Behavioral Therapy for Crohn's Disease

NCT06512597 | Recruiting DMC

• 1 other identifier: STUDY-24-00338
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• The PROMIS Global Health Scale

  Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale A series of person-centered measures that evaluate and monitor physical, mental, and social health in adults and children. 10-item patient-reported questionnaire. standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.

  at week 24

Secondary Outcomes (10)

• Psychological Well-Being Scale

  at weeks 12, 24, 36 and 52

• Inflammatory Bowel Disease Self-Efficacy Scale (IBD-SES)

  at weeks 12, 24, 36 and 52

• NIH PROMIS-29

  at weeks 12, 24, 36 and 52

• Crohn's Disease Activity Index (CDAI)

  at weeks 12, 36, and 52

• Patient-Reported Outcomes (PRO2)

  at weeks 12, 24, 36, and 52

Study Arms (2)

Primary Intervention for Combination Therapy - IBD Coping Strategies Program

EXPERIMENTAL

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.

Behavioral: Primary Intervention for Combination Therapy - IBD Coping Strategies Program

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

SHAM COMPARATOR

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.

Behavioral: Time and Attention Control - IBD Support Program

Interventions

Primary Intervention for Combination Therapy - IBD Coping Strategies Program BEHAVIORAL

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

Primary Intervention for Combination Therapy - IBD Coping Strategies Program

Time and Attention Control - IBD Support Program 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)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (2)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

New York Gastroenterology Associates

New York, New York, 10128, United States

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Time

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Laurie Keefer, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Ryan Ungaro, MD, MS

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurie Keefer, PhD

CONTACT

212-824-7770; laurie.keefer@mssm.edu

Candela De Amorrortu

CONTACT

(857) 259-7585; candela.deamorrortu@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 22, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2028
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)