Clinical trial NCT07013578: TIDHI Mental Health in IBD Patients Study
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Crohn Disease (CD)
Ulcerative Colitis (UC)
Inflammatory Bowel Disease (IBD)
Keywords: Healing Circuits
Lead sponsor: TIDHI Innovation Inc.
Sponsor class: OTHER
Collaborators: name: Amgen
name: Celltrion
First posted: 2025-06-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score
timeFrame: 3 months following initiation of Healing Circuits™
measure: Time to Improvement in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score
timeFrame: 3 months following initiation of Healing Circuits™
measure: Change in Patient Health Questionnaire-9 (PHQ-9) Score
timeFrame: 3 months following initiation of Healing Circuits™
measure: Time to Improvement in Patient Health Questionnaire-9 (PHQ-9) Score
timeFrame: 3 months following initiation of Healing Circuits™
Secondary outcomes:
measure: Proportion of Participants Achieving at Least a 2-Point Reduction in GAD-7 Score
timeFrame: 6, 9, and 12 months following initiation of Healing Circuits™
measure: Proportion of Participants Achieving at Least a 2-Point Reduction in PHQ-9 Score
timeFrame: 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.
measure: Mean Change in 36-Item Short Form Survey (SF-36) Score Between Groups
timeFrame: 3, 6, 9, and 12 months following initiation of Healing Circuits™
measure: Mean Change in Patient Satisfaction Score on a Likert Scale Between Groups
timeFrame: 3, 6, 9, and 12 months following initiation of Healing Circuits™
Other outcomes:
Locations:
city: North York
country: Canada
facility: Toronto Immune and Digestive Health Institute
state: Ontario
Study officials:
affiliation: TIDHI Innovation Inc.
name: Mark Silverberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: TIDHI Innovation Inc.
name: Marci Reiss, DSW
role: PRINCIPAL_INVESTIGATOR
References: