VR Therapies for IBD
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Samuel Eberlein, MSHS
- Número de teléfono: 310-423-6721
- Correo electrónico: Samuel.Eberlein@cshs.org
Copia de seguridad de contactos de estudio
- Nombre: Karisma K Suchak, MD, MSHS
- Número de teléfono: 310-423-0714
- Correo electrónico: karisma.suchak@cshs.org
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90048
- Cedars-Sinai Medical Center
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Contacto:
- Samuel Eberlein, MSHS
- Número de teléfono: 310-423-6721
- Correo electrónico: Samuel.Eberlein@cshs.org
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Contacto:
- Karisma K Suchak, MD, MSHS
- Número de teléfono: 310-423-0714
- Correo electrónico: karisma.suchak@cshs.org
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Investigador principal:
- Brennan Spiegel, MD, MSHS
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Illinois
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Chicago, Illinois, Estados Unidos, 60637
- University of Chicago
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Investigador principal:
- David Rubin, MD
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Contacto:
- Alexandra McDermott
- Número de teléfono: 847-409-0284
- Correo electrónico: Alexandra.Mcdermott@bsd.uchicago.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: VR/AI CBT
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.
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8-week protocolized VR/AI CBT program
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Comparador falso: Distraction VR
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.
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Distraction-based VR program with 2D nature videos to be used for 8-weeks for 10-20 minutes per week.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Generalized Anxiety Disorder-7 (GAD-7)
Periodo de tiempo: Bi-weekly; Baseline through Week 8
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The GAD-7 is a 7-item scale for screening and assessing the severity of generalized anxiety disorder.
It has a 2-week recall period and is scored on a 0-21 scale-0-4: minimal anxiety; 5-9: mild; 10-14: moderate; 15-21 severe.
It has high reliability and criterion validity across many clinical contexts.
The minimal clinically important difference (MCID) is 4 points.
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Bi-weekly; Baseline through Week 8
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System Usability Scale (SUS)
Periodo de tiempo: Week 8
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The SUS is a validated, widely-used ten-item Likert scale giving a global view of assessments of usability, with each item rated on a scale of 0 to 5. Higher scores indicate greater usability.
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Week 8
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Short Inflammatory Bowel Disease Questionnaire (SIBD-Q)
Periodo de tiempo: Baseline, Week 4, and Week 8
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The SIBDQ is a 10-item, disease-targeted Health-Related Quality of Life (HRQoL) measure that evaluates 4 domains: bowel symptoms, systemic symptoms, emotional function, and social function. Each item is rated on a 7-point Likert scale, with total scores ranging from 10 to 70, higher scores indicate a better HRQoL and fewer IBD symptoms. The SIBDQ has been validated to detect meaningful changes in HRQoL in an outpatient setting. The full version IBDQ, has been validated for its excellent internal consistency, test-retest reliability, and construct validity, distinguishing between active disease and remission, as well as convergent and divergent validity. The IBDQ is widely validated in clinical trials and real-world settings, making it a robust tool for assessing changes in HRQoL. |
Baseline, Week 4, and Week 8
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Patient Reported Outcome 2 (PRO2 for Ulcerative Colitis)
Periodo de tiempo: Baseline, Week 4, and Week 8
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The PRO-2 is a simplified PRO measure used to assess Ulcerative Colitis (UC) activity.
The PRO-2 focuses on rectal bleeding (ranging from 0-3; higher score indicates worse severity of bleeding) and average daily stool frequency.
This tool provides a quick and reliable assessment of patient-reported disease activity.
The PRO-2 has been validated against clinical markers of disease activity, such as endoscopic findings and biomarkers, and is sensitive to detecting changes in UC symptoms.Total PRO-2 scores range from 0 to 6, with higher scores indicating worse ulcerative colitis symptom severity.
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Baseline, Week 4, and Week 8
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Patient Reported Outcome 3 (PRO3 for Crohn's Disease)
Periodo de tiempo: Baseline, Week 4, and Week 8
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The PRO-3 is a simplified PRO measures used to assess Crohn's Disease activity.
The PRO-3 evaluates: abdominal pain (ranging from 0-3 with higher scores indicating worse abdominal pain), stool frequency (number of liquid or soft stools per day), and general well-being (5-point scale ranging from 0-4, higher score indicates worse general well-being).
The PRO-3 has been validated against clinical markers of disease activity, such as endoscopic findings and biomarkers, and is sensitive to detecting changes in Crohn's Disease symptoms.
Higher overall PRO-3 scores indicate worse Crohn's disease symptom severity.
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Baseline, Week 4, and Week 8
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29-item Patient Reported Outcomes Measurement System v2.1(PROMIS-29)
Periodo de tiempo: Baseline, Week 4, and Week 8
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The PROMIS-29 is a validated 29-item questionnaire to assess general Health-Related Quality of Life (HRQoL) and treatment response in individuals with IBD. The assessment includes questions in each of the following domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity. 28 of the items use a 5-point Likert response scale that is T-scored, 1-5 with higher T-scores representing more of the domain measured (higher physical function/ability to participate in social roles and activities= better; higher anxiety/depression/fatigue/sleep disturbance/ pain interference=worse). Pain intensity uses a numeric rating scale, 0 to 10 with higher scores indicating greater pain intensity. |
Baseline, Week 4, and Week 8
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Visceral Sensitivity Index (VSI)
Periodo de tiempo: Baseline, Week 4, and Week 8
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GI symptom-specific anxiety as measured by the VSI.
The VSI is 15 items, rated on 6-point Likert scale ranging from 1 (strongly agree) to 6 (strongly disagree).
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Baseline, Week 4, and Week 8
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Serum C-Reactive Protein (CRP)
Periodo de tiempo: Baseline and Week 8
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A blood test that measures for systemic inflammation.
CRP is a protein made by the liver, and increases when there is inflammation in the body.
This biomarker is routinely used in clinical settings to monitor IBD activity and predict relapses.
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Baseline and Week 8
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Fecal Calprotectin (fCal)
Periodo de tiempo: Baseline and Week 8
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A stool sample that measures for gastrointestinal inflammation.
fCal is released by neutrophils in the intestine during inflammation.
This biomarker is routinely used in clinical settings to monitor IBD activity and predict relapses.
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Baseline and Week 8
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: David Rubin, MD, University of Chicago
- Investigador principal: Brennan Spiegel, MD, MSHS, Cedars-Sinai Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00004302
- 1R01DK144719-01 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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