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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)
RECRUITINGN/ASponsored by Yale University
Actively Recruiting
PhaseN/A
SponsorYale University
Started2022-07-05
Est. completion2025-12
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT05377840
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: * 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 Criteria: * 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
Conditions4
AnxietyCrohn DiseaseDepressionUlcerative Colitis (UC)
Locations1 site
Yale New Haven Hospital
New Haven, Connecticut, 06520
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Actively Recruiting
PhaseN/A
SponsorYale University
Started2022-07-05
Est. completion2025-12
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT05377840