Virtual Reality for Irritable Bowel Syndrome

No longer recruiting at 1 trial location

Overseen By Omer Liran, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Anthony Lembo

Must not be taking: Opioids

Disqualifiers: Celiac, IBD, Diabetes, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how virtual reality (VR) can enhance life for people with irritable bowel syndrome (IBS). Researchers compare two types of VR experiences: an immersive, disease-targeted program and a non-immersive program. The goal is to determine which is more effective at improving the well-being of those with IBS. Suitable participants experience regular IBS symptoms such as constipation, diarrhea, or both. As an unphased trial, this study provides a unique opportunity for patients to explore innovative VR treatments that could improve their quality of life.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using regular doses of opioid medications, you will be excluded from the trial.

What prior data suggests that this virtual reality program is safe for IBS patients?

Research shows that virtual reality (VR) therapy, particularly when combined with cognitive behavioral therapy (CBT), could effectively treat irritable bowel syndrome (IBS). Studies have found CBT to be both effective and safe for IBS. While detailed safety information for VR treatments in IBS is lacking, VR is generally regarded as a safe and well-tolerated therapeutic method. The available research reports no serious side effects from using VR therapy for IBS, suggesting it could be a comfortable and low-risk option for managing IBS symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for irritable bowel syndrome (IBS), which often include medications like antispasmodics and dietary changes, the Virtual Reality (VR) approach is a whole new ballgame. This treatment is unique because it uses immersive VR experiences to potentially alleviate IBS symptoms by addressing the brain-gut connection, which is thought to play a key role in IBS. Researchers are excited about VR for IBS because it offers a non-invasive, drug-free alternative that might reduce stress and anxiety, common triggers for IBS flare-ups. Plus, VR can be easily accessed and personalized, offering a tailored experience that could lead to better symptom management and improved quality of life.

What evidence suggests that this trial's virtual reality treatments could be effective for IBS?

Research has shown that virtual reality (VR) can help treat irritable bowel syndrome (IBS). Studies have found that combining VR with cognitive behavioral therapy (CBT) reduces stomach pain, a common IBS symptom. This trial will compare two different VR programs: the IBS/VR Program (SynerGI) and a Sham VR Program. The IBS/VR Program aims to improve the physical, mental, and social well-being of IBS patients. In an eight-week program called IBS VR, participants reported better control of their symptoms, including pain. These results suggest that VR could be a promising treatment for people with IBS. ^{1 2 4 6 7}

Who Is on the Research Team?

Anthony Lembo, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with Irritable Bowel Syndrome (IBS). Specific eligibility criteria are not provided, but typically participants would need a confirmed diagnosis of IBS and may be required to meet certain health conditions.

Inclusion Criteria

English-speaking

I have been diagnosed with IBS according to Rome IV criteria.

Exclusion Criteria

No WiFi at home

Inability to understand English at 6th grade level

I do not have any other health conditions that could be confused with IBS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Remote assessment

Treatment

Participants undergo an 8-week virtual reality program, either disease-targeted or sham

8 weeks

Remote participation

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Remote follow-up

Qualitative Interview

Optional semi-structured interview to understand participant experiences with VR treatment

30 minutes

Remote interview

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality (VR)

Trial Overview The study is testing the effectiveness of an immersive virtual reality program designed for IBS patients. It compares this program to a non-immersive VR experience over eight weeks, measuring improvements in health-related quality of life.

How Is the Trial Designed?

Group I: IBS/VR Program (SynerGI) Experimental Treatment 1 Intervention

Group II: Sham VR Program Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Anthony Lembo

Lead Sponsor

Trials

2

Recruited

340+

Cedars-Sinai Medical Center

Collaborator

Trials

523

Recruited

165,000+

Published Research Related to This Trial

The implementation of the ADR-RS-IHIS tool significantly increased the reporting of adverse drug reactions (ADRs) in a hospital setting, with reports rising from 0 before 2004 to 0.91 per month in Phase I and 1.62 in Phase II.

Key improvements, such as allowing nurses to report ADRs and automating data entry, enhanced the system's efficacy, demonstrating that integrating ADR reporting into electronic health systems can effectively boost postmarketing drug surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an adverse drug reaction electronic reporting system integrated into a hospital information system. Ortega, A., Aguinagalde, A., Lacasa, C., et al.[2019]

The study developed ADEpedia-on-OHDSI, an informatics platform that integrates FDA's Adverse Event Reporting System (FAERS) data into a standardized format, allowing for improved pharmacovigilance research with a total of 4,619,362 adverse event cases processed.

