Cognitive Behavioral Therapy for Anxiety and Depression in IBD Patients
Effect Cognitive Behavioral Therapy (CBT) in the Treatment of Anxiety and Depression in Patients With Inflammatory Bowel Disease
This study is testing whether getting cognitive behavioral therapy from a psychologist works better than doing it on your own for helping people with anxiety and depression who have inflammatory bowel disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05377840 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of psychologist-administered cognitive behavioral therapy (CBT) versus self-administered CBT for treating anxiety and depression in patients with inflammatory bowel disease (IBD), specifically Crohn's disease and ulcerative colitis. Participants will be screened for anxiety and depression using standardized questionnaires and will be randomized to receive either form of CBT. The study aims to measure improvements in anxiety and depression scores, as well as health-related quality of life, pain, and fatigue over a 24-week period. Follow-up assessments will occur at 6, 12, and 24 weeks post-treatment.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Crohn's disease or ulcerative colitis who also exhibit symptoms of anxiety or depression.
Not a fit: Patients with active intestinal inflammation or those unwilling to commit to the study duration may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective therapeutic options for managing anxiety and depression in patients with IBD.
How similar studies have performed: Other studies have shown positive outcomes using CBT for anxiety and depression in chronic illness populations, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New Haven, Connecticut
- Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Jill Gaidos, MD, FACG — Yale University
- Study coordinator: Jill Gaidos, MD, FACG
- Email: jill.gaidos@yale.edu
- Phone: 203-785-4138
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.