Health Trials

TIDHI Mental Health in IBD Patients Study

ConditionsCrohn Disease (CD)Ulcerative Colitis (UC)Inflammatory Bowel Disease (IBD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTIDHI Innovation Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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 design

Treatments tested in this trial

  • Healing Circuits™ sessions
  • self-directed Healing Circuits™ curriculum

Treatment groups

100 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Toronto Immune and Digestive Health InstituteRecruitingM6A 3B4, North York, OntarioCanadaCanada

Sponsors and collaborators

TIDHI Innovation Inc.

Lead sponsor

Amgen

Collaborator

Celltrion

Collaborator

Source ClinicalTrials.gov