RecruitingNot ApplicableNCT06512597

Behavioral Therapy for Crohn's Disease

Combination Therapy of Resilience Intervention With Biologics in Crohn's Disease (CATHARSIS Trial)


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

170 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

People living with Crohn's disease (CD) experience psychological and emotional symptoms, in addition to known chronic and disabling physical symptoms, which prevent them from living their life to the fullest (flourishing). Depression and anxiety are experienced by 30% of people living with CD and 60% of inflammatory bowel disease (IBD) patients continue to report chronic pain, stress, sleeplessness, and fatigue, even when they are "objectively" in remission. Psychological stress has been endorsed by 70% of patients with IBD as a key trigger for disease activity which is not surprising given the significance of the gut-brain-microbiome axis, the close communication between the enteric and autonomic nervous systems, and the role of the hypothalamic-pituitary axis and its neuroendocrine and immune functions in the expression of GI symptoms. Interestingly, up to 85% of patients with CD also endorse the positive impact of effective coping skills on disease course. The PI's prior work has suggested that early provision of effective coping strategies, offered at the time of diagnosis or more precisely, immediately prior to biologic medication initiation, could potentially result in faster healing and improved well-being, likely through the combination of 1) physiological mitigation of the stress response and optimization of the gut-brain-microbiome axis; and 2) promotion of effective coping and disease self-management behaviors that promote psychological flourishing despite disease. Unfortunately, to date, early effective psychosocial care has been limited by concerns over reimbursement for psychological services, access to qualified IBD mental health professionals, and the lack of a standardized methodology focused on the brain-gut stress response and how to assess, monitor, communicate and maintain tight control over both physical and emotional well-being. CATHARSIS is a rigorous, placebo-controlled, randomized controlled trial of coping strategies plus medication for 170 people living with Crohn's for less than 5 years who are about to start a new biologic medication due to active disease. Outcomes include improvements in emotional well-being as well as clinical and endoscopic remission over a 12-month period. The overall goal of the study is to demonstrate that it is essential to combine biologic therapy and psychosocial care to ensure optimal and long-term positive outcomes in CD.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a structured behavioral therapy program (cognitive-behavioral or gut-directed hypnotherapy) to standard biologic medication can help people with active Crohn's disease achieve better control of their symptoms and reduce inflammation. **You may be eligible if...** - You are between 18 and 65 years old and have a confirmed Crohn's disease diagnosis - You have active Crohn's symptoms (CDAI score of at least 220) - You have confirmed active inflammation (on colonoscopy, imaging, or through lab markers) - You are planning to start or recently started a biologic medication (anti-TNF or anti-IL-23) - You live in one of 30+ US states covered by the PSYPACT telehealth agreement **You may NOT be eligible if...** - Your Crohn's disease is currently inactive based on colonoscopy - You are pregnant or planning to become pregnant in the next 12 months - You have severe psychiatric symptoms that would interfere with therapy - You are unable to consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALPrimary Intervention for Combination Therapy - IBD Coping Strategies Program

psychosocially credible treatments each comprised of seven 45-minute sessions over a 12-week period, delivered via telemedicine.

BEHAVIORALTime and Attention Control - IBD Support Program

psychosocially credible treatments each comprised of seven 45-minute sessions over a 12-week period, delivered via telemedicine.


Locations(2)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

New York Gastroenterology Associates

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06512597


Related Trials