Inflammatory Bowel DiseasesNCT06575660
Digital Support for Mental Health Intervention in Patients With Inflammatory Bowel Disease
A study testing Mental health support session in people with Inflammatory Bowel Diseases and Anxiety, run by University of Chicago at 1 site in United States.
Trial summary
This is a small, exploratory study that will investigate using an artificial intelligence (AI) and virtual reality (VR), digital wellness application (app) to deliver a mental health support session in outpatient and hospitalized patients with inflammatory bowel disease (IBD) and co-existing symptoms of mild to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Anxiety, Depression
- What is being tested?
- Mental health support session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2024to 9 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 18+ years of age
- Patients with Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)
- English-speaking
- Patients with score of 5-14 on General Anxiety Disorder-7 (GAD-7) questionnaire or 5-19 on Patient Health Questionnaire-9 (PHQ-9) within 3 months
- Able to provide written consent
Who cannot join
- Unwilling and/or unable to participate
- Non-English speakers
- Self-reported history of severe motion sickness
- The presence of a facial/head deformity that will prohibit comfortably wearing of a VR headset
- Legally blind or deaf
- Having had a seizure in the past year
- Unable to understand the instructions or to consent to participation in the study.
- Those who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
This is a small, exploratory study that will investigate using an artificial intelligence (AI) and virtual reality (VR), digital wellness application (app) to deliver a mental health support session in outpatient and hospitalized patients with inflammatory bowel disease (IBD) and co-existing symptoms of mild to moderate anxiety or depression.
The purpose of this study is to explore if a mental health support session using the app is feasible, safe, and acceptable to IBD patients and whether it could possibly help with physical and comorbid psychological symptoms of these patients.
Read the detailed description
The mental health support session is delivered by a virtual reality digital wellness application (app). The app is a Chat GPT-4 powered AI and VR platform called XAIA (eXtended reality Artificially Intelligent Ally). [Chat GPT is an AI program that generates dialogue.] The app is publicly available on the Apple Vision Pro (a VR tool). It was developed by a group of providers, including a psychiatrist, at Cedars-Sinai Medical Center to devise a scalable solution for the increasing demand for mental wellness experiences. The application uses the combination of an AI-powered virtual avatar, named "XAIA," and a VR environment to deliver immersive and personalized mental health support in mixed-reality environments.
This is a mixed method study with primarily a qualitative focus. Patients with IBD who self-report mild to moderate levels of anxiety or depression will be invited to try a single AI-VR mental health support session using the XAIA app. Participant observations, experiences, and opinions of the application will be collected through surveys and semi-structured interviews. Pre- and post- session pain and state anxiety scores will be collected.
- Being tested
- Mental health support session
- Medical subject headings
- Inflammatory Bowel Diseases, Anxiety Disorders, Depression, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental health support sessionBehavioural
a single AI-VR mental health support session using the XAIA application
| Study group | Role | What they receive |
|---|---|---|
| Patients with IBD who self-report mild to moderate levels of anxiety or depression | Experimental | Not described Receives: Behavioral: Mental health support session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the feasibility of utilizing a GPT-4-powered AI-VR mental health support session in patients with IBD
Measured via a post-session, semi-structured interview
Measured: Day 1 post-session
Determine the safety of utilizing a GPT-4-powered AI-VR mental health support session in patients with IBD
Measured by proportion of subjects with at least one adverse event
Measured: Day 1 post-session
Determine the patient acceptance of utilizing a GPT-4-powered AI-VR mental health support session in patients with IBD
Measured via Session Rating Scale (SRS V.3.0), which is a visual analogue scale that measures self-reported effective therapeutic relationships. Scores range from 0 to 40, with higher scores indicating more effective relationships. Scores are commonly classified as "any score lower than 36 overall, or 9 on any [of the 4] scale[s], could be a source of concern..."
Measured: Day 1 post-session
Secondary outcomes (4)
To assess change in pain scores pre- and post-session
Measured via Visual Analogue Pain Scale, which is a scale that measures self-reported pain intensity. Scores range from 0-10, with higher scores indicating greater pain intensity. Scores are commonly classified as "no pain" (0), "mild pain" (1-3), "moderate to severe pain" (4-6), "very severe pain" (7-9), "worst possible pain" (10).