Mapping accuracy for drug names was high at 96%, and the platform successfully detected triptan-related vascular event signals, demonstrating that combining spontaneous reporting and electronic health record data can enhance signal detection in drug safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ADEpedia-on-OHDSI: A next generation pharmacovigilance signal detection platform using the OHDSI common data model. Yu, Y., Ruddy, KJ., Hong, N., et al.[2020]

The IBS/VR program, designed to help patients with irritable bowel syndrome (IBS) through immersive virtual reality experiences, effectively teaches techniques related to the brain-gut axis and cognitive behavioral therapy.

Patient feedback led to 23 software changes, confirming the program's adaptability and relevance, with thematic saturation achieved after 15 interviews, indicating strong acceptance and potential efficacy of this innovative treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative Validation of a Novel VR Program for Irritable Bowel Syndrome: A VR1 Study. Spiegel, BMR., Liran, O., Gale, R., et al.[2022]

In a study of 20 patients with irritable bowel syndrome (IBS), those who received intensive cognitive therapy showed significantly greater reductions in gastrointestinal symptoms compared to those who only monitored their symptoms, with a p-value of .005.

At the end of the treatment, 80% of the cognitive therapy group experienced clinically significant improvement, while only 10% of the symptom monitoring group did, and these benefits were maintained at a 3-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive therapy for irritable bowel syndrome. Greene, B., Blanchard, EB.[2019]

In an open clinical trial involving 10 Vietnam combat veterans with PTSD, virtual reality exposure therapy (VRE) led to a statistically significant reduction in PTSD symptoms at a 6-month follow-up, with reductions ranging from 15% to 67% for all participants.

The therapy was effective across all symptom clusters of PTSD, indicating that VRE could be a promising alternative treatment for veterans, although self-reported symptoms showed mixed results at the 6-month mark.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy for Vietnam veterans with posttraumatic stress disorder. Rothbaum, BO., Hodges, LF., Ready, D., et al.[2019]

The mobile game-based VR rehabilitation program (MoU-Rehab) significantly improved upper extremity function in stroke patients compared to conventional therapy, as measured by the Fugl-Meyer Assessment and other metrics.

The program was well-tolerated with no adverse effects reported, and patients expressed high satisfaction, indicating its feasibility as a rehabilitation tool for upper limb recovery after ischemic stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile game-based virtual reality rehabilitation program for upper limb dysfunction after ischemic stroke. Choi, YH., Ku, J., Lim, H., et al.[2019]

Virtual reality therapy has shown significant promise in treating various mental health disorders, particularly anxiety disorders and posttraumatic stress disorder, providing a new avenue for assessment and treatment.

While evidence supports its effectiveness in addiction and eating disorders through cue exposure therapy, there is limited data on its efficacy for generalized anxiety disorder and obsessive-compulsive disorder, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Therapy in Mental Health. Emmelkamp, PMG., Meyerbröker, K.[2021]

Virtual Reality (VR) interventions have been shown to significantly reduce symptoms of various anxiety disorders in adults, making them a promising alternative to traditional exposure therapy.

These VR treatments are generally well-accepted by clients and have minimal side effects, although caution is advised for Combat-Related PTSD in Vietnam veterans, indicating the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality interventions for the treatment of anxiety disorders: A scoping review. Andersen, NJ., Schwartzman, D., Martinez, C., et al.[2023]

The introduction of the consumer voluntary reporting form (ConVR) in mid-2013 significantly improved the quality of consumer reports submitted to the FDA, with a notable increase in the completeness of key data fields such as race/ethnicity and medical history.

Following the implementation of the ConVR, there was a substantial increase in the quantity of consumer reports, with an immediate rise of 499 reports in the month after its launch, indicating enhanced engagement from consumers in reporting adverse drug experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a New Consumer Form on the Quantity and Quality of Adverse Event Reports Submitted to the United States Food and Drug Administration. Muñoz, MA., Delcher, C., Dal Pan, GJ., et al.[2020]

The term 'drug ineffective' (DI) was the most commonly reported adverse event in the FDA's FAERS database, accounting for 6.4% of all reports from September 2012 to August 2016, with most reports coming from consumers and primarily from the USA.

Despite the high frequency of DI reports, only 7.8% of evaluated reports were considered 'useful' for pharmacovigilance, indicating a need for better strategies to identify valuable information within these reports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evaluation of "Drug Ineffective" Postmarketing Reports in Drug Safety Surveillance. Misu, T., Kortepeter, CM., Muñoz, MA., et al.[2020]

From 1969 to 2002, the FDA's Adverse Event Reporting System documented about 2.3 million reports of adverse drug reactions across approximately 6000 marketed drugs, highlighting its role in drug safety surveillance.

