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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05377840
• Other study ID #: 2000031323
• Secondary ID: 878888
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2022
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Yale University
• Contact: Jill Gaidos, MD, FACG
• Phone: 203-785-4138
• Email: jill.gaidos[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• verified Crohn's disease
• Crohn's 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

Related Conditions & MeSH terms

• Crohn Disease
• Depression
• Inflammatory Bowel Diseases

Intervention

Behavioral:
• Cognitive Behavioral Therapy
CBT is a combined psycho-social intervention that aims to improve overall mental health focusing on developing coping strategies. standard CBT Participants will have individual weekly sessions lasting 60 minutes each over an 8-week period with 1 follow-up maintenance session at week 12.
• Sudarshan Kriya Yoga
SKY Breath Meditation is a deep breathing and meditation technique that enables physiological changes leading to improved mental and physical health. Participants will first attend a 3-day online workshop (2.5 hours each day) delivered live by a certified instructor to learn the SKY Breath Meditation practice. Participants will then practice SKY 25 minutes daily for 6 weeks and 3-4 times per week up to 12 weeks.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Crohn's & Colitis Foundation of America (CCFA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in anxiety scores using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire	Change from baseline in anxiety using GAD-7 compared to week 6, week 12 and week 24 (post treatment). Generalized Anxiety Disorder-7 questionnaire is a 7-item validated questionnaire used to screen for anxiety with a range of scores from 0-3. A cumulative score of =8 is considered positive for anxiety with lower scores indicating no or mild anxiety.	baseline, week 6, week 12, week 24 and week 52
Primary	Change from baseline in depression scores using the Patient Health Questionnaire-9 (PHQ-9)	Change from baseline in depression using PHQ-9 compared to week 6, week 12 and week 24 (post treatment). PHQ-9 is a 9-item validated questionnaire used to screen for depression with a range of scores from 0-45. A cumulative score of =10 is considered positive with lower scores indicating no or mild anxiety.	baseline, week 6, week 12, week 24, and week 52