ClinicalTrials.gov
Cure8 trial brief
Behavioral Therapy for Crohn's Disease
Research and clinical trials
Microbiome
Depression
Anxiety
Fatigue
Pain
Phase 2 clinical trial
Adult patients
Why This Matters
The study tests whether combining a standardized coping-skills program with biologic therapy improves emotional well-being and clinical/endoscopic outcomes in people with early Crohn's disease—addressing common mental-health burdens that patients report as important triggers and modifiers of disease.
Who Should Pay Attention
Adults with recent Crohn's diagnosis, people about to start biologic therapy, IBD clinicians, and researchers interested in gut-brain and psychosocial interventions.
Study Snapshot
Story typeClinical Reference
Trial phaseNA
Enrollment170 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
This is a randomized, placebo-controlled (time-and-attention control), interventional trial called CATHARSIS enrolling adults with Crohn's disease of under 5 years' duration who are about to start a new biologic.
The psychosocial intervention is a seven-session IBD Coping Strategies Program delivered via telemedicine; the control arm receives a matched-support program. The study plans to enroll 170 participants and measures patient-reported global health at 24 weeks plus clinical and endoscopic outcomes over 12 months.
The behavioral program is based on a validated Project Management for Crohn's Disease manual and targets stress reduction, resilience, and disease self-management. Eligible participants must be initiating an anti-TNF (adalimumab, certolizumab, infliximab) or an anti–IL-23 (risankizumab, guselkumab, mirikizumab) and have objective evidence of active disease.
Keep In Mind
This is a registered interventional trial (recruiting) and does not present findings. The psychosocial intervention is delivered via telemedicine and enrollment requires initiation of specified biologics and objective evidence of active disease.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorIcahn School of Medicine at Mount Sinai
Trial IDNCT06512597
Study typeInterventional
Trial phaseNA
Enrollment170 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 12, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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