Inflammatory Bowel Disease (IBD)NCT07590518
VR Therapies for IBD
A study testing Distraction VR and VR/AI CBT in people with Inflammatory Bowel Disease (IBD) and Ulcerative Colitis (UC), run by Brennan Spiegel at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC), Crohn Disease (CD)
- What is being tested?
- Distraction VR and VR/AI CBT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Chicago
Chicago, Illinois, 60637
Alexandra McDermott, 847-409-0284, Alexandra.Mcdermott@bsd.uchicago.edu
David Rubin, MD
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Karisma K Suchak, MD, MSHS, 310-423-0714, karisma.suchak@cshs.org
Samuel Eberlein, MSHS, 310-423-6721, samuel.eberlein@cshs.org
About this study
Official title: AI-Enhanced Virtual Reality Cognitive Behavioral Therapy to Reduce Anxiety and Improve Quality of Life in Patients With Inflammatory Bowel Disease: A Multicenter Pilot and Feasibility 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.
Read the detailed description
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. distraction VR control among IBD patients with anxiety.
Participants will be randomized 1:1 to each study arm via the REDCap randomization module with allocation tables created by PASS. Block randomization will be used with random permuted block sizes of 6, 8, or 10, accounting for 20% additional subjects from the original sample size to allow for dropouts. The investigators will stratify randomization by sex to ensure balance in each arm. The investigators will also stratify randomization by current use of psychotropic or mental health medications/ prior psychotherapy to maintain balance.
Assessments will be performed at baseline and bi-weekly during the 8-week study period; this is a common treatment length for VR trials. While IBD is a chronic disease, the investigators must first assess the potential efficacy of the 8-week intervention in this pilot trial before evaluating durability in a definitive efficacy RCT.
- Being tested
- Distraction VR, VR/AI CBT
- Keywords
- Virtual Reality, Cognitive Behavioral Therapy
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distraction VRDevice
Distraction-based VR program with 2D nature videos to be used for 8-weeks for 10-20 minutes per week.
VR/AI CBTDevice
8-week protocolized VR/AI CBT program
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Distraction VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 8
Secondary outcomes (5)
Short Inflammatory Bowel Disease Questionnaire (SIBD-Q)
The SIBDQ is a 10-item, disease-targeted Health-Related Quality of Life (HRQoL) measure that evaluates 4 domains: bowel symptoms, systemic symptoms, emotional function, and social function. Each item is rated on a 7-point Likert scale, with total scores ranging from 10 to 70, higher scores indicate a better HRQoL and fewer IBD symptoms. The SIBDQ has been validated to detect meaningful changes in HRQoL in an outpatient setting.
The full version IBDQ, has been validated for its excellent internal consistency, test-retest reliability, and construct validity, distinguishing between active disease and remission, as well as convergent and divergent validity. The IBDQ is widely validated in clinical trials and real-world settings, making it a robust tool for assessing changes in HRQoL.
Measured: Baseline, Week 4, and Week 8
Patient Reported Outcome 2 (PRO2 for Ulcerative Colitis)
The PRO-2 is a simplified PRO measure used to assess Ulcerative Colitis (UC) activity. The PRO-2 focuses on rectal bleeding (ranging from 0-3; higher score indicates worse severity of bleeding) and average daily stool frequency. This tool provides a quick and reliable assessment of patient-reported disease activity. The PRO-2 has been validated against clinical markers of disease activity, such as endoscopic findings and biomarkers, and is sensitive to detecting changes in UC symptoms.Total PRO-2 scores range from 0 to 6, with higher scores indicating worse ulcerative colitis symptom severity.
Measured: Baseline, Week 4, and Week 8
Patient Reported Outcome 3 (PRO3 for Crohn's Disease)
The PRO-3 is a simplified PRO measures used to assess Crohn's Disease activity. The PRO-3 evaluates: abdominal pain (ranging from 0-3 with higher scores indicating worse abdominal pain), stool frequency (number of liquid or soft stools per day), and general well-being (5-point scale ranging from 0-4, higher score indicates worse general well-being). The PRO-3 has been validated against clinical markers of disease activity, such as endoscopic findings and biomarkers, and is sensitive to detecting changes in Crohn's Disease symptoms. Higher overall PRO-3 scores indicate worse Crohn's disease symptom severity.
