TIDHI Mental Health in IBD Patients Study

StatusRecruiting
PhaseNot applicable
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

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Trial flagged as At Risk
Primary completion moved at least 6 months later Dec 31, 2026 → Jul 1, 2027
See other at-risk trials from TIDHI Innovation Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 31, 2026 to Jul 1, 2027
    • Study completion pushed from Jul 1, 2027 to Dec 31, 2027
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 2 of 4 entries
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 28, 2025 to Jul 22, 2025
    • Site details revised
    v3
  3. Start date: Jun 15, 2025 to Jul 28, 2025
    • Eligibility criteria expanded, about 15 words
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07013578
Lead Sponsor TIDHI Innovation Inc.
Collaborators: Amgen, Celltrion
Conditions
(from sponsor)		 Crohn Disease (CD), Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD)
Related terms Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov