Crohn Disease (CD), Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC)
Conditions
Keywords
Healing Circuits
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.
Interventions
BEHAVIORALHealing 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.
BEHAVIORALself-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.
Sponsors
Amgen
Celltrion
TIDHI Innovation Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Improvement in Patient Health Questionnaire-9 (PHQ-9) Score | 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. |
| Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving at Least a 2-Point Reduction in GAD-7 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 GAD-7 (range: 0-21, higher scores = worse anxiety) at 6, 9, and 12 months after beginning the Healing Circuits™ intervention. |
| Proportion of Participants Achieving at Least a 2-Point Reduction in PHQ-9 Score | 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. | 6, 9, and 12 months following initiation of Healing Circuits™ |
| Mean Change in 36-Item Short Form Survey (SF-36) Score Between Groups | 3, 6, 9, and 12 months following initiation of Healing Circuits™ | 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. |
| Mean Change in Patient Satisfaction Score on a Likert Scale Between Groups | 3, 6, 9, and 12 months following initiation of Healing Circuits™ | 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. |
Countries
Canada
Contacts
Primary ContactAjani Jeyakumar, HBSc BScN RN
Outcome results
None listed