Virtual Reality Therapy for Inflammatory Bowel Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a special virtual reality therapy can assist people with inflammatory bowel disease (IBD) who also experience anxiety. The study compares two types of VR experiences: one using cognitive behavioral therapy (CBT) techniques and another offering relaxing nature scenes. Researchers aim to determine if the CBT approach reduces anxiety and IBD symptoms more effectively than the relaxation scenes. Individuals diagnosed with IBD and anxiety who are comfortable using VR at home might be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future treatment options for IBD and anxiety.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, it mentions that you should not anticipate changing your IBD treatment during the study.
What prior data suggests that this VR/AI CBT program is safe for patients with inflammatory bowel disease?
Research has shown that virtual reality (VR) therapy is generally well-received by people with inflammatory bowel disease (IBD). Many studies have found that patients are comfortable with VR programs and can complete them without issues. For instance, one study reported that over 75% of participants finished the VR program and its assessments, indicating that the therapy rarely causes side effects that would lead someone to stop.
VR has also been safely used in other medical areas, such as managing pain and anxiety. Although the specific VR/AI cognitive behavioral therapy (CBT) program being tested is new, VR has proven safe and effective in similar healthcare applications.
While these studies suggest that VR therapy is safe, individual experiences may vary. Prospective participants should discuss any concerns with the trial team. They can provide detailed information about what to expect and how they will ensure safety during the trial.12345Why are researchers excited about this trial?
Researchers are excited about the VR/AI CBT treatment for inflammatory bowel disease (IBD) because it offers a novel way to manage symptoms through virtual reality. Unlike conventional treatments such as medication or dietary changes, this approach uses an immersive digital environment to teach cognitive-behavioral therapy (CBT) skills, which can be practiced in real life. Delivered via the Meta Quest 2 headset, this method is self-administered, allowing patients to learn and progress from home. Additionally, the program is supported by smartphone or computer-based exercises, making it accessible and convenient. This innovative treatment could provide a new, engaging option for people with IBD, focusing on mental well-being alongside physical health.
What evidence suggests that this trial's treatments could be effective for IBD and anxiety?
Research has shown that virtual reality (VR) therapy could help manage anxiety and symptoms in people with inflammatory bowel disease (IBD). In this trial, participants will join one of two groups. One group will receive VR combined with cognitive behavioral therapy (CBT), known as VR/AI CBT, which studies indicate can reduce anxiety and pain. This method aims to enhance the overall well-being of IBD patients, including their physical, mental, and social health. The other group will receive a distraction-based VR therapy program as a sham comparator. Previous research suggests that VR therapy is effective and well-received by patients, offering a new way to support traditional treatments. While more research is needed, early evidence suggests that VR/CBT could be a useful tool for managing anxiety and symptoms related to IBD.12356
Who Is on the Research Team?
Brennan Spiegel, MD, MSHS
Principal Investigator
Cedars-Sinai Medical Center
David Rubin, MD
Principal Investigator
University of Chicago
Are You a Good Fit for This Trial?
This trial is for people diagnosed with inflammatory bowel disease (like Crohn's or ulcerative colitis) who also experience anxiety. Participants should be able to use virtual reality technology and meet any other basic health requirements set by the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo an 8-week VR/AI CBT program or distraction VR therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- VR/AI CBT
Trial Overview
The study compares two types of virtual reality therapy: one uses AI-enhanced VR cognitive behavioral therapy (CBT), and the other uses distraction-based VR. Patients are randomly assigned to either group to see which helps more with anxiety and IBD symptoms.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
The VR/AI CBT program will be delivered through the Meta Quest 2 device and is self-administered and includes a network of environments arranged in a virtual clinic that participants experience at home though a protocolized, 8-week program. Depending on the module, experiences within the program last between 10-20 minutes. Participants will be prompted to regularly use the headset each week over the 8-week study period. The VR modules are reinforced with regularly scheduled messages and CBT exercises delivered by a webapp that is available on any smartphone or computer. The program progressively builds new skills and culminates in transitioning from using VR to applying the skills learned in VR to everyday life.
Participants in the distraction VR group will receive the same Meta Quest 2 device but will only have access to a distraction-based VR therapy program that includes 2D nature videos (e.g., relaxing on a beach, swimming with dolphins). Similar to the VR/AI CBT arm, people in the distraction VR group will be prompted to regularly use the headset each week for the 8-week treatment period.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brennan Spiegel
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Chicago
Collaborator
Citations
The role of virtual reality in managing inflammatory bowel ...
Virtual reality (VR) has emerged as a promising tool in managing psychological comorbidities and enhancing the overall care of patients with IBD.
Outpatient VR (Virtual Reality)-Brain-gut Behavioral ...
the study will achieve greater than 75% program completion and 75% study assessment completion; patients with IBD will find VR-directed BGBT acceptable as an ...
VR Therapies for IBD - ClinicalTrials.Veeva
It is hypothesized that using VR/AI CBT may reduce anxiety and IBD symptoms, leading to improved overall physical, psychological, and social ...
Virtual Reality Therapy for Inflammatory Bowel Disease
... VR/AI CBT will have tolerable side effects & efficacy for patients with Anxiety, Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease ...
Evaluation of a virtual reality-directed brain-gut behavioural ...
In this study, we aim to establish feasibility and acceptability for a VR-directed BGBT inpatient programme for patients with IBD.
Outpatient VR (Virtual Reality)-Brain-gut Behavioral ...
This research study is being done to learn if a virtual reality (VR)-directed BGBT program is feasible and acceptable for patients to ...
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