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TIDHI Mental Health in IBD Patients Study

NCT07013578 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-08-11

No results posted yet for this study

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.

Conditions

  • Crohn Disease (CD)
  • Ulcerative Colitis (UC)
  • Inflammatory Bowel Disease (IBD)

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.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Celltrion

    collaborator INDUSTRY

  • TIDHI Innovation Inc.

    lead OTHER

Principal Investigators

  • Mark Silverberg, MD, PhD · TIDHI Innovation Inc.

  • Marci Reiss, DSW · TIDHI Innovation Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-22
Primary Completion
2026-12-31
Completion
2027-07-01

Countries

  • Canada

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07013578 on ClinicalTrials.gov