Behavioral therapy to help manage Crohn's disease symptoms
Combination Therapy of Resilience Intervention With Biologics in Crohn's Disease (CATHARSIS Trial)
This study is testing whether a combination of behavioral therapy and support programs can help adults with active Crohn's disease feel better both mentally and physically while they start a new medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Drugs / interventions | adalimumab, certolizumab, infliximab, risankizumab, guselkumab, mirikizumab |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT06512597 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with an endoscopically and histologically confirmed diagnosis of active Crohn's disease.
Not a fit: Patients with endoscopically inactive Crohn's disease or severe psychiatric symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the quality of life for patients with Crohn's disease by addressing both psychological and physical symptoms.
How similar studies have performed: Previous studies have indicated that psychological interventions can positively influence disease outcomes in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New York, New York and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.