VR Therapies for IBD

Brennan Spiegel

Status: Not yet enrolling

Conditions: Inflammatory Bowel Disease (IBD); Ulcerative Colitis (UC); Anxiety; Crohn Disease (CD)

Treatments: Device: Distraction VR; Device: VR/AI CBT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07590518

STUDY00004302

1R01DK144719-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Through a pilot randomized controlled trial (RCT), the aim is to test the clinical impact and feasibility of a AI-enhanced Virtual Reality (VR) Cognitive Behavioral therapy (CBT) program versus distraction VR among patients with inflammatory bowel disease (IBD) and anxiety. It is hypothesized that using VR/AI CBT may reduce anxiety and IBD symptoms, leading to improved overall physical, psychological, and social functioning when compared to distraction VR.

Full description

In this pilot randomized controlled trial (RCT), the investigators aim to test the feasibility and preliminary clinical impact of a novel virtual reality (VR) cognitive behavioral therapy (CBT) program supported by artificial intelligence (AI) vs. distraction VR control among patients with IBD and anxiety.

The investigators will conduct this pilot RCT with 76 participants with with IBD and anxiety to achieve the following aims: Aim 1-Establish the feasibility of using an 8-week VR/AI CBT program among patients with IBD and anxiety; Aim 2-Acquire preliminary data assessing the clinical impact of an 8-week VR/AI CBT program vs. distraction VR control among patients with IBD with anxiety.; Aim 3-Acquire exploratory data assessing the biomarker impact of an 8-week VR/AI CBT program vs. distraction VR control among IBD patients with anxiety.

Participants will be randomized 1:1 to each study arm via the REDCap randomization module with allocation tables created by PASS. Block randomization will be used with random permuted block sizes of 6, 8, or 10, accounting for 20% additional subjects from the original sample size to allow for dropouts. The investigators will stratify randomization by sex to ensure balance in each arm. The investigators will also stratify randomization by current use of psychotropic or mental health medications/ prior psychotherapy to maintain balance.

Assessments will be performed at baseline and bi-weekly during the 8-week study period; this is a common treatment length for VR trials. While IBD is a chronic disease, the investigators must first assess the potential efficacy of the 8-week intervention in this pilot trial before evaluating durability in a definitive efficacy RCT.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stated willingness to comply with all study procedures, VR therapy regimen, and availability for the duration of the study
• Age of 18 years or older
• Confirmed diagnosis of IBD with concurrent anxiety, defined as a GAD-7 score of ≥10
• Ability to read and write in English (VR/AI CBT program is currently only available in English)
• Access to an internet-enabled device (android or iOS smartphone, or personal laptop or desktop computer) to complete surveys and has access to internet and email complete baseline and assessment surveys.

Exclusion criteria

• Have a condition that interferes with the safe use of VR usage, such as history of seizures, facial injuries precluding headset placement, significant visual or hearing impairment that impacts ability to see the VR images or follow audio instructions
• Have cognitive impairments that would affect protocol participation.
• Currently engaged in psychotherapy (Patients who are taking medications for anxiety or have previously engaged in psychotherapy but are not currently in therapy will remain eligible).
• Have had an IBD related surgery (including perianal surgery) within the past 6 months or anticipated in the next 6 months
• Anticipated to change their IBD inflammatory treatment during the study period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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76 participants in 2 patient groups

VR/AI CBT

Experimental group

Description:

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.

Treatment:

Device: VR/AI CBT

Distraction VR

Sham Comparator group

Description:

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.

Treatment:

Device: Distraction VR