Measured: Day 1 pre-session; Day 1 post-session
To assess change in mood scores pre- and post-session
Spielberger State-Trait Anxiety Inventory (STAI), which is a tool that measures self-reported anxiety. Scores range from 0-40, with higher scores indicating greater anxiety. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
Measured: Day 1 pre-session; Day 1 post-session
To characterize any limitations for creating a AI-VR mental health support tool optimally aligned with the needs of patients with IBD
Measured via a post-session, semi-structured interview
Measured: Day 1 post-session
To characterize any potential future improvements for creating a AI-VR mental health support tool optimally aligned with the needs of patients with IBD
Measured via a post-session, semi-structured interview
Measured: Day 1 post-session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start23 Sep 2024
- Primary completion9 Oct 2025
- Study completion9 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Cedars-Sinai Medical Center
- Responsible party
- Sponsor
- Investigators
- David T Rubin, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575660
- Sponsor's protocol ID
- IRB24-0605
- Status last verified
- Nov 2025
- First submitted
- 26 Aug 2024
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Support for Mental Health Intervention in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06575660
- Acronym / sponsor ID
- IRB24-0605
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Cedars-Sinai Medical Center
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 9 Oct 2025 (actual)
- Study completion
- 9 Oct 2025 (actual)
- First posted
- 28 Aug 2024 (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.
This is a small, exploratory study that will investigate using an artificial intelligence (AI) and virtual reality (VR), digital wellness application (app) to deliver a mental health support session in outpatient and hospitalized patients with inflammatory bowel disease (IBD) and co-existing symptoms of mild to moderate anxiety or depression.
The purpose of this study is to explore if a mental health support session using the app is feasible, safe, and acceptable to IBD patients and whether it could possibly help with physical and comorbid psychological symptoms of these patients.
Detailed description
The mental health support session is delivered by a virtual reality digital wellness application (app). The app is a Chat GPT-4 powered AI and VR platform called XAIA (eXtended reality Artificially Intelligent Ally). [Chat GPT is an AI program that generates dialogue.] The app is publicly available on the Apple Vision Pro (a VR tool). It was developed by a group of providers, including a psychiatrist, at Cedars-Sinai Medical Center to devise a scalable solution for the increasing demand for mental wellness experiences. The application uses the combination of an AI-powered virtual avatar, named "XAIA," and a VR environment to deliver immersive and personalized mental health support in mixed-reality environments.
This is a mixed method study with primarily a qualitative focus. Patients with IBD who self-report mild to moderate levels of anxiety or depression will be invited to try a single AI-VR mental health support session using the XAIA app. Participant observations, experiences, and opinions of the application will be collected through surveys and semi-structured interviews. Pre- and post- session pain and state anxiety scores will be collected.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with IBD who self-report mild to moderate levels of anxiety or depression | Experimental | Behavioral: Mental health support session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18+ years of age
- Patients with Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)
- English-speaking
- Patients with score of 5-14 on General Anxiety Disorder-7 (GAD-7) questionnaire or 5-19 on Patient Health Questionnaire-9 (PHQ-9) within 3 months
- Able to provide written consent
Key exclusion criteria (8 listed)
- Unwilling and/or unable to participate
- Non-English speakers
- Self-reported history of severe motion sickness
- The presence of a facial/head deformity that will prohibit comfortably wearing of a VR headset
- Legally blind or deaf
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 |
|---|---|---|
| Mental health support sessiona single AI-VR mental health support session using the XAIA application | Behavioural | Patients with IBD who self-report mild to moderate levels of anxiety or depression |
Primary outcome
Determine the feasibility of utilizing a GPT-4-powered AI-VR mental health support session in patients with IBD
Time frame: Day 1 post-session
Measured via a post-session, semi-structured interview
Determine the safety of utilizing a GPT-4-powered AI-VR mental health support session in patients with IBD
Time frame: Day 1 post-session
Measured by proportion of subjects with at least one adverse event
Determine the patient acceptance of utilizing a GPT-4-powered AI-VR mental health support session in patients with IBD
Time frame: Day 1 post-session
Measured via Session Rating Scale (SRS V.3.0), which is a visual analogue scale that measures self-reported effective therapeutic relationships. Scores range from 0 to 40, with higher scores indicating more effective relationships. Scores are commonly classified as "any score lower than 36 overall, or 9 on any [of the 4] scale[s], could be a source of concern..."
4 secondary outcomes
To assess change in pain scores pre- and post-session
Time frame: Day 1 pre-session; Day 1 post-session
To assess change in mood scores pre- and post-session
Time frame: Day 1 pre-session; Day 1 post-session
To characterize any limitations for creating a AI-VR mental health support tool optimally aligned with the needs of patients with IBD
Time frame: Day 1 post-session
To characterize any potential future improvements for creating a AI-VR mental health support tool optimally aligned with the needs of patients with IBD
Time frame: Day 1 post-session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
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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. This study is not recruiting at the moment.
David T Rubin, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental health support session in people with Inflammatory Bowel Diseases and Anxiety, run by University of Chicago at 1 site 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 8 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: finished, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the feasibility of utilizing a GPT-4-powered AI-VR mental health support session in patients with IBD (time frame: Day 1 post-session). The study lists 3 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 12 Nov 2025.