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NCT05377840 · ClinicalTrials.gov registry record · NA
Use of Psychologist-administered Cognitive Behavioral Therapy (CBT) or Self-administered CBT for the Treatment of Anxiety and/or Depression in Inflammatory Bowel Disease (IBD)
A NA study of Crohn Disease and Ulcerative Colitis (UC), sponsored by Yale University.
- Recruiting
- Registry status
- NA
- Development phase
- 152
- Enrollment target
- 1
- Study location
NCT05377840: Recruiting NA study of Crohn Disease and Ulcerative Colitis (UC), sponsored by Yale University.
NCT05377840 is a NA study of Crohn Disease and Ulcerative Colitis (UC) that is actively recruiting participants, run by Yale University. The registered enrollment target is 152 participants, below the 203-participant average among 71 other Crohn Disease trials with a reported enrollment target (25% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05377840, a NA study of Crohn Disease and Ulcerative Colitis (UC), is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- NA
- Development phase
- 152 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective, single center, randomized treatment study to assess if anxiety and depression in participants with IBD can be improved with CBT compared to those treated with SKY.
Primary Outcome
Change from baseline in anxiety using GAD-7 compared to week 6, week 12 and week 24 (post treatment). Generalized Anxiety Disorder-7 questionnaire is a 7-item validated questionnaire used to screen for anxiety with a range of scores from 0-3. A cumulative score of ≥8 is considered positive for anxiety with lower scores indicating no or mild anxiety.
Conditions Studied
Interventions
- BEHAVIORAL Psychologist-administered Cognitive Behavioral Therapy
- BEHAVIORAL Self-Administered Cognitive Behavioral Therapy
Study Locations (1)
Connecticut
- Yale New Haven Hospital - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2022-07-05 |
| Est. Completion | 2025-12 |
| Phase | NA |
What NCT05377840 shows while recruiting
NCT05377840 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, below the 203-participant average among 71 other Crohn Disease trials with a reported enrollment target (25% lower).
The record links to 2 conditions, with Crohn Disease appearing as the primary indexed condition, and to 2 interventions - of which Psychologist-administered Cognitive Behavioral Therapy is the first listed.
NCT05377840 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT05377840 about?
NCT05377840 is a clinical study titled "Use of Psychologist-administered Cognitive Behavioral Therapy (CBT) or Self-administered CBT for the Treatment of Anxiety and/or Depression in Inflammatory Bowel Disease (IBD)". This is a prospective, single center, randomized treatment study to assess if anxiety and depression in participants with IBD can be improved with CBT compared to those treated with SKY.
What is the current status of trial NCT05377840?
This trial is currently recruiting. It is a NA study. The enrollment target is 152 participants. The study started on 2022-07-05. Estimated completion is 2025-12.
What conditions does trial NCT05377840 study?
This clinical trial studies the following conditions: Crohn Disease, Ulcerative Colitis (UC).
What interventions are being tested in trial NCT05377840?
The interventions under investigation include: Psychologist-administered Cognitive Behavioral Therapy (BEHAVIORAL), Self-Administered Cognitive Behavioral Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT05377840?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05377840 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Crohn Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05377840's enrollment target sits among peer trials
152 26th of 71 higher than 46 of 71 other Crohn Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn Disease 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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