Over this period, more than 75 drugs were withdrawn from the market due to safety concerns, and 11 drugs required special prescription or distribution restrictions, demonstrating the system's effectiveness in identifying serious safety issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactions. Wysowski, DK., Swartz, L.[2022]

A pilot study involving 31 participants found that a CBT-based self-management website for irritable bowel syndrome (IBS) was positively received, particularly for practical lifestyle advice, although engagement varied among users.

Participants who received nurse support reported better engagement with the cognitive aspects of CBT, suggesting that combining online resources with some level of personal support could enhance the effectiveness of such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring patients' views of a cognitive behavioral therapy-based website for the self-management of irritable bowel syndrome symptoms. Tonkin-Crine, S., Bishop, FL., Ellis, M., et al.[2022]

Participants with psychosis reported significant improvements in managing agoraphobic avoidance after using gameChange VR therapy, particularly those with severe avoidance, highlighting its efficacy as a therapeutic tool.

The immersive VR scenarios allowed users to confront their anxieties in a safe environment, enabling them to learn new coping strategies and gradually apply these skills in real-world situations, suggesting a promising mechanism for anxiety reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Safe Place to Learn: Peer Research Qualitative Investigation of gameChange Virtual Reality Therapy. Bond, J., Kenny, A., Pinfold, V., et al.[2023]

Disorders of gut-brain interaction (DGBIs), such as functional dyspepsia and irritable bowel syndrome (IBS), are common and significantly impact patients' quality of life, highlighting the need for effective treatments.

Recent studies suggest that virtual reality (VR) technology may be a promising novel therapy for alleviating chronic abdominal pain associated with DGBIs, potentially offering a non-invasive alternative to traditional pain management methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality: A New Treatment Paradigm for Disorders of Gut-Brain Interaction? Lacy, BE., Cangemi, DJ., Spiegel, BR.[2023]

The study is a randomized controlled trial involving 300 participants to evaluate the efficacy of the Zemedy app, a CBT-based intervention for irritable bowel syndrome (IBS), over an 8-week treatment period.

The primary outcomes will assess gastrointestinal symptom severity and health-related quality of life (HRQL), with the hypothesis that Zemedy will significantly reduce IBS symptoms and improve HRQL compared to an active control app.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and efficacy of the Zemedy app versus a relaxation training and meditation app for IBS: protocol for a randomised controlled trial. Hunt, MG., Dalvie, A., Ipek, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11401788/

The Role of Virtual Reality in the Management of Irritable ... This article explores the potential role of virtual reality (VR)-based cognitive behavioral therapy (CBT) in treating patients with IBS.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06687616

Study Details | NCT06687616 | RCT of VR Therapy for IBS It is hypothesized that using VR-administered CBT may reduce abdominal pain, leading to improved overall physical, psychological, and social functioning when ...

3. reporter.nih.gov reporter.nih.gov/project-details/11140550

Project Details - NIH RePORTER sham VR among patients with IBS. If this pilot study demonstrates that the VR CBT program is both feasible and meaningfully improves IBS symptoms, it will ...

4. withpower.com withpower.com/trial/phase-irritable-bowel-syndrome-11-2024-d986b?condition=ibs&hasNoPlacebo=false&overallStatus=Recruiting

VR Therapy for Irritable Bowel Syndrome It is hypothesized that using VR-administered CBT may reduce abdominal pain, leading to improved overall physical, psychological, and social functioning when ...

5. cedars-sinai.org cedars-sinai.org/newsroom/study-virtual-reality-helps-ibs-patients/

Study: Virtual Reality Helps IBS Patients The eight-week program, known as IBS VR, makes use of cognitive behavioral therapy (CBT) to help patients manage symptoms such as pain and ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06687616/rct-of-vr-therapy-for-ibs

RCT of VR Therapy for IBS | Clinical Research Trial Listing It is hypothesized that using VR-administered CBT may reduce abdominal pain, leading to improved overall physical, psychological, and social ...

7. withpower.com withpower.com/trial/phase-irritable-bowel-syndrome-1-2024-00f8c

Virtual Reality for Irritable Bowel Syndrome The provided research does not contain specific safety data for Virtual Reality treatments for Irritable Bowel Syndrome. The studies focus on adverse event ...