Clinical trial NCT06257472: Efficacy of Virtual Reality (VR) for Irritable Bowel Syndrome
Official title: Efficacy of Virtual Reality (VR) for Irritable Bowel Syndrome: A Randomized Trial Comparing Brain-Gut Directed VR vs. Sham VR
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
Keywords: Virtual Reality
IBS
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Cedars-Sinai Medical Center
First posted: 2024-02-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-armed blinded clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: IBS-targeted HRQOL (health-related quality of life)
timeFrame: Baseline, after 4 weeks using device, after 8 weeks using device
Secondary outcomes:
measure: GI (Gastrointestinal) Pain Intensity
timeFrame: Baseline, after 4 weeks using device, after 8 weeks using device
measure: IBS symptom severity
timeFrame: Weekly for 8 weeks
measure: Visceral anxiety
timeFrame: Baseline, after 4 weeks using device, after 8 weeks using device
measure: Generalized anxiety
timeFrame: Baseline, after 4 weeks using device, after 8 weeks using device
measure: Maladaptive GI (Gastrointestinal) cognitions
timeFrame: Baseline, after 4 weeks using device, after 8 weeks using device
measure: Somatization
timeFrame: Baseline, after 4 weeks using device, after 8 weeks using device
measure: Increase in Symptom Relief
timeFrame: End of Study, which will occur after 8 weeks using device
measure: Optional Individual Cognitive Interviews
timeFrame: End of Study, which will occur after 8 weeks using device
measure: Optional Rome IV Criteria assessment
timeFrame: At screening/baseline
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Anthony Lembo, MD
role: PRINCIPAL_INVESTIGATOR
References: