Recruiting

Healing Circuits™

Sponsor:

TIDHI Innovation Inc.

Code:

NCT07013578

Conditions

Crohn Disease (CD)

Ulcerative Colitis (UC)

Inflammatory Bowel Disease (IBD)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Healing Circuits™ sessions

self-directed Healing Circuits™ curriculum

Study Details

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)

Study ID

NCT07013578

Start date

Jul 22, 2025

Status verified date

Aug, 2025

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sessions with a social worker based on Healing Circuits™ Methodology

experimental: Online modules of a self-directed Healing Circuits™ curriculum

Interventions

Healing Circuits™ sessions

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.

self-directed Healing Circuits™ curriculum

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.

Primary outcome measure

  • Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score [ Time Frame: 3 months following initiation of Healing Circuits™ ]
  • Time to Improvement in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score [ Time Frame: 3 months following initiation of Healing Circuits™ ]
  • Change in Patient Health Questionnaire-9 (PHQ-9) Score [ Time Frame: 3 months following initiation of Healing Circuits™ ]
  • Time to Improvement in Patient Health Questionnaire-9 (PHQ-9) Score [ Time Frame: 3 months following initiation of Healing Circuits™ ]

Central Contacts and Locations

Central contacts

Ajani Jeyakumar, HBSc BScN RN

647-812-2113ajeyakumar@tidhi.ca

Locations

Toronto Immune and Digestive Health Institute

Recruiting

North York, Ontario, Canada, M6A 3B4

Contacts

Ajani Jeyakumar

647-812-2113ajeyakumar@tidhi.ca

More Information

Sponsor

TIDHI Innovation Inc.

Last update posted

Aug 11, 2025

Last verified

Aug, 2025

Keywords

  • Healing Circuits

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by TIDHI Innovation Inc. on 2025-08-11.