VR Therapies for IBD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrennan Spiegel
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Distraction VR
- VR/AI CBT
Treatment groups
76 Participants
are divided into 2 treatment groupsSponsors and collaborators
Brennan Spiegel
Lead sponsor
Cedars-Sinai Medical Center
Sponsor institution
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Chicago
Collaborator
Source ClinicalTrials.gov