Inflammatory Bowel DiseasesNCT06910787
Outpatient VR (Virtual Reality)-Brain-gut Behavioral Therapies (BGBT) in Inflammatory Bowel Disease (IBD)
A study testing VR-directed BGBT and E-TAU in people with Inflammatory Bowel Diseases, run by University of Michigan at 1 site in United States.
Trial summary
This research study is being done to learn if a virtual reality (VR)-directed BGBT program is feasible and acceptable for patients to enhance pain treatment for patients with IBD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- VR-directed BGBT and E-TAU
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2025to Oct 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
- Adult outpatients (18 years and older) that carry a diagnosis of IBD and confirmed in the electronic health record (EHR) as receiving IBD-targeted treatment
- IBD-targeted treatment include 5-aminosalicylates, thiopurines, biologics, or small molecules such as Janus kinase inhibitor (JAK) inhibitors or sphingosine-1-receptor modulators.
- Self-report abdominal pain with an average severity ≥ 2 on a 0-10 pain scale over the last 24 hours,
- Participants are willing and able to pick-up and drop-off VR equipment at University of Michigan (UM)
Who cannot join
- Patients that do not report pain (i.e., score<2) as they are less likely to benefit from VR-directed BGBT
- Patients with a history of conditions that could potentially be harmed by VR including seizures/epilepsy, loss of awareness, binocular vision loss, current pregnancy, or uncontrolled cardiac (e.g., arrhythmia, coronary artery disease) or neurological/cerebrovascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outpatient Virtual Reality-Directed Treatment for Pain in Inflammatory Bowel Disease
This research study is being done to learn if a virtual reality (VR)-directed BGBT program is feasible and acceptable for patients to enhance pain treatment for patients with IBD.
The study hypothesis include:
- the study will achieve greater than 75% program completion and 75% study assessment completion
- patients with IBD will find VR-directed BGBT acceptable as an outpatient pain treatment
- outpatient VR-directed BGBT in IBD arm participants will report a greater reduction in pain scores, symptom burden, stress, depression, anxiety, and pain-related interference and an improvement in health-related quality of life
- will have lower opioid requirements and healthcare utilization at 4-weeks follow-up compared to the E-TAU arm
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- VR-directed BGBT, E-TAU
- Keywords
- Virtual Reality, Outpatient, Pain, Brain Gut Behavioral Treatment, Enhanced treatment as usual, Randomized
- Medical subject headings
- Inflammatory Bowel Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-directed BGBTDevice
VR-directed BGBT using the Oculus Meta Quest 3 VR headset will be delivered using the Synergi application. The program includes 4-weeks of daily self-led activities using 5 virtual modules: (1) education (2) two interactive games (3) breathing exercises (4) gut-directed meditation and (5) gastroenterology-specific Cognitive behavioral therapy (CBT). Participants will also receive standard care. On day 1, intervention arm participants will undergo a brief in-person or virtual (i.e., zoom or Microsoft teams) training with study staff to learn how to use the VR headset and access intervention modules. On day 1 participants will be asked to explore each of the program modules to achieve initial familiarity. Participants will be encouraged to use the VR-BGBT program for at least 15 minutes daily, but at minimum 3-4 days each week. Additionally, study assessments will be completed at baseline, 2-weeks, 4-weeks, and 8-weeks, with an interview within 1-2 weeks of completing the program.
E-TAUOther
Participants will receive standard of care, as directed by the participant's gastroenterologist. Participants will also receive an educational video and fact sheet on pain in IBD. This will be 4-weeks with study assessments at baseline, 2-weeks, and 4-weeks, 8-weeks.
| Study group | Role | What they receive |
|---|---|---|
| VR-directed BGBT | Experimental | Not described Receives: Device: VR-directed BGBT |
| Enhanced treatment as usual (E-TAU) | Active comparator | Not described Receives: Other: E-TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility defined by the proportion of enrolled participants that complete the 4-week VR-directed BGBT program and study assessments.
The study team hypothesizes the study will achieve greater than 75% program completion and 75% study assessment completion.
Measured: 4 weeks
Acceptability of VR-directed BGBT based on a semi-structured post intervention interview
The interview will be done to understand the participants' experience with the VR-directed BGBT intervention and conducted using interview guides with open-ended questions. interview guides will focus on four main domains related to participant's pain history, experience with VR-directed BGBT (including tolerability and acceptability of each BGBT module), perceived impact (including information on any components that were perceived to be most helpful or ineffective), and suggested improvements for program refinement.
Measured: 4 weeks
VR-BGBT acceptability using the Treatment Acceptability and Adherence Scale
This is a 10-question scale that participants choose from 1 (disagree strongly) - 7 (agree strongly). Scores range from 10-70 with higher scores indication greater acceptability.
