VR Therapies for IBD
Sponsored by Brennan Spiegel
About this study
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.
In this pilot randomized controlled trial (RCT), the investigators aim to test the feasibility and preliminary clinical impact of a novel virtual reality (VR) cognitive behavioral therapy (CBT) program supported by artificial intelligence (AI) vs. distraction VR control among patients with IBD and anxiety. The investigators will conduct this pilot RCT with 76 participants with with IBD and anxiety to achieve the following aims: Aim 1-Establish the feasibility of using an 8-week VR/AI CBT program among patients with IBD and anxiety; Aim 2-Acquire preliminary data assessing the clinical impact of an 8-week VR/AI CBT program vs. distraction VR control among patients with IBD with anxiety.; Aim 3-Acquire exploratory data assessing the biomarker impact of an 8-week VR/AI CBT program vs. distra…
Where this study is enrolling (2)
- I'm interested
Cedars-Sinai Medical Center
Los Angeles, California
- I'm interested
University of Chicago
Chicago, Illinois
Who can participate
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.
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.