VR Therapies for IBD

Официальное название

AI-Enhanced Virtual Reality Cognitive Behavioral Therapy to Reduce Anxiety and Improve Quality of Life in Patients With Inflammatory Bowel Disease: A Multicenter Pilot and Feasibility Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Distraction VR
  Distraction-based VR program with 2D nature videos to be used for 8-weeks for 10-20 minutes per week.
• Устройство VR/AI CBT
  8-week protocolized VR/AI CBT program

Первичные конечные точки

• Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: Bi-weekly; Baseline through Week 8]
• System Usability Scale (SUS) [Срок оценки: Week 8]

Вторичные конечные точки (5)

• Short Inflammatory Bowel Disease Questionnaire (SIBD-Q) [Срок оценки: Baseline, Week 4, and Week 8]
• Patient Reported Outcome 2 (PRO2 for Ulcerative Colitis) [Срок оценки: Baseline, Week 4, and Week 8]
• Patient Reported Outcome 3 (PRO3 for Crohn's Disease) [Срок оценки: Baseline, Week 4, and Week 8]
• 29-item Patient Reported Outcomes Measurement System v2.1(PROMIS-29) [Срок оценки: Baseline, Week 4, and Week 8]
• Visceral Sensitivity Index (VSI) [Срок оценки: Baseline, Week 4, and Week 8]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Cedars-Sinai Medical Center — Los Angeles
• University of Chicago — Chicago

Идентификаторы

NCT: NCT07590518 · STUDY00004302 · 1R01DK144719-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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