Actively Recruiting
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)
Led by Yale University · Updated on 2025-02-17
152
Participants Needed
1
Research Sites
177 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
C
Crohn's & Colitis Foundation of America (CCFA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Verified diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- Stable IBD treatment with no active intestinal inflammation based on normal tests or imaging
- Meet criteria for anxiety or depression based on screening questionnaires
- Stable doses of anxiety and/or depression medications for at least 12 weeks prior to screening, if applicable
- Willing to maintain stable medication doses during the study
- May have both anxiety and depression; assignment based on more severe symptoms
You will not qualify if you...
- Decline to participate for the full study duration
- Active intestinal inflammation based on elevated tests or imaging
- Non-English speaker
- Presence of suicidal thoughts or severe mental illness requiring emergency psychiatric care
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
Actively Recruiting
Research Team
J
Jill Gaidos, MD, FACG
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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