VR Therapies for IBD and Anxiety

This study is exploring two types of virtual reality (VR) programs for people with Inflammatory Bowel Disease (IBD), such as Ulcerative Colitis (UC) or Crohn Disease (CD), who also experience anxiety. One program uses VR to provide distraction with nature videos, while the other is an 8-week VR/AI CBT (Cognitive Behavioral Therapy) program that uses artificial intelligence. The goal is to see if the VR/AI CBT program can help reduce anxiety and IBD symptoms more effectively than the distraction VR. You might be able to join if you are 18 or older, have a confirmed IBD diagnosis with anxiety (a GAD-7 score of 10 or higher), can read and write English, and have internet access. The study aims to enroll 76 participants. The current status of the study is unclear.

Study design
This is a pilot randomized controlled trial, meaning participants will be randomly assigned to one of two groups. The study plans to include 76 participants.
What's involved
You would use a VR program for 8 weeks. The distraction VR program involves 10-20 minutes per week, but the time commitment for the VR/AI CBT program is not specified.
Compensation
Not stated in the trial record.
Follow-up
Your anxiety levels (GAD-7) will be measured bi-weekly from the start through Week 8. System Usability Scale (SUS) will be measured at Week 8.

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NCT07590518

VR Therapies for IBD

Not Yet Recruiting
NAAges 18+InterventionalTreatment
Brennan Spiegel
~76 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:Distraction VRVR/AI CBT

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Generalized Anxiety Disorder-7 (GAD-7)
Measured over Bi-weekly; Baseline through Week 8
+1 more outcome measured
Inflammatory Bowel Disease (IBD)
Ulcerative Colitis (UC)
Crohn Disease (CD)
Anxiety
2 sites across 2 states
California1
Illinois1
  • Brennan Spiegel, MD, MSHS · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center
  • David Rubin, MD · PRINCIPAL_INVESTIGATOR · University of Chicago

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Eligibility criteria

Inclusion

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

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.
  • Generalized Anxiety Disorder-7 (GAD-7)Bi-weekly; Baseline through Week 8

    The GAD-7 is a 7-item scale for screening and assessing the severity of generalized anxiety disorder. It has a 2-week recall period and is scored on a 0-21 scale-0-4: minimal anxiety; 5-9: mild; 10-14: moderate; 15-21 severe. It has high reliability and criterion validity across many clinical contexts. The minimal clinically important difference (MCID) is 4 points.

  • System Usability Scale (SUS)Week 8

    The SUS is a validated, widely-used ten-item Likert scale giving a global view of assessments of usability, with each item rated on a scale of 0 to 5. Higher scores indicate greater usability.