Behavioral Therapy for Crohn's Disease

Mount Sinai Health System

Status: Enrolling

Conditions: Crohn's Disease

Treatments: Behavioral: Time and Attention Control - IBD Support Program; Behavioral: Primary Intervention for Combination Therapy - IBD Coping Strategies Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06512597

STUDY-24-00338

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 a colonoscopy within the prior 8 weeks. This is in line with Food and Drug Administration (FDA) guidance for CD clinical trial populations.
• Participants must be planning to start an anti-TNF (adalimumab, certolizumab, or infliximab) 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 2 patient groups

Primary Intervention for Combination Therapy - IBD Coping Strategies Program

Experimental group

Description:

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.

Treatment:

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

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

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Time and Attention Control - IBD Support Program