Status:
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)
Lead Sponsor:
Yale University
Collaborating Sponsors:
Crohn's & Colitis Foundation of America (CCFA)
Conditions:
Crohn Disease
Ulcerative Colitis (UC)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
This is a prospective, single center, randomized treatment study, where participants will be screened for anxiety and depression in an inflammatory bowel disease (Crohn's disease and ulcerative coliti...
Eligibility Criteria
Inclusion
- verified inflammatory bowel disease (Crohn's disease and ulcerative colitis)
- IBD patients on a stable treatment regimen with no evidence of active intestinal inflammation based on either normal c-reactive protein and/or fecal calprotectin, imaging studies, or endoscopy who meet the criteria for anxiety or depression based on the screening questionnaires
- subjects who have been on stable doses of anxiety and/or depression medications (defined as no dose adjustment in the prior 12 weeks) at the screening visit who meet the criteria for anxiety and/or depression based on screening questionnaires and are willing to stay on the same dose of these medications throughout the study duration
- may meet the criteria for both anxiety and depression and cohort assignment will be based on the survey with the highest scores suggesting more severe symptoms
Exclusion
- declines to participate for the full duration of the study
- evidence of active intestinal inflammation based on an elevated c-reactive protein and/or fecal calprotectin, imaging studies or endoscopy
- non-English speaker
- any subject who expresses suicidal ideation or has severe mental illness as they will be taken to the emergency room for urgent psychiatric care
Key Trial Info
Start Date :
July 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT05377840
Start Date
July 5 2022
End Date
December 1 2025
Last Update
February 17 2025
Active Locations (1)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520