Digital Support for Mental Health Intervention in Patients With Inflammatory Bowel Disease (NCT06575660) | Clinical Trial Compass
CompletedNot Applicable
Digital Support for Mental Health Intervention in Patients With Inflammatory Bowel Disease
United States22 participantsStarted 2024-09-23
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine the feasibility of utilizing a GPT-4-powered AI-VR mental health support session in patients with IBD
Timeframe: Day 1 post-session
2
Determine the safety of utilizing a GPT-4-powered AI-VR mental health support session in patients with IBD
Timeframe: Day 1 post-session
3
Determine the patient acceptance of utilizing a GPT-4-powered AI-VR mental health support session in patients with IBD