruiting
North York, Ontario, Canada