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VR Therapies for IBD

AI-Enhanced Virtual Reality Cognitive Behavioral Therapy to Reduce Anxiety and Improve Quality of Life in Patients With Inflammatory Bowel Disease: A Multicenter Pilot and Feasibility Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests virtual reality (VR) talk therapy that uses artificial intelligence (AI) against VR used for distraction. It is for adults with inflammatory bowel disease (IBD), which causes swelling in the gut, and anxiety. Researchers want to see if the therapy is practical to use and may ease anxiety and IBD symptoms.

Through a pilot randomized controlled trial (RCT), the aim is to test the clinical impact and feasibility of a AI-enhanced Virtual Reality (VR) Cognitive Behavioral therapy (CBT) program versus distraction VR among patients with inflammatory bowel disease (IBD) and anxiety. It is hypothesized that using VR/AI CBT may reduce anxiety and IBD symptoms, leading to improved overall physical, psychological, and social functioning when compared to distraction VR.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18 years or older.
  • Have a confirmed diagnosis of IBD and a score of 10 or higher on the GAD-7 anxiety survey.
  • Are willing to follow all study steps and the VR therapy plan, and can take part for the whole study.
  • Can read and write in English.
  • Have an internet-connected smartphone or computer, internet access, and email to complete study surveys.

Who can't join

  • Have a condition that makes VR unsafe or hard to use, such as past seizures, a face injury that prevents wearing the headset, or major trouble seeing or hearing.
  • Have problems with thinking or memory that would affect taking part.
  • Are currently in talk therapy. Taking anxiety medicine or having had talk therapy in the past does not rule you out.
  • Had IBD surgery in the past 6 months, or expect to have it in the next 6 months. This includes surgery around the anus.
  • Expect to change treatment for IBD inflammation during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Stated willingness to comply with all study procedures, VR therapy regimen, and availability for the duration of the study * Age of 18 years or older * Confirmed diagnosis of IBD with concurrent anxiety, defined as a GAD-7 score of ≥10 * Ability to read and write in English (VR/AI CBT program is currently only available in English) * Access to an internet-enabled device (android or iOS smartphone, or personal laptop or desktop computer) to complete surveys and has access to internet and email complete baseline and assessment surveys. Exclusion Criteria: * Have a condition that interferes with the safe use of VR usage, such as history of seizures, facial injuries precluding headset placement, significant visual or hearing impairment that impacts ability to see the VR images or follow audio instructions * Have cognitive impairments that would affect protocol participation. * Currently engaged in psychotherapy (Patients who are taking medications for anxiety or have previously engaged in psychotherapy but are not currently in therapy will remain eligible). * Have had an IBD related surgery (including perianal surgery) within the past 6 months or anticipated in the next 6 months * Anticipated to change their IBD inflammatory treatment during the study period.

Study sites (2)

CA

IL