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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK140676 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Through a pilot randomized controlled trial (RCT), the aim is to test the clinical impact and feasibility of a virtual reality (VR) cognitive behavioral therapy (CBT) program versus sham VR among patients with irritable bowel syndrome (IBS). It is hypothesized that using VR-administered CBT may reduce abdominal pain, leading to improved overall physical, psychological, and social functioning when compared to sham VR.
A pilot randomized, sham-controlled clinical trial will be conducted in participants with IBS to achieve the following aims: Aim 1-collect preliminary data assessing the clinical impact of VR cognitive behavioral therapy (CBT) (SynerGI); Aim 2-establish the feasibility of using an 8-week VR CBT program among patients with IBS. The study will follow the established NIH protocol for conducting VR clinical trials, which aligns with VR-CORE clinical trial guidance. Participants will be randomized in a 1:1 ratio between two arms : (i) immersive VR CBT Program (SynerGI); and (ii) sham VR. As a pilot randomized controlled trial, it will not be powered for hypothesis testing of clinical outcomes . Instead, the focus will be on determining the plausibility and feasibility of SynerGI, with the aim to recruit 30 fully analyzable patients per arm.
Patients will be randomized 1:1 to each study arm . Block randomization will be implemented, using random permuted block sizes of 6, 8, or 10, allowing for up to 15% additional participants beyond the original sample size to account for dropouts. Randomization will also be stratified by sex to ensure a balance of women and men in each arm. Assessments will take place at baseline, midway through therapy at 4 weeks, and after completing the program at 8 weeks (a standard treatment length for VR trials).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SynerGI | Experimental | The standardized CBT program (SynerGI) 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 5-20 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. |
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| Sham VR | Sham Comparator | Patients in the sham 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 SynerGI arm, people in the sham VR group will be prompted to regularly use the headset each week for the 8-week treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SynerGI | Device | Standardized 8-week CBT program, used for 20-30 minutes per week |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Abdominal Pain Severity | Abdominal pain severity as measured by the 5-item PROMIS Abdominal Pain Severity scale. The scale is rendered using a T-statistic, where a score of 50 represents the population mean and 10 points is a SD. | Weekly; Baseline through Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| IBS-Symptom Severity Scale (IBS-SSS) | IBS symptom severity as measured by the IBS-SSS. The maximum IBS-SSS score is 500, and patients can be categorized as having mild (75-175), moderate (176-300), and severe (>=300) symptoms. | Baseline, Week 4 and Week 8 |
| IBS Quality of Life (IBS-QOL) |
| Measure | Description | Time Frame |
|---|---|---|
| Visceral Sensitivity Index (VSI) | GI symptom-specific anxiety as measured by the VSI. The VSI is 15 items. | Baseline, Week 4 and Week 8 |
| NIH PROMIS Depression | Perceived depression as measured by the NIH PROMIS Depression scale. The scale is rendered using a T-statistic, where a score of 50 represents the population mean and 10 points is a SD. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher V Almario, MD, MSHPM | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Cleveland Clinic |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 13, 2025 | Dec 2, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Sham VR |
| Device |
Distraction-based VR program with 2D nature videos to be used for 8 weeks, 2-2 times a week for 10 minutes |
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IBS quality of life as measured by the IBS-QOL. The score range for the IBS-QOL is 0 to 100. |
| Baseline, Week 4 and Week 8 |
| Baseline, Week 4 and Week 8 |
| NIH PROMIS Anxiety | Perceived anxiety as measured by the NIH PROMIS Anxiety scale. The scale is rendered using a T-statistic, where a score of 50 represents the population mean and 10 points is a SD. | Baseline, Week 4 and Week 8 |
| Cleveland |
| Ohio |
| 44195 |
| United States |
| D004066 | Digestive System Diseases |