Use of Cognitive Behavioral Therapy (CBT) or Sudarshan Kriya Yoga (SKY) for the Treatment of Anxiety and/or Depression in Inflammatory Bowel Disease (IBD)

Crohn Disease Clinical Trial

Official title: Effect of Cognitive Behavioral Therapy or Sudarshan Kriya Yoga Breath Meditation in the Treatment of Anxiety and Depression in Patients With Inflammatory Bowel Disease

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This is a prospective, single center, randomized treatment study, where participants will be screened for anxiety and depression in a Crohn's disease population using the Generalized Anxiety Disorder (GAD) questionnaire and the Patient Health Questionnaire (PHQ). Participants with GAD scores of ≥8 will be considered to have anxiety and those with a PHQ score of ≥10 will be considered to have depression. All participants with screening questionnaire scores positive for anxiety or depression will be randomized to treatment with either cognitive behavioral therapy (CBT) or Sudarshan Kriya Yoga (SKY). Screening with GAD and PHQ will be repeated post treatment at weeks 6, 12 and 24. The primary objective of this study is to assess for an improvement in GAD and PHQ scores among subjects treated with CBT compared to those treated with SKY. The secondary objectives are to assess for improvements in health-related quality of life, based on short IBD Questionnaire scores; assess for improvement in pain scores, based on the Brief Pain Inventory Short Form; and assess for improvement in fatigue scores based on the FACIT-Fatigue Scale, among subjects with poor scores at baseline following treatment with CBT or SKY. ;

Related Conditions & MeSH terms

• Crohn Disease
• Depression
• Inflammatory Bowel Diseases

• NCT number: NCT05377840
• Study type: Interventional
• Source: Yale University
• Contact: Jill Gaidos, MD, FACG
• Phone: 203-785-4138
• Email: jill.gaidos@yale.edu
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2022
• Completion date: December 2024