IBS - Irritable Bowel Syndrome
Conditions
Keywords
Virtual Reality, Cognitive Behavioral Therapy
Brief summary
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.
Detailed description
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).
Interventions
Sponsors
The Cleveland Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Christopher Almario
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has been diagnosed by a physician with Rome IV IBS; all subtypes will be included * Has clinically significant abdominal pain as defined as an NIH PROMIS abdominal pain T-score ≥ 55 (0.5 standard deviation \[SD\] above the normalized population mean of 50) * Able to read/write English (SynerGI is currently only available in English) * Owns a compatible android or iOS smartphone, or personal laptop or desktop computer (excluding tablets) to complete surveys and has access to internet and email
Exclusion criteria
* Presents with a condition that interferes with VR usage, including history of seizure, facial injury precluding safe placement of headset, significant visual or hearing impairment that impacts ability to see the VR images or follow audio instructions * Has cognitive impairment that would affect protocol participation * Has a comorbid disorder that may confound the diagnosis of IBS, including celiac disease, inflammatory bowel disease, autoimmune disorders that affect the GI system, history of bowel resection, HIV/AIDS, diabetes with HgA1c \>=7.0, neuroendocrine tumors, microscopic colitis, eosinophilic bowel disease, acute intermittent porphyria, or any other condition that a physician believes can mimic IBS symptoms and undermine diagnostic certitude * Takes standing doses of opioid medications given the often severe impact of opioids on GI motility and potential for pharmacological visceral hyperalgesia * Previously participated in a VR clinical trial * Previously participated in talk therapy * Previously used a VR program to treat their IBS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Abdominal Pain Severity | Weekly; Baseline through Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IBS-Symptom Severity Scale (IBS-SSS) | Baseline, Week 4 and Week 8 | 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. |
| IBS Quality of Life (IBS-QOL) | Baseline, Week 4 and Week 8 | IBS quality of life as measured by the IBS-QOL. The score range for the IBS-QOL is 0 to 100. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Visceral Sensitivity Index (VSI) | Baseline, Week 4 and Week 8 | GI symptom-specific anxiety as measured by the VSI. The VSI is 15 items. |
| NIH PROMIS Depression | Baseline, Week 4 and Week 8 | 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. |
| NIH PROMIS Anxiety | Baseline, Week 4 and Week 8 | 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. |
Countries
United States
Outcome results
None listed