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Behavioral Intervention

Behavioral Therapy for Crohn's Disease

N/A

Recruiting

Led By Ryan Ungaro, MD, MS

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have active CD symptoms as defined by a Crohn's Disease Activity Index (CDAI) of at least 220

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

Must not have

Endoscopically inactive Crohn's disease at baseline

Unable to consent to participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at weeks 12, 24, 36 and 52

Summary

"This trial aims to study the impact of combining coping strategies with medication on the well-being of people with Crohn's disease. Many patients with Crohn's experience psychological distress, even when their physical symptoms

Who is the study for?

This trial is for people who have been living with Crohn's disease for less than 5 years and are about to begin a new biologic medication due to active disease. It aims to help them cope better emotionally and physically.

What is being tested?

The study tests if combining coping strategies from the IBD Coping Strategies Program with biologic medications can improve emotional well-being and lead to clinical remission in Crohn's patients, compared to just offering support through the IBD Support Program.

What are the potential side effects?

While specific side effects are not detailed here, behavioral therapy may include temporary increases in distress as individuals confront difficult emotions or situations during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My Crohn's disease is currently active.

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My recent colonoscopy shows significant inflammation in my intestines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My Crohn's disease is not active according to my last endoscopy.

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I am unable to give consent for participation on my own.

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I have had surgery for Crohn's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at weeks 12, 24, 36 and 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at weeks 12, 24, 36 and 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and at weeks 12, 24, 36 and 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The PROMIS Global Health Scale

Secondary study objectives

C-reactive protein level

Crohn's Disease Activity Index (CDAI)

Inflammatory Bowel Disease Questionnaire (IBDQ)

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Primary Intervention for Combination Therapy - IBD Coping Strategies ProgramExperimental Treatment1 Intervention

This 7-session protocol is based on Dr. Keefer's validated Project Management for Crohn's disease treatment manual. The program specifically focuses on reducing stress, building resilience, fostering self-confidence and disease acceptance, all of which have been associated with improved adjustment to disease and better self-management outcomes in CD.

Group II: Time and Attention Control Group - IBD Support Program (Standard Therapy)Placebo Group1 Intervention

This 7-session condition will serve as a Time and Attention Control to the Coping Strategies Program. The therapist will follow Dr. Keefer's previously validated control condition manual focused on supportive listening, disease education and self-reflection.

0 / 5Eligibility criteria met