Behavioral therapy to help manage Crohn's disease symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on the psychological and emotional challenges faced by individuals with Crohn's disease, aiming to improve their quality of life through a combination therapy approach. Participants will engage in an IBD Coping Strategies Program alongside a Time and Attention Control IBD Support Program. The study targets adults aged 18-65 with active Crohn's disease symptoms and requires participants to be planning to start anti-TNF therapy. The goal is to assess the impact of behavioral therapy on both psychological well-being and disease activity.

Why it matters

Who can join: the full rules

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 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 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.

Where it's running

• Icahn School of Medicine at Mount Sinai
  New York, New York, United States Recruiting
• New York Gastroenterology Associates
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Laurie Keefer, PhD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Laurie Keefer, PhD
• Email: laurie.keefer@mssm.edu
• Phone: 212-824-7770

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.