Behavioral Therapy for Crohn's Disease
Not applicable · Testing Primary Intervention for Combination Therapy - IBD Coping Strategies Program and Time and… · 2 sites · Icahn School of Medicine at Mount Sinai
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Primary Intervention for Combination Therapy - IBD Coping Strategies Program (a behavioral program) and Time and Attention Control - IBD Support Program (a behavioral program) as a possible treatment. Condition(s) listed: Crohn's Disease.
Participants are assigned to groups by chance (randomized).
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 65
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 2 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 170 participants are expected to take part.
- Start date: 2024-11-01.
- Main results expected around 2027-07-30 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in United States.
Main thing being measured
- The PROMIS Global Health Scale (at week 24)
In the researchers’ words
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 fullest (flourishing). Depression and anxiety are experienced by 30% of people living with CD and 60% of inflammatory bowel disease (IBD) patients continue to report chronic pain, stress, sleeplessness, and fatigue,…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn's Disease |
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
| Collaborators | The Leona M. and Harry B. Helmsley Charitable Trust |
| Enrollment | 170 (estimated) |
| Start date | 2024-11-01 |
| Primary completion (est.) | 2027-07-30 |
| First posted | 2024-07-22 |
| Last updated | 2026-08-12 |
| Official title | Combination Therapy of Resilience Intervention With Biologics in Crohn's Disease (CATHARSIS Trial) |
| ClinicalTrials.gov ID | NCT06512597 |
Interventions
- Primary Intervention for Combination Therapy - IBD Coping Strategies Program (Behavioral)
psychosocially credible treatments each comprised of seven 45-minute sessions over a 12-week period, delivered via telemedicine. - Time and Attention Control - IBD Support Program (Behavioral)
psychosocially credible treatments each comprised of seven 45-minute sessions over a 12-week period, delivered via telemedicine.
Full eligibility criteria (from the record)
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.
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| 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 |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.