RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-23
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06575660

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18+ years of age
  2. * Patients with Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)
  3. * English-speaking
  4. * 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
  5. * Able to provide written consent
  1. * Unwilling and/or unable to participate
  2. * Non-English speakers
  3. * Self-reported history of severe motion sickness
  4. * The presence of a facial/head deformity that will prohibit comfortably wearing of a VR headset
  5. * Legally blind or deaf
  6. * Having had a seizure in the past year
  7. * Unable to understand the instructions or to consent to participation in the study.
  8. * Those who are pregnant

Contacts and Locations

Study Contact

Research Coordinator
CONTACT
215-596-9715
Alex.Mathew@bsd.uchicago.edu

Principal Investigator

David T Rubin, MD
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

University of Chicago
Chicago, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • David T Rubin, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-23
Study Completion Date2025-09

Study Record Updates

Study Start Date2024-09-23
Study Completion Date2025-09

Terms related to this study

Additional Relevant MeSH Terms

  • Inflammatory Bowel Diseases
  • Anxiety
  • Depression
  • Ulcerative Colitis
  • Crohn Disease