Measured: 4 weeks
VR-BGBT usability using the System Usability Scale
This is a 10-question scale that participants choose from 1 (strongly agree) - 5 (strongly disagree). Scores range from 0 to 100 with a higher score indicating greater acceptability.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start29 Apr 2025
- Primary completion11 May 2026
- Study completionOct 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 DiseasesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to Enhanced Treatment as Usual (E-TAU) or VR-directed BGBT
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- American Gastroenterological Association
- Responsible party
- Principal investigator, Shirley Cohen-Mekelburg, University of Michigan
- Investigators
- Shirley Cohen-Mekelburg, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910787
- Sponsor's protocol ID
- HUM00267700
- Status last verified
- Jun 2026
- First submitted
- 28 Mar 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Virtual Reality-Directed Treatment for Pain in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06910787
- Acronym / sponsor ID
- HUM00267700
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Virtual Reality, Outpatient, Pain, Brain Gut Behavioral Treatment, Enhanced treatment as usual, Randomized
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- American Gastroenterological Association
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- Oct 2027 (estimated)
- First posted
- 4 Apr 2025 (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 research study is being done to learn if a virtual reality (VR)-directed BGBT program is feasible and acceptable for patients to enhance pain treatment for patients with IBD.
The study hypothesis include:
- the study will achieve greater than 75% program completion and 75% study assessment completion
- patients with IBD will find VR-directed BGBT acceptable as an outpatient pain treatment
- outpatient VR-directed BGBT in IBD arm participants will report a greater reduction in pain scores, symptom burden, stress, depression, anxiety, and pain-related interference and an improvement in health-related quality of life
- will have lower opioid requirements and healthcare utilization at 4-weeks follow-up compared to the E-TAU arm
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to Enhanced Treatment as Usual (E-TAU) or VR-directed BGBT
| Arm | Type | Receives |
|---|---|---|
| VR-directed BGBT | Experimental | Device: VR-directed BGBT |
| Enhanced treatment as usual (E-TAU) | Active comparator | Other: E-TAU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult outpatients (18 years and older) that carry a diagnosis of IBD and confirmed in the electronic health record (EHR) as receiving IBD-targeted treatment
- IBD-targeted treatment include 5-aminosalicylates, thiopurines, biologics, or small molecules such as Janus kinase inhibitor (JAK) inhibitors or sphingosine-1-receptor modulators.
- Self-report abdominal pain with an average severity ≥ 2 on a 0-10 pain scale over the last 24 hours,
- Participants are willing and able to pick-up and drop-off VR equipment at University of Michigan (UM)
Key exclusion criteria (2 listed)
- Patients that do not report pain (i.e., score<2) as they are less likely to benefit from VR-directed BGBT
- Patients with a history of conditions that could potentially be harmed by VR including seizures/epilepsy, loss of awareness, binocular vision loss, current pregnancy, or uncontrolled cardiac (e.g., arrhythmia, coronary artery disease) or neurological/cerebrovascular disease.
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 |
|---|---|---|
| VR-directed BGBTVR-directed BGBT using the Oculus Meta Quest 3 VR headset will be delivered using the Synergi application. The program includes 4-weeks of daily self-led activities using 5 virtual modules: (1) education (2) two interactive games (3) breathing exercises (4) gut-directed meditation and (5) gastroenterology-specific Cognitive behavioral therapy (CBT). Participants will also receive standard care. On day 1, intervention arm participants will undergo a brief in-person or virtual (i.e., zoom or Microsoft teams) training with study staff to learn how to use the VR headset and access intervention modules. On day 1 participants will be asked to explore each of the program modules to achieve initial familiarity. Participants will be encouraged to use the VR-BGBT program for at least 15 minutes daily, but at minimum 3-4 days each week. Additionally, study assessments will be completed at baseline, 2-weeks, 4-weeks, and 8-weeks, with an interview within 1-2 weeks of completing the program. | Device | VR-directed BGBT |
| E-TAUParticipants will receive standard of care, as directed by the participant's gastroenterologist. Participants will also receive an educational video and fact sheet on pain in IBD. This will be 4-weeks with study assessments at baseline, 2-weeks, and 4-weeks, 8-weeks. | Other | Enhanced treatment as usual (E-TAU) |
Primary outcome
Feasibility defined by the proportion of enrolled participants that complete the 4-week VR-directed BGBT program and study assessments.
Time frame: 4 weeks
The study team hypothesizes the study will achieve greater than 75% program completion and 75% study assessment completion.
Acceptability of VR-directed BGBT based on a semi-structured post intervention interview
Time frame: 4 weeks
The interview will be done to understand the participants' experience with the VR-directed BGBT intervention and conducted using interview guides with open-ended questions. interview guides will focus on four main domains related to participant's pain history, experience with VR-directed BGBT (including tolerability and acceptability of each BGBT module), perceived impact (including information on any components that were perceived to be most helpful or ineffective), and suggested improvements for program refinement.
VR-BGBT acceptability using the Treatment Acceptability and Adherence Scale
Time frame: 4 weeks
This is a 10-question scale that participants choose from 1 (disagree strongly) - 7 (agree strongly). Scores range from 10-70 with higher scores indication greater acceptability.
VR-BGBT usability using the System Usability Scale
Time frame: 4 weeks
This is a 10-question scale that participants choose from 1 (strongly agree) - 5 (strongly disagree). Scores range from 0 to 100 with a higher score indicating greater acceptability.
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 29 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Shirley Cohen-Mekelburg, MD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-directed BGBT and E-TAU in people with Inflammatory Bowel Diseases, run by University of Michigan 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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. 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?
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?
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?
Feasibility defined by the proportion of enrolled participants that complete the 4-week VR-directed BGBT program and study assessments. (time frame: 4 weeks). The study lists 4 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 29 Jun 2026.