Clinical trial NCT06687616: RCT of VR Therapy for IBS
Official title: Randomized Controlled Trial of Virtual Reality Therapies for Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
Keywords: Virtual Reality
Cognitive Behavioral Therapy
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-11-13
Enrollment: 72
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: PROMIS Abdominal Pain Severity
timeFrame: Weekly; Baseline through Week 8
Secondary outcomes:
measure: IBS-Symptom Severity Scale (IBS-SSS)
timeFrame: Baseline, Week 4 and Week 8
measure: IBS Quality of Life (IBS-QOL)
timeFrame: Baseline, Week 4 and Week 8
Other outcomes:
measure: Visceral Sensitivity Index (VSI)
timeFrame: Baseline, Week 4 and Week 8
measure: NIH PROMIS Depression
timeFrame: Baseline, Week 4 and Week 8
measure: NIH PROMIS Anxiety
timeFrame: Baseline, Week 4 and Week 8
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Christopher V Almario, MD, MSHPM
role: PRINCIPAL_INVESTIGATOR
References: