Digital mental health support for patients with inflammatory bowel disease
Digital Support for Mental Health Intervention in Patients With Inflammatory Bowel Disease
This study is testing a new app that uses virtual reality and AI to see if it can help people with inflammatory bowel disease who are feeling anxious or depressed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06575660 on ClinicalTrials.gov |
What this trial studies
This exploratory study investigates the feasibility and acceptability of a digital wellness application that combines artificial intelligence and virtual reality to provide mental health support for patients with inflammatory bowel disease (IBD) experiencing mild to moderate anxiety or depression. The application, called XAIA, delivers personalized mental health sessions in a mixed-reality environment. Participants will engage in a single session, and their experiences will be assessed through surveys and interviews, alongside pre- and post-session evaluations of pain and anxiety levels.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 18 and older with a diagnosis of inflammatory bowel disease and mild to moderate anxiety or depression.
Not a fit: Patients with severe motion sickness, significant sensory impairments, or those unable to engage with the VR technology may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance mental health support for IBD patients, potentially improving their overall well-being and quality of life.
How similar studies have performed: While the use of AI and VR for mental health support is an emerging field, this specific approach is novel and has not been extensively tested in similar populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- University of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: David T Rubin, MD — University of Chicago
- Study coordinator: Research Coordinator
- Email: Alex.Mathew@bsd.uchicago.edu
- Phone: 215-596-9715
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.