TIDHI Mental Health in IBD Patients Study

TIDHI Innovation Inc.

Status: Not yet enrolling

Conditions: Inflammatory Bowel Disease (IBD); Ulcerative Colitis (UC); Crohn Disease (CD)

Treatments: Behavioral: self-directed Healing Circuits™ curriculum; Behavioral: Healing Circuits™ sessions

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07013578

3665 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 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. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Sessions with a social worker based on Healing Circuits™ Methodology

Experimental group

Treatment:

Behavioral: Healing Circuits™ sessions

Online modules of a self-directed Healing Circuits™ curriculum

Experimental group

Treatment:

Behavioral: self-directed Healing Circuits™ curriculum