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Behavioral Therapy for Crohn's Disease

Combination Therapy of Resilience Intervention With Biologics in Crohn's Disease (CATHARSIS Trial)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Travel or expenses covered

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Travel or expenses covered
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether coping skills therapy plus medicine can improve emotional well-being and help control Crohn's disease, which causes swelling in the digestive tract. It is for adults who have had Crohn's for less than 5 years, have active disease, and are starting a new biologic medicine. The study will track results for 12 months.

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, even when they are "objectively" in remission. Psychological stress has been endorsed by 70% of patients with IBD as a key trigger for disease activity which is not surprising given the significance of the gut-brain-microbiome axis, the close communication between the enteric and autonomic nervous systems, and the role of the hypothalamic-pituitary axis and its neuroendocrine and immune functions in the expression of GI symptoms. Interestingly, up to 85% of patients with CD also endorse the positive impact of effective coping skills on disease course. The PI's prior work has suggested that early provision of effective coping strategies, offered at the time of diagnosis or more precisely, immediately prior to biologic medication initiation, could potentially result in faster healing and improved well-being, likely through the combination of 1) physiological mitigation of the stress response and optimization of the gut-brain-microbiome axis; and 2) promotion of effective coping and disease self-management behaviors that promote psychological flourishing despite disease. Unfortunately, to date, early effective psychosocial care has been limited by concerns over reimbursement for psychological services, access to qualified IBD mental health professionals, and the lack of a standardized methodology focused on the brain-gut stress response and how to assess, monitor, communicate and maintain tight control over both physical and emotional well-being. CATHARSIS is a rigorous, placebo-controlled, randomized controlled trial of coping strategies plus medication for 170 people living with Crohn's for less than 5 years who are about to start a new biologic medication due to active disease. Outcomes include improvements in emotional well-being as well as clinical and endoscopic remission over a 12-month period. The overall goal of the study is to demonstrate that it is essential to combine biologic therapy and psychosocial care to ensure optimal and long-term positive outcomes in CD.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18–65, of any sex, gender, race, or ethnic background.
  • Crohn's disease confirmed by a scope exam and tissue samples.
  • Active Crohn's symptoms, with a Crohn's Disease Activity Index score of at least 220.
  • Signs of active disease on a colonoscopy or imaging test, or high stool calprotectin or blood CRP levels, which are signs of swelling. The colonoscopy score must be above 6, or at least 4 if only the last part of the small intestine is affected.
  • Started or plan to start one of these medicines within the past 2 weeks or next 6 weeks: adalimumab, certolizumab, infliximab, risankizumab, guselkumab, or mirikizumab.
  • Live in one of the more than 30 PSYPACT states where Dr. Keefer is licensed to provide care.

Who can't join

  • Crohn's disease is not active on a scope exam at the start of the study.
  • Unable to give consent to join the study.
  • Pregnant or planning to become pregnant in the next 12 months.
  • Severe mental health symptoms.
  • Past surgery for Crohn's disease.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (2)

NY