Clinical trial NCT06512597: Behavioral Therapy for Crohn's Disease
Official title: Combination Therapy of Resilience Intervention with Biologics in Crohn's Disease (CATHARSIS Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn's Disease
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: The Leona M. and Harry B. Helmsley Charitable Trust
First posted: 2024-07-22
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 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.

Primary outcomes:
measure: The PROMIS Global Health Scale
timeFrame: at week 24
Secondary outcomes:
measure: Psychological Well-Being Scale
timeFrame: at weeks 12, 24, 36 and 52
measure: Inflammatory Bowel Disease Self-Efficacy Scale (IBD-SES)
timeFrame: at weeks 12, 24, 36 and 52
measure: NIH PROMIS-29
timeFrame: at weeks 12, 24, 36 and 52
measure: Crohn's Disease Activity Index (CDAI)
timeFrame: at weeks 12, 36, and 52
measure: Patient-Reported Outcomes (PRO2)
timeFrame: at weeks 12, 24, 36, and 52
measure: Inflammatory Bowel Disease Questionnaire (IBDQ)
timeFrame: at weeks 12, 24, 36, and 52
measure: UCLA GI Symptom Severity Score
timeFrame: at weeks 12, 24, 36, and 52
measure: Simple Endoscopic Score for Crohn's Disease (SES-CD)
timeFrame: at 24 weeks
measure: C-reactive protein level
timeFrame: up to 24 weeks
measure: fecal calprotectin level
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Laurie Keefer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Ryan Ungaro, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: