Efficacy of Virtual Reality (VR) for Irritable Bowel Syndrome

Anthony Lembo

Overview

In this study, the investigators conduct a remote, eight-week, two-arm, randomized controlled trial that assesses the benefits, primarily measured through the irritable bowel syndrome (IBS)-targeted HRQOL (health-related quality of life), of an immersive, disease-targeted virtual reality program compared to a non-immersive virtual reality program for patients with IBS.

In this study, the investigators will conduct a decentralized, remote, eight-week, two-arm, randomized controlled trial of SynerGI, a disease-targeted, brain-gut directed, immersive VR program for people with IBS, versus sham VR delivered in a VR headset. Eligible participants will be assigned to a study arm using a 1:1 random number generator and will be blinded to allocation. Data analysts will also be blinded to allocation; only pre-specified staff who are uninvolved with data analyses will be unblinded for purposes of study administration (e.g., sending allocation-specific study materials). After completion of the treatment, participants will be invited to participate in an optional 30-minute semi-structured interview to better understand their experiences of VR treatment. Qualitative interviews will be audio-recorded and transcribed. The primary aim of this study will be to assess the benefits of disease-targeted VR compared to sham VR on clinically relevant outcomes. The second aim will seek to determine patient-level predictors of treatment response to active VR therapy. The third aim will seek to understand patient experiences of VR to better inform the design of VR treatments for digestive diseases in the future.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Conditions

IBS - Irritable Bowel Syndrome

Interventions

Virtual Reality HeadsetDEVICE

Participants will be mailed a Meta Quest 2 Headset. Participants will be asked to wear and use the VR headset for around 20 minutes each day for 8 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * English-speaking * 18 years or older * Meet Rome IV criteria, as diagnosed either by a licensed physician or via self-report using the Rome IBS questionnaire, for IBS for any type: IBS-C (IBS with constipation), IBS-D (IBS with diarrhea), and IBS-M (mixed-type IBS) Exclusion Criteria: * Individuals with 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 ( human immunodeficiency virus/acquired immunodeficiency syndrome) * diabetes with HgA1c\>7.0 * neuroendocrine tumors * microscopic colitis * lactase deficiency * eosinophilic bowel disease * acute intermittent porphyria * any other condition that a licensed physician believes can mimic IBS symptoms and undermine diagnostic certitude * Patients using regular doses of opioid medications will also be excluded given the often-severe impact of opioids on GI motility and potential for pharmacological visceral hyperalgesia * No WiFi at home * Any history of seizure * Ongoing treatment for a GI cancer * Major audiovisual impairment (complete blindness, deafness) * Inability to understand English at 6th grade level * Any events planned over the 8 weeks of the study that could end your ability to participate in the study, such as a medical procedure, vacation, or change in residence (Note: the study team can always delay enrollment)

Locations (2)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

IBS-targeted HRQOL (health-related quality of life)

The primary outcome will be an increase in IBS-QOL (quality of life) scores between baseline and week 8 for those on the study arm. Each question is positively scored 1-5, and the sum is normalized into a 0-100 score, with 100 being the highest reported quality of life and 0 being the lowest.

Time frame: Baseline, after 4 weeks using device, after 8 weeks using device

Secondary Outcomes

GI (Gastrointestinal) Pain Intensity

A secondary outcome will be a decrease in PROMIS (Patient Reported Outcomes Measurement Information System) GI Pain scores scored on a scale of 1-5 with 1 being low pain intensity and 5 being high. These scores are summed for a raw score, which may be converted into a T-score.

Time frame: Baseline, after 4 weeks using device, after 8 weeks using device

IBS symptom severity

A secondary outcome will be a decrease in patient reported IBS Symptom Severity Score (IBS-SSS). Scored on a 0-500 scale. * \< 75 points - IBS considered in remission * 75-174 - mild IBS * 175-299 - moderate IBS * 300-500 - severe IBS 5 measures 1. \# of days with abdominal pain x 10 - maximum score of 100 2. 1-100 scale for abdominal pain severity 3. 0-100 scale for abdominal distension severity 4. 0-100 scale for satisfaction with bowel habits 5. 0-100 scale for interference with life'

Time frame: Weekly for 8 weeks

Visceral anxiety

A secondary outcome will be a decrease in patient reported Visceral Sensitivity Index (VSI) scores. Each question is positively scored 1-6. 1 represents the most visceral anxiety and 6 represents no visceral anxiety. The VSI items then are reversed scored, meaning that the 1-6 becomes 5-0. These reverse scores are then summed. The max score, representing severe visceral anxiety is 75. The minimum score is 0 (no visceral anxiety).

Time frame: Baseline, after 4 weeks using device, after 8 weeks using device

Data from ClinicalTrials.gov

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