Status:
COMPLETED
Digital Behavioral Interventions in Inflammatory Bowel Disease
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Crohn Disease
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Given the bidirectionality between psychological distress and disease activity in inflammatory bowel disease (IBD), whereby increased psychological distress exacerbates disease activity and vice versa...
Detailed Description
The investigators propose a 1:1 randomized trial design to evaluate the efficacy of iCBT among a population of Black and Latinx IBD patients and to assess factors influencing its implementation. Patie...
Eligibility Criteria
Inclusion
- age ≥ 18 years
- race/ethnicity self-identified as Black/African American or Hispanic/Latino
- established diagnosis of Crohn's disease or ulcerative colitis
- elevated psychological distress: at least one T-score within two standard deviations above the mean in the domains of anxiety or depression on the National Institutes of Health Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) with or without a T-score within two standard deviations above the mean for perceived stress on the National Institute of Health Toolbox Perceived Stress Scale (Perceived Stress Scale)
- internet access (smartphone/mobile device with data plan, computer with internet)
- ability to provide informed consent in English or Spanish
Exclusion
- PROMIS-29 anxiety or depression T-scores in the severe range (above 2 standard deviations)
- Current suicidal ideation, past suicidal attempt or hospitalization
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04861597
Start Date
November 1 2021
End Date
March 22 2023
Last Update
September 19 2024
Active Locations (1)
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1
Montefiore Hutchinson Campus
The Bronx, New York, United States, 10461