Back to search results

Behavioral Therapy for Crohn's Disease

This study is looking at how behavioral therapies can help people with Crohn's disease (CD) manage their symptoms and improve their overall well-being. It's testing two different programs: the "IBD Coping Strategies Program" and the "IBD Support Program." Both programs involve seven 45-minute sessions delivered online over 12 weeks. To join, you need to be an adult between 18 and 65 years old with a confirmed diagnosis of Crohn's disease, active symptoms (CDAI of at least 220), and active inflammation seen during an endoscopy (SES-CD over 6, or 4 for certain cases). The study will measure success by looking at your overall health at week 24 using a tool called the PROMIS Global Health Scale. The current status of this study is unclear.

Study design
This interventional study plans to enroll 170 participants. It compares two different behavioral therapy programs delivered via telemedicine.
What's involved
Participants will take part in seven 45-minute sessions over a 12-week period. Your overall health will be assessed at week 24.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 24 weeks after starting the program to assess their global health.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06512597

Behavioral Therapy for Crohn's Disease

Recruiting
NAAges 18–65InterventionalTreatment
Icahn School of Medicine at Mount Sinai
~170 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Primary Intervention for Combination Therapy - IBD Coping Strategies ProgramTime and Attention Control - IBD Support Program

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The PROMIS Global Health Scale
Measured over at week 24

Conditions

Crohn's Disease

Explore related trials

Crohn Disease

Where it's being run

2 sites across 1 states
New York2

Study leadership

  • Laurie Keefer, PhD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
  • Ryan Ungaro, MD, MS · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Laurie Keefer, PhD
[email protected]
212-824-7770
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
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.

What this trial measures

  • The PROMIS Global Health Scaleat week 24

    Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale A series of person-centered measures that evaluate and monitor physical, mental, and social health in adults and children. 10-item patient-reported questionnaire. standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.