TIDHI Mental Health in IBD Patients Study

NCT07013578 | Recruiting

• 1 other identifier: 3665
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn Disease (CD); Ulcerative Colitis (UC); Inflammatory Bowel Disease (IBD)

Keywords

Healing Circuits

Outcome Measures

Primary Outcomes (4)

• Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score

  The Generalized Anxiety Disorder Assessment (GAD7) is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Scores range from 0 to 21, with higher scores indicating greater anxiety. This outcome will compare the mean change in GAD-7 scores from baseline between participants receiving one-on-one therapy and those receiving app-based therapy.

  3 months following initiation of Healing Circuits™

• Time to Improvement in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score

  Improvement is defined as a ≥2-point reduction from baseline in GAD-7 score. The outcome will compare the time (months ) it takes participants in the one-on-one therapy group and the app-based therapy group to reach this level of improvement.

  3 months following initiation of Healing Circuits™

• Change in Patient Health Questionnaire-9 (PHQ-9) Score

  PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. Scores range from 0 to 27, with higher scores indicating greater depression severity. This outcome will assess the mean difference in PHQ-9 scores between the one-on-one therapy and app-based therapy groups.

  3 months following initiation of Healing Circuits™

• Time to Improvement in Patient Health Questionnaire-9 (PHQ-9) Score

  Improvement is defined as a ≥2-point reduction from baseline in PHQ-9 score. This outcome compares the time (months ) it takes for participants in the one-on-one therapy group and the app-based therapy group to reach the improvement threshold.

  3 months following initiation of Healing Circuits™

Secondary Outcomes (4)

• Proportion of Participants Achieving at Least a 2-Point Reduction in GAD-7 Score

  6, 9, and 12 months following initiation of Healing Circuits™

• Proportion of Participants Achieving at Least a 2-Point Reduction in PHQ-9 Score

  This outcome measures the proportion of participants who experience a reduction of at least 2 points in the PHQ-9 (range: 0-27, higher scores = worse depression) at 6, 9, and 12 months after beginning the Healing Circuits™ intervention.

• Mean Change in 36-Item Short Form Survey (SF-36) Score Between Groups

  3, 6, 9, and 12 months following initiation of Healing Circuits™

• Mean Change in Patient Satisfaction Score on a Likert Scale Between Groups

  3, 6, 9, and 12 months following initiation of Healing Circuits™

Study Arms (2)

Sessions with a social worker based on Healing Circuits™ Methodology

EXPERIMENTAL

Behavioral: Healing Circuits™ sessions

Online modules of a self-directed Healing Circuits™ curriculum

EXPERIMENTAL

Behavioral: self-directed Healing Circuits™ curriculum

Interventions

Healing Circuits™ sessions BEHAVIORAL

Treatment of the Study group will involve 12-weekly 50-minute sessions with a social worker who has been trained in the Healing Circuits™ Methodology - a structured mental health support delivered by a therapist in a one-on-one model.

Sessions with a social worker based on Healing Circuits™ Methodology

self-directed Healing Circuits™ curriculum BEHAVIORAL

Treatment of the Control group will involve 12 weekly online modules of a self-directed Healing Circuits™ curriculum - structured mental health support being delivered in an web-based video instruction model.

Online modules of a self-directed Healing Circuits™ curriculum

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects who exhibit any of the following conditions are to be excluded from the study:
• Plan for change in systemically delivered IBD-related medical therapy in the 3 months after screening.
• Serious underlying psychiatric disorder such as schizophrenia or bipolar disorder.
• Planned change in psychiatric medication, if any is being taken, within 3 months after screening.
• 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

Sponsors & Collaborators

• TIDHI Innovation Inc.: lead
• Amgen: collaborator
• Celltrion: collaborator

Study Sites (1)

Toronto Immune and Digestive Health Institute

North York, Ontario, M6A 3B4, Canada

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Mark Silverberg, MD, PhD

  TIDHI Innovation Inc.

  PRINCIPAL INVESTIGATOR

• Marci Reiss, DSW

  TIDHI Innovation Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ajani Jeyakumar, HBSc BScN RN

CONTACT

647-812-2113; ajeyakumar@tidhi.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start: July 22, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

CA (1)