Anxiety, Crohn Disease (CD), Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC)
Conditions
Keywords
Virtual Reality, Cognitive Behavioral Therapy
Brief summary
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.
Detailed 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.
Interventions
DEVICEDistraction VR
Distraction-based VR program with 2D nature videos to be used for 8-weeks for 10-20 minutes per week.
DEVICEVR/AI CBT
8-week protocolized VR/AI CBT program
Sponsors
Brennan Spiegel
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder-7 (GAD-7) | Bi-weekly; Baseline through Week 8 | 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. |
| System Usability Scale (SUS) | Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcome 3 (PRO3 for Crohn's Disease) | Baseline, Week 4, and Week 8 | 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. |
| 29-item Patient Reported Outcomes Measurement System v2.1(PROMIS-29) | Baseline, Week 4, and Week 8 | 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. |
| Visceral Sensitivity Index (VSI) | Baseline, Week 4, and Week 8 | 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). |
| Short Inflammatory Bowel Disease Questionnaire (SIBD-Q) | Baseline, Week 4, and Week 8 | 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. |
| Patient Reported Outcome 2 (PRO2 for Ulcerative Colitis) | Baseline, Week 4, and Week 8 | 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. |
Countries
United States
Contacts
CONTACTKarisma K Suchak, MD, MSHS
CONTACTSamuel Eberlein, MSHS
PRINCIPAL_INVESTIGATORBrennan Spiegel, MD, MSHS
Cedars-Sinai Medical Center
PRINCIPAL_INVESTIGATORDavid Rubin, MD
University of Chicago
Outcome results
None listed