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Search / Trial NCT05377840

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)

Launched by YALE UNIVERSITY · May 11, 2022

Trial Information

Current as of November 10, 2025

Recruiting

Keywords

Anxiety, Depression

ClinConnect Summary

This clinical trial is looking at two different approaches to help people with Crohn's disease who also struggle with anxiety and depression. The study is comparing Cognitive Behavioral Therapy (CBT), which is a type of talk therapy that helps change negative thought patterns, to Sudarshan Kriya Yoga (SKY), a breathing technique that promotes relaxation. Researchers want to see which method is more effective at improving mental health in patients with Crohn's disease.

To participate, individuals must have a confirmed diagnosis of Crohn's disease and be on a steady treatment plan without signs of active inflammation. They also need to show symptoms of anxiety or depression based on specific questionnaires. Participants will continue their current medications for these conditions during the study. It's important to note that people with severe mental health issues or active intestinal inflammation will not be eligible to join. If you or someone you know is considering this study, it could be a valuable opportunity to improve mental well-being while managing Crohn's disease.

Gender

ALL

Eligibility 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

About Yale University

Yale University, a prestigious Ivy League institution located in New Haven, Connecticut, is renowned for its commitment to advancing medical research and clinical innovation. With a rich history of academic excellence and a robust infrastructure for scientific inquiry, Yale serves as a leading sponsor for clinical trials aimed at improving patient care and developing new therapeutic approaches. The university's multidisciplinary teams of researchers and clinicians collaborate to conduct rigorous and ethical studies, leveraging cutting-edge technologies and methodologies to address critical health challenges. Through its dedication to fostering an environment of inquiry and discovery, Yale University plays a pivotal role in translating research findings into clinical practice, ultimately enhancing health outcomes for diverse populations.

Locations

New Haven, Connecticut, United States

New Haven, Connecticut, United States

Patients applied

0 patients applied

Trial Officials

Jill Gaidos, MD, FACG

Principal Investigator

Yale University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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