What side effects are associated with this type of intervention?

Common pharmacological treatments for Crohn's Disease include glucocorticoids, which can cause side effects such as weight gain, osteoporosis, and increased risk of infections. Thiopurines may lead to bone marrow suppression and liver toxicity. Biologic therapies, like TNF inhibitors, can increase the risk of infections and may cause injection site reactions. Non-pharmacological treatments like Cognitive Behavioral Therapy (CBT) and Sudarshan Kriya Yoga (SKY) focus on reducing stress and improving mental health. These therapies generally have minimal side effects, with CBT potentially causing temporary emotional discomfort as patients confront challenging thoughts, and SKY being well-tolerated with rare reports of dizziness or lightheadedness during breathing exercises.

What prior FDA approvals exist?

FDA-approved treatments for Crohn's Disease primarily include pharmacological options such as aminosalicylates, corticosteroids, immunomodulators, and biologics like TNF inhibitors (e.g., infliximab, adalimumab). While these drugs target inflammation and immune response, non-pharmacological approaches like Cognitive Behavioral Therapy (CBT) and Sudarshan Kriya Yoga (SKY) are being studied for their potential to alleviate stress and anxiety, which can indirectly benefit Crohn's patients by improving overall well-being and potentially reducing symptom severity.

What other types of research exist?

Promising novel alternatives for Crohn's Disease patients include gut-directed hypnotherapy, which has shown efficacy similar to the low FODMAP diet for irritable bowel syndrome, and osteopathy, which has been found to decrease the severity of IBS-like symptoms associated with Crohn's Disease in patients in remission.

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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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 6, week 12, week 24 and week 52

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if talk therapy (CBT) or yoga breathing exercises (SKY) can help reduce anxiety and depression in people with Crohn's disease. The study will compare the effects of these treatments on mental health, quality of life, pain, and fatigue. Yoga has several mechanisms that make it a promising treatment for depression and anxiety, including physical activity, behavioural activation, and mindfulness.

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.

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.

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 below

Select...

I have been diagnosed with Crohn's disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not willing to participate in the study for its full duration.

Select...

I have signs of active gut inflammation.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 6, week 12, week 24 and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in anxiety scores using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire

Mental Depression

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Crohn's Disease include anti-inflammatory drugs, immune system suppressors, antibiotics, and biologics. Anti-inflammatory drugs reduce inflammation in the gastrointestinal tract, while immune system suppressors target the immune response that causes inflammation. Antibiotics can treat or prevent infections that may trigger symptoms, and biologics block specific proteins involved in the inflammatory process. For Crohn's Disease patients, these treatments are crucial as they help manage symptoms, reduce flare-ups, and maintain remission. Similarly, Cognitive Behavioral Therapy (CBT) and Sudarshan Kriya Yoga (SKY) can be beneficial by addressing the psychological and stress-related components of the disease, potentially reducing symptom severity and improving overall quality of life.

The Effect of Breathing, Movement, and Meditation on Psychological and Physical Symptoms and Inflammatory Biomarkers in Inflammatory Bowel Disease: A Randomized Controlled Trial.