Crohn Disease (CD)NCT07013578
TIDHI Mental Health in IBD Patients Study
A study testing Healing Circuits™ sessions and self-directed Healing Circuits™ curriculum in people with Crohn Disease (CD) and Ulcerative Colitis (UC), run by TIDHI Innovation Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease (CD), Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD)
- What is being tested?
- Healing Circuits™ sessions and self-directed Healing Circuits™ curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jul 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto Immune and Digestive Health Institute
North York, Ontario, M6A 3B4
Ajani Jeyakumar, 647-812-2113, ajeyakumar@tidhi.ca
About this 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
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.
- Being tested
- Healing Circuits™ sessions, self-directed Healing Circuits™ curriculum
- Keywords
- Healing Circuits
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Sessions with a social worker based on Healing Circuits™ Methodology | Experimental | Not described Receives: Behavioral: Healing Circuits™ sessions |
| Online modules of a self-directed Healing Circuits™ curriculum | Experimental | Not described Receives: Behavioral: self-directed Healing Circuits™ curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months following initiation of Healing Circuits™
Secondary outcomes (4)
Proportion of Participants Achieving at Least a 2-Point Reduction in GAD-7 Score
This outcome measures the proportion of participants who experience a reduction of at least 2 points in the GAD-7 (range: 0-21, higher scores = worse anxiety) at 6, 9, and 12 months after beginning the Healing Circuits™ intervention.
Measured: 6, 9, and 12 months following initiation of Healing Circuits™
Proportion of Participants Achieving at Least a 2-Point Reduction in PHQ-9 Score
6, 9, and 12 months following initiation of Healing Circuits™
Measured: 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
This outcome measures the mean difference in scores on the SF-36, a 36-item, patient-reported survey of patient health. Each item is scored out of 100 and a higher score is correlated to more favorable health. It addresses 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.
The comparison will be made between the one-on-one therapy group and the app-based therapy group at the specified time points.
Measured: 3, 6, 9, and 12 months following initiation of Healing Circuits™
Mean Change in Patient Satisfaction Score on a Likert Scale Between Groups
This outcome measures the mean difference in patient satisfaction between the one-on-one therapy group and the app-based therapy group. Satisfaction is assessed using a custom 10-point Likert scale ranging from 1 (Worst Possible Experience) to 10 (Best Possible Experience), with higher scores indicating greater satisfaction.
Measured: 3, 6, 9, and 12 months following initiation of Healing Circuits™
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start22 Jul 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TIDHI Innovation Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen, Celltrion
- Responsible party
- Sponsor
- Investigators
- Mark Silverberg, MD, PhD, Principal investigator, TIDHI Innovation Inc.Marci Reiss, DSW, Principal investigator, TIDHI Innovation Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013578
- Sponsor's protocol ID
- 3665
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07013578
- Acronym / sponsor ID
- 3665
- Keywords
- Healing Circuits
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- TIDHI Innovation Inc.University, hospital or other
- Collaborators
- Amgen, Celltrion
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healing Circuits™ sessionsTreatment 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. | Behavioural | Sessions with a social worker based on Healing Circuits™ Methodology |
| self-directed Healing Circuits™ curriculumTreatment 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. | Behavioural | Online modules of a self-directed Healing Circuits™ curriculum |
Primary outcome
Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score
Time frame: 3 months following initiation of Healing Circuits™
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.
Time to Improvement in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score
Time frame: 3 months following initiation of Healing Circuits™
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.
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: 3 months following initiation of Healing Circuits™
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.
Time to Improvement in Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: 3 months following initiation of Healing Circuits™
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.
4 secondary outcomes
Proportion of Participants Achieving at Least a 2-Point Reduction in GAD-7 Score
Time frame: 6, 9, and 12 months following initiation of Healing Circuits™
Proportion of Participants Achieving at Least a 2-Point Reduction in PHQ-9 Score
Time frame: 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
Time frame: 3, 6, 9, and 12 months following initiation of Healing Circuits™
Mean Change in Patient Satisfaction Score on a Likert Scale Between Groups
Time frame: 3, 6, 9, and 12 months following initiation of Healing Circuits™
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Silverberg, MD, PhD principal investigator
TIDHI Innovation Inc.
Marci Reiss, DSW principal investigator
TIDHI Innovation Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healing Circuits™ sessions and self-directed Healing Circuits™ curriculum in people with Crohn Disease (CD) and Ulcerative Colitis (UC), run by TIDHI Innovation Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ajani Jeyakumar, HBSc BScN RN (647-812-2113, ajeyakumar@tidhi.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score (time frame: 3 months following initiation of Healing Circuits™). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.