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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
| Celltrion | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sessions with a social worker based on Healing Circuits™ Methodology | Experimental |
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| Online modules of a self-directed Healing Circuits™ curriculum | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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™ |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6, 9, and 12 months following initiation of Healing Circuits™ |
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Inclusion Criteria:
Subjects must meet each of the following criteria for enrolment into the study:
Exclusion Criteria:
Subjects who exhibit any of the following conditions are to be excluded from the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ajani Jeyakumar, HBSc BScN RN | Contact | 647-812-2113 | ajeyakumar@tidhi.ca |
| Name | Affiliation | Role |
|---|---|---|
| Mark Silverberg, MD, PhD | TIDHI Innovation Inc. | Principal Investigator |
| Marci Reiss, DSW | TIDHI Innovation Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Immune and Digestive Health Institute | Recruiting | North York | Ontario | M6A 3B4 | Canada |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| 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. |
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| Proportion of Participants Achieving at Least a 2-Point Reduction in PHQ-9 Score | 6, 9, and 12 months following initiation of Healing Circuits™ | 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. | 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. | 3, 6, 9, and 12 months following initiation of Healing Circuits™ |
| D003092 | Colitis |
| D003108 | Colonic Diseases |