Efficacy of Virtual Reality (VR) for Irritable Bowel Syndrome: A Randomized Trial Comparing Brain-Gut Directed VR vs. Sham VR
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Enrollment
- 75
- Locations
- 4
- Primary Endpoint
- IBS-targeted HRQOL (health-related quality of life)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
IBS-targeted HRQOL (health-related quality of life)
Time Frame: Baseline, after 4 weeks using device, after 8 weeks using device
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.
Secondary Outcomes
- Visceral anxiety(Baseline, after 4 weeks using device, after 8 weeks using device)
- Increase in Symptom Relief(End of Study, which will occur after 8 weeks using device)
- GI (Gastrointestinal) Pain Intensity(Baseline, after 4 weeks using device, after 8 weeks using device)
- Generalized anxiety(Baseline, after 4 weeks using device, after 8 weeks using device)
- Somatization(Baseline, after 4 weeks using device, after 8 weeks using device)
- Maladaptive GI (Gastrointestinal) cognitions(Baseline, after 4 weeks using device, after 8 weeks using device)
- Optional Individual Cognitive Interviews(End of Study, which will occur after 8 weeks using device)
- Optional Rome IV Criteria assessment(At screening/baseline)
- IBS symptom severity(Weekly for 8 weeks)
Investigators
Anthony Lembo
Vice Chair of Research
The Cleveland Clinic