Measured: Baseline, Week 4, and Week 8
29-item Patient Reported Outcomes Measurement System v2.1(PROMIS-29)
The PROMIS-29 is a validated 29-item questionnaire to assess general Health-Related Quality of Life (HRQoL) and treatment response in individuals with IBD. The assessment includes questions in each of the following domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity.
28 of the items use a 5-point Likert response scale that is T-scored, 1-5 with higher T-scores representing more of the domain measured (higher physical function/ability to participate in social roles and activities= better; higher anxiety/depression/fatigue/sleep disturbance/ pain interference=worse). Pain intensity uses a numeric rating scale, 0 to 10 with higher scores indicating greater pain intensity.
Measured: Baseline, Week 4, and Week 8
Visceral Sensitivity Index (VSI)
GI symptom-specific anxiety as measured by the VSI. The VSI is 15 items, rated on 6-point Likert scale ranging from 1 (strongly agree) to 6 (strongly disagree).
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brennan Spiegel
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Chicago
- Responsible party
- Sponsor-investigator, Brennan Spiegel, Cedars-Sinai Medical Center
- Investigators
- Brennan Spiegel, MD, MSHS, Principal investigator, Cedars-Sinai Medical CenterDavid Rubin, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590518
- Sponsor's protocol ID
- STUDY00004302
- Other IDs
- 1R01DK144719-01
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Enhanced Virtual Reality Cognitive Behavioral Therapy to Reduce Anxiety and Improve Quality of Life in Patients With Inflammatory Bowel Disease: A Multicenter Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT07590518
- Acronym / sponsor ID
- STUDY00004302
- Keywords
- Virtual Reality, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Brennan SpiegelUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Chicago
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. distraction VR control among IBD patients with anxiety.
Participants will be randomized 1:1 to each study arm via the REDCap randomization module with allocation tables created by PASS. Block randomization will be used with random permuted block sizes of 6, 8, or 10, accounting for 20% additional subjects from the original sample size to allow for dropouts. The investigators will stratify randomization by sex to ensure balance in each arm. The investigators will also stratify randomization by current use of psychotropic or mental health medications/ prior psychotherapy to maintain balance.
Assessments will be performed at baseline and bi-weekly during the 8-week study period; this is a common treatment length for VR trials. While IBD is a chronic disease, the investigators must first assess the potential efficacy of the 8-week intervention in this pilot trial before evaluating durability in a definitive efficacy RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR/AI CBT | Experimental | Device: VR/AI CBTThe 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. |
| Distraction VR | Sham comparator | Device: Distraction VRParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distraction VRDistraction-based VR program with 2D nature videos to be used for 8-weeks for 10-20 minutes per week. | Device | Distraction VR |
| VR/AI CBT8-week protocolized VR/AI CBT program | Device | VR/AI CBT |
Primary outcome
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 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)
Time frame: 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.
5 secondary outcomes
Short Inflammatory Bowel Disease Questionnaire (SIBD-Q)
Time frame: Baseline, Week 4, and Week 8
Patient Reported Outcome 2 (PRO2 for Ulcerative Colitis)
Time frame: Baseline, Week 4, and Week 8
Patient Reported Outcome 3 (PRO3 for Crohn's Disease)
Time frame: Baseline, Week 4, and Week 8
29-item Patient Reported Outcomes Measurement System v2.1(PROMIS-29)
Time frame: Baseline, Week 4, and Week 8
Visceral Sensitivity Index (VSI)
Time frame: Baseline, Week 4, and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brennan Spiegel, MD, MSHS principal investigator
Cedars-Sinai Medical Center
David Rubin, MD principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distraction VR and VR/AI CBT in people with Inflammatory Bowel Disease (IBD) and Ulcerative Colitis (UC), run by Brennan Spiegel at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karisma K Suchak, MD, MSHS (310-423-0714, karisma.suchak@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder-7 (GAD-7) (time frame: Bi-weekly; Baseline through Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.