Use of Cognitive Behavioral Therapy (CBT) or Sudarshan Kriya Yoga (SKY) for the Treatment of Anxiety and/or Depression in Inflammatory Bowel Disease (IBD)
Primary Purpose
Crohn Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sudarshan Kriya Yoga
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease focused on measuring anxiety, depression
Eligibility Criteria
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
Sites / Locations
- Yale New Haven HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Cognitive Behavioral Therapy
Sudarshan Kriya Yoga
Arm Description
Participants in this arm will participate in CBT to assess the impact it will have on anxiety or depression among patients with Crohn's disease
Participants in this arm will participate in SKY to assess the impact it will have on anxiety or depression among patients with Crohn's disease
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05377840
First Posted
May 11, 2022
Last Updated
June 26, 2023
Sponsor
Yale University
Collaborators
Crohn's & Colitis Foundation of America (CCFA)
1. Study Identification
Unique Protocol Identification Number
NCT05377840
Brief Title
Use of Cognitive Behavioral Therapy (CBT) or Sudarshan Kriya Yoga (SKY) for the Treatment of Anxiety and/or Depression in Inflammatory Bowel Disease (IBD)
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Crohn's & Colitis Foundation of America (CCFA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
anxiety, depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In this prospective, single center, randomized treatment study, participants will be screening for anxiety and depression in a Crohn's disease population using the Generalized Anxiety Disorder (GAD) questionnaire and the Patient Health Questionnaire (PHQ). Subjects 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 subjects 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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Description
Participants in this arm will participate in CBT to assess the impact it will have on anxiety or depression among patients with Crohn's disease
Arm Title
Sudarshan Kriya Yoga
Arm Type
Experimental
Arm Description
Participants in this arm will participate in SKY to assess the impact it will have on anxiety or depression among patients with Crohn's disease
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sudarshan Kriya Yoga
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in anxiety scores using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire
Description
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.
Time Frame
baseline, week 6, week 12, week 24 and week 52
Title
Change from baseline in depression scores using the Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
baseline, week 6, week 12, week 24, and week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Gaidos, MD, FACG
Phone
203-785-4138
Email
jill.gaidos@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Gaidos, MD, FACG
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Use of Cognitive Behavioral Therapy (CBT) or Sudarshan Kriya Yoga (SKY) for the Treatment of Anxiety and/or Depression in Inflammatory Bowel Disease (IBD)
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