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NCT04861597 · ClinicalTrials.gov registry record · NA
Digital Behavioral Interventions in Inflammatory Bowel Disease
A NA study of Ulcerative Colitis and Crohn Disease, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04861597: Completed NA study of Ulcerative Colitis and Crohn Disease, sponsored by Montefiore Medical Center.
NCT04861597 is a NA study of Ulcerative Colitis and Crohn Disease that has completed, run by Montefiore Medical Center. The registered enrollment target is 30 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04861597, a NA study of Ulcerative Colitis and Crohn Disease, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Level of psychological distress in participants over the prior 7 days was measured by combining the sub-score domains of anxiety and depression from the National Institutes of Health Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) assessment tool. PROMIS-29 is a 29-item form that includes 4 questions in each of the domains of anxiety and depression. Group mean scores of these 8 items are composited. Higher scores indicate a greater level of the measured trait, and raw sco
Conditions Studied
Interventions
- BEHAVIORAL Internet based cognitive behavioral therapy
- BEHAVIORAL Digital mood tracking
Study Locations (1)
New York
- Montefiore Hutchinson Campus - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-11-01 |
| Est. Completion | 2023-03-22 |
| Phase | NA |
What the finished NCT04861597 record still lists
NCT04861597 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (99% lower).
The record links to 5 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Internet based cognitive behavioral therapy is the first listed.
NCT04861597 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04861597 about?
NCT04861597 is a clinical study titled "Digital Behavioral Interventions in Inflammatory Bowel Disease". 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 intervention...
What is the current status of trial NCT04861597?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2021-11-01. Estimated completion is 2023-03-22.
What conditions does trial NCT04861597 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Crohn Disease, Inflammatory Bowel Diseases, Stress, Psychological, Depression, Anxiety.
What interventions are being tested in trial NCT04861597?
The interventions under investigation include: Internet based cognitive behavioral therapy (BEHAVIORAL), Digital mood tracking (BEHAVIORAL).
Who is sponsoring clinical trial NCT04861597?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04861597 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04861597's enrollment target sits among peer trials
30 103rd of 122 higher than 18 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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