TIDHI Mental Health in IBD Patients Study
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
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.
Canadian Sites (1)
Toronto Immune and Digestive Health Institute
North York, Ontario, Canada
Eligibility Criteria
See who this study is looking for11 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +GAD7 and/or PHQ9 score of 10 - 15.
- +Subjects must meet each of the following criteria for enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → into the study:
- +Written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → must be obtained and documented.
- +Males and females between the ages of 18 and 75 years of age with documented diagnosis of IBD.
- +Ability of subject to participate fully in all aspects of this clinical trialInterventional studyA study where participants are given something to see what happens.Read more →.
- +IBD patients who plan to have ongoing medical care at TIDHI.
Exclusion
- −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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → may interfere with the subject's ability to comply with the study procedures
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: Healing Circuits™ sessions, self-directed Healing Circuits™ curriculum.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 18 years to 75 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 100 people.
The study is currently expected to finish around July 2027.
The main measurement is taken over: 3 months following initiation of Healing Circuits™.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score — measured over 3 months following initiation of Healing Circuits™.
Time to Improvement in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score — measured over 3 months following initiation of Healing Circuits™.
Change in Patient Health Questionnaire-9 (PHQ-9) Score — measured over 3 months following initiation of Healing Circuits™.
Time to Improvement in Patient Health Questionnaire-9 (PHQ-9) Score — measured over 3 months following initiation of Healing Circuits™.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07013578 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Healing Circuits™ sessionsBehavioural
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.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
About self-directed Healing Circuits™ curriculumBehavioural
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.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 75 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 75 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 3 months following initiation of Healing Circuits™.
The study as a whole is currently expected to finish around 2027-07-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 100 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: North York, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.