Status:
RECRUITING
Behavioral Therapy for Crohn's Disease
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
The Leona M. and Harry B. Helmsley Charitable Trust
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2028
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06512597
Start Date
November 1 2024
End Date
July 30 2028
Last Update
November 20 2025
Active Locations (2)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
2
New York Gastroenterology Associates
New York, New York, United States, 10128