Behavioral Therapy for Crohn's Disease

NCT ID: NCT06512597

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2028-07-30

Brief 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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Primary Intervention for Combination Therapy - IBD Coping Strategies Program

This 7-session protocol is based on Dr. Keefer's validated Project Management for Crohn's disease treatment manual. The program specifically focuses on reducing stress, building resilience, fostering self-confidence and disease acceptance, all of which have been associated with improved adjustment to disease and better self-management outcomes in CD.

Group Type: EXPERIMENTAL

Primary Intervention for Combination Therapy - IBD Coping Strategies Program

Intervention Type: BEHAVIORAL

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

Time and Attention Control Group - IBD Support Program (Standard Therapy)

This 7-session condition will serve as a Time and Attention Control to the Coping Strategies Program. The therapist will follow Dr. Keefer's previously validated control condition manual focused on supportive listening, disease education and self-reflection.

Group Type: SHAM_COMPARATOR

Time and Attention Control - IBD Support Program

Intervention Type: BEHAVIORAL

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

Interventions

Primary 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.

Intervention Type: BEHAVIORAL

Time and Attention Control - IBD Support Program

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adults (18-65 years old) of any sex, gender, and racial/ethnic background with an endoscopically and histologically confirmed CD diagnosis will be eligible.
• Participants must have active CD symptoms as defined by a Crohn's Disease Activity Index (CDAI) of at least 220 and
• Active endoscopic inflammation defined as a Simple Endoscopic Score for CD (SES-CD) > 6 (or ≥4 for isolated ileal disease) on most recent colonoscopy OR active disease on imaging study OR elevated calprotectin/CRP levels
• Must be planning to start an anti-TNF (adalimumab, certolizumab, or infliximab) or anti-IL-23 (risankizumab, guselkumab, mirikizumab) within the prior 2 weeks or in the next 6 weeks.
• Participants will need to live in one of Dr Keefer's 30+ PSYPACT licensed states.

Exclusion Criteria

• Endoscopically inactive Crohn's disease at baseline.
• Unable to consent to participation.
• Pregnant or planning to become pregnant in next 12 months.
• Severe psychiatric symptoms.
• Surgical history for CD.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Laurie Keefer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laurie Keefer, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Ryan Ungaro, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status: RECRUITING

New York Gastroenterology Associates

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Laurie Keefer, PhD

Role: CONTACT

laurie.keefer@mssm.edu

212-824-7770

Candela De Amorrortu

Role: CONTACT

candela.deamorrortu@mssm.edu

(857) 259-7585

Other Identifiers

STUDY-24-00338

Identifier Type: -

Identifier Source: org_study_id