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Virtual reality meets AI: could a headset calm IBD anxiety?

NCT ID NCT07590518

Symptom relief Sponsor: Brennan Spiegel Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether an AI-enhanced virtual reality cognitive behavioral therapy (VR/AI CBT) program can reduce anxiety and improve quality of life in people with inflammatory bowel disease (IBD). Seventy-six adults with IBD and moderate-to-severe anxiety will be randomly assigned to either the VR/AI CBT program or a distraction VR program for 8 weeks. Researchers will measure changes in anxiety scores and how usable the VR system is.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AI-enhanced virtual reality cognitive behavioral therapy (VR/AI CBT) program
What this could lead to
If it works, this could offer a new, drug-free way to manage anxiety and improve daily life for people with inflammatory bowel disease.
What could go wrong
This is a small, early pilot study with only 76 participants, so results may not apply to everyone. The VR program is only available in English, which limits who can join.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 76 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anxiety Crohn disease (CD) Inflammatory bowel disease (IBD) Ulcerative colitis (UC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.