RCT of VR Therapy for IBS

Launched by CHRISTOPHER ALMARIO · Nov 12, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring whether a special program using virtual reality (VR) can help people with Irritable Bowel Syndrome (IBS) feel better. The study compares a VR therapy that uses techniques from cognitive behavioral therapy (CBT) to a dummy version of VR that doesn't provide real treatment. Researchers believe that the VR therapy might help reduce abdominal pain and improve overall well-being, including physical health, mental health, and social interactions.

To participate, individuals need to be diagnosed with IBS and experience significant abdominal pain. They should also be able to read and write in English and have access to a smartphone or computer with internet. However, people with certain medical conditions that affect VR use, or those who take specific medications, won't be eligible. If chosen, participants will engage with the VR therapy and share their experiences, helping researchers understand if this new approach could be beneficial for managing IBS symptoms.

Gender

ALL

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