N/A
N=30
Digital Behavioral Interventions in Inflammatory Bowel Disease
Crohn Disease · Ulcerative Colitis · Inflammatory Bowel Diseases · Stress, Psychological · Depression, Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT04861597 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Level of Psychological Distress — 60.8; 59.4 T-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Internet based cognitive behavioral therapy (Behavioral); Digital mood tracking (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Level of Psychological Distress |
60.8; 59.4 | — |
| SECONDARY Disease Activity by Short Crohn's Disease Activity Index |
118; 134 | — |
| SECONDARY Disease Activity by Simple Clinical Colitis Activity Index |
6; 7 | — |
| SECONDARY Perceived Stress Score |
58; 55 | — |
| SECONDARY Health-related Quality-of-Life |
— | — |
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, psychosocial aspects of IBD care are receiving increased attention. However, proposed interventions are generally resource-intensive and have been tested in majority white populations. While people of color are an increasing segment of the IBD population, they are currently underrepresented in research studies. The purpose of this study is to evaluate the efficacy and implementation of internet-based cognitive behavioral therapy (iCBT) among IBD patients of color with elevated psychological distress.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- PROMIS-29 anxiety or depression T-scores in the severe range (above 2 standard deviations)
- Current suicidal ideation, past suicidal attempt or hospitalization
Data sourced from ClinicalTrials.gov (NCT04861597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.