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Cognitive Behavioral Therapy vs. Sudarshan Kriya Yoga for Depression in IBD
N/A
Recruiting
Led By Jill Gaidos, MD, FACG
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Verified Crohn's disease
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 6, week 12, week 24 and week 52
Awards & highlights
Study Summary
This trial will compare the effects of CBT versus SKY on anxiety and depression in people with IBD.
Who is the study for?
This trial is for individuals with Crohn's disease who are stable on anxiety or depression meds, without dose changes in the last 12 weeks. They should not have active intestinal inflammation and must commit to the full study duration. Non-English speakers, those with severe mental illness, or active inflammation are excluded.Check my eligibility
What is being tested?
The study aims to see if Cognitive Behavioral Therapy (CBT) or Sudarshan Kriya Yoga (SKY) can improve anxiety and depression in people with Inflammatory Bowel Disease (IBD). Participants will be randomly assigned to either CBT or SKY treatment groups.See study design
What are the potential side effects?
While CBT typically does not cause physical side effects, it may bring up uncomfortable emotions. SKY might lead to mild discomfort like headache or fatigue during initial practice but generally has minimal risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Crohn's disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 6, week 12, week 24 and week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 6, week 12, week 24 and week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in anxiety scores using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire
Mental Depression
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Sudarshan Kriya YogaExperimental Treatment1 Intervention
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
Group II: Cognitive Behavioral TherapyActive Control1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sudarshan Kriya Yoga
2019
Completed Phase 2
~330
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,289 Total Patients Enrolled
Crohn's & Colitis Foundation of America (CCFA)UNKNOWN
Jill Gaidos, MD, FACGPrincipal InvestigatorYale University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not willing to participate in the study for its full duration.I have been diagnosed with Crohn's disease.I may have both anxiety and depression, with one being more severe.I have Crohn's with no current inflammation and anxiety or depression.I have signs of active gut inflammation.I have been on a stable dose of medication for anxiety or depression for the last 12 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitive Behavioral Therapy
- Group 2: Sudarshan Kriya Yoga
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical experiment currently have any openings for volunteers?
"Affirmative. The clinicaltrials.gov portal verifies that this medical trial, which was initiated on July 5th 2022, is presently recruiting participants. 152 individuals need to be sourced from 1 different medical centre."
Answered by AI
What is the present size of the patient cohort in this investigation?
"Affirmative. According to the information posted on clinicaltrials.gov, this medical trial is currently enrolling patients. The study was first published on July 5th 2022 and its details were recently updated on July 11th 2022; 152 participants are needed at one location."
Answered by AI
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