VR Therapies for IBD

NCT07590518 | Not Yet Recruiting FDA Device

• 2 other identifiers: STUDY000043021R01DK144719-01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Inflammatory Bowel Disease (IBD); Ulcerative Colitis (UC); Crohn Disease (CD); Anxiety

Keywords

Virtual Reality; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (2)

• Generalized Anxiety Disorder-7 (GAD-7)

  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.

  Bi-weekly; Baseline through Week 8

• System Usability Scale (SUS)

  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.

  Week 8

Secondary Outcomes (5)

• Short Inflammatory Bowel Disease Questionnaire (SIBD-Q)

  Baseline, Week 4, and Week 8

• Patient Reported Outcome 2 (PRO2 for Ulcerative Colitis)

  Baseline, Week 4, and Week 8

• Patient Reported Outcome 3 (PRO3 for Crohn's Disease)

  Baseline, Week 4, and Week 8

• 29-item Patient Reported Outcomes Measurement System v2.1(PROMIS-29)

  Baseline, Week 4, and Week 8

• Visceral Sensitivity Index (VSI)

  Baseline, Week 4, and Week 8

Other Outcomes (2)

• Serum C-Reactive Protein (CRP)

  Baseline and Week 8

• Fecal Calprotectin (fCal)

  Baseline and Week 8

Study Arms (2)

VR/AI CBT

EXPERIMENTAL

The VR/AI CBT program will be delivered through the Meta Quest 2 device and is self-administered and includes a network of environments arranged in a virtual clinic that participants experience at home though a protocolized, 8-week program. Depending on the module, experiences within the program last between 10-20 minutes. Participants will be prompted to regularly use the headset each week over the 8-week study period. The VR modules are reinforced with regularly scheduled messages and CBT exercises delivered by a webapp that is available on any smartphone or computer. The program progressively builds new skills and culminates in transitioning from using VR to applying the skills learned in VR to everyday life.

Device: VR/AI CBT

Distraction VR

SHAM COMPARATOR

Participants in the distraction VR group will receive the same Meta Quest 2 device but will only have access to a distraction-based VR therapy program that includes 2D nature videos (e.g., relaxing on a beach, swimming with dolphins). Similar to the VR/AI CBT arm, people in the distraction VR group will be prompted to regularly use the headset each week for the 8-week treatment period.

Device: Distraction VR

Interventions

Distraction VR DEVICE

Distraction-based VR program with 2D nature videos to be used for 8-weeks for 10-20 minutes per week.

Distraction VR

VR/AI CBT DEVICE

8-week protocolized VR/AI CBT program

VR/AI CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brennan Spiegel: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Chicago: collaborator

Study Sites (2)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease; Anxiety Disorders

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Mental Disorders

Study Officials

• Brennan Spiegel, MD, MSHS

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• David Rubin, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karisma K Suchak, MD, MSHS

CONTACT

310-423-0714; karisma.suchak@cshs.org

Samuel Eberlein, MSHS

CONTACT

310-423-6721; samuel.eberlein@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Health Services Research; Professor of Medicine

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 15, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

US (2)