Digital Support for Mental Health Intervention in Patients With Inflammatory Bowel Disease
Launched by UNIVERSITY OF CHICAGO · Aug 27, 2024
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new way to support the mental health of patients with inflammatory bowel disease (IBD), such as Crohn's disease or ulcerative colitis, who are also experiencing mild to moderate anxiety or depression. The study will use a digital wellness app that combines artificial intelligence and virtual reality to provide mental health support sessions. Researchers want to find out if this approach is safe, acceptable, and helpful for patients dealing with both physical and emotional symptoms related to their condition.
To participate in the study, individuals must be 18 years or older, speak English, and have been diagnosed with IBD. They should also have scores indicating mild to moderate anxiety or depression based on specific questionnaires. Participants will be recruited from both outpatient settings and hospitals. If you choose to take part, you can expect to engage with the app during mental health sessions designed to improve your overall well-being. It's important to note that there are certain criteria that would exclude someone from participating, such as severe motion sickness or certain medical conditions.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
- Exclusion Criteria:
- • Unwilling and/or unable to participate
- • Non-English speakers
- • Self-reported history of severe motion sickness
- • The presence of a facial/head deformity that will prohibit comfortably wearing of a VR headset
- • Legally blind or deaf
- • Having had a seizure in the past year
- • Unable to understand the instructions or to consent to participation in the study.
- • Those who are pregnant
About University Of Chicago
The University of Chicago is a prestigious research institution renowned for its commitment to advancing medical science through innovative clinical trials. With a robust infrastructure that supports multidisciplinary collaboration, the University actively engages in cutting-edge research across various therapeutic areas. Its dedicated team of experienced investigators and state-of-the-art facilities enable the University of Chicago to conduct rigorous clinical studies aimed at improving patient outcomes and translating scientific discoveries into tangible healthcare solutions. The institution prioritizes ethical standards and patient safety, ensuring that all trials adhere to the highest regulatory guidelines and best practices in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Patients applied
Trial Officials
David T Rubin, MD
Principal Investigator
University of Chicago
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported