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NCT06575660Completed

Digital Support for Mental Health Intervention in Patients With Inflammatory Bowel Disease

Source: ClinicalTrials.gov · Last updated 12 Nov 2025

Brief summary (registry, in English)

This is a small, exploratory study that will investigate using an artificial intelligence (AI) and virtual reality (VR), digital wellness application (app) to deliver a mental health support session in outpatient and hospitalized patients with inflammatory bowel disease (IBD) and co-existing symptoms of mild to moderate anxiety or depression. The purpose of this study is to explore if a mental health support session using the app is feasible, safe, and acceptable to IBD patients and whether it could possibly help with physical and comorbid psychological symptoms of these patients.

Status (registry)
Completed
Study type
Interventional
Enrollment
22 (actual)
First submitted
26 Aug 2024
Start date
23 Sept 2024
Primary completion date
9 Oct 2025
Lead sponsor
University of Chicago
NCT number
NCT06575660

What you commit to

  • Study type: Interventional
  • Participants enrolled: 22
  • From 23 Sept 2024 to the primary completion date, 9 Oct 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Self-reported history of severe motion sickness
  • Having had a seizure in the past year

Other

  • Unwilling and/or unable to participate
  • Non-English speakers
  • The presence of a facial/head deformity that will prohibit comfortably wearing of a VR headset
  • Legally blind or deaf
  • Unable to understand the instructions or to consent to participation in the study.
  • Those who are pregnant

Who the study is looking for

  • 18+ years of age
  • Patients with Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)
  • English-speaking
  • Patients with score of 5-14 on General Anxiety Disorder-7 (GAD-7) questionnaire or 5-19 on Patient Health Questionnaire-9 (PHQ-9) within 3 months
  • Able to provide written consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Chicago
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.