TIDHI Mental Health in IBD Patients Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Healing Circuits™ sessions, self-directed Healing Circuits™ curriculum.
- Who it may be relevant to
- Registry conditions: Crohn Disease (CD), Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Behavioral 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. - Behavioral 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.
Primary outcome measures
- Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score [Time frame: 3 months following initiation of Healing Circuits™]
- Time to Improvement in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score [Time frame: 3 months following initiation of Healing Circuits™]
- Change in Patient Health Questionnaire-9 (PHQ-9) Score [Time frame: 3 months following initiation of Healing Circuits™]
- Time to Improvement in Patient Health Questionnaire-9 (PHQ-9) Score [Time frame: 3 months following initiation of Healing Circuits™]
Secondary outcome measures (4)
- 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™]
Eligibility criteria
Inclusion criteria
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.
Exclusion criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Toronto Immune and Digestive Health Institute — North York
Identifiers
NCT: NCT07013578 · 3665