Behavioral Therapy for Crohn's Disease

Official title

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

Overview

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.

Interventions

• Behavioral Primary Intervention for Combination Therapy - IBD Coping Strategies Program
  psychosocially credible treatments each comprised of seven 45-minute sessions over a 12-week period, delivered via telemedicine.
• Behavioral Time and Attention Control - IBD Support Program
  psychosocially credible treatments each comprised of seven 45-minute sessions over a 12-week period, delivered via telemedicine.

Primary outcome measures

• The PROMIS Global Health Scale [Time frame: at week 24]

Secondary outcome measures (10)

• Psychological Well-Being Scale [Time frame: at weeks 12, 24, 36 and 52]
• Inflammatory Bowel Disease Self-Efficacy Scale (IBD-SES) [Time frame: at weeks 12, 24, 36 and 52]
• NIH PROMIS-29 [Time frame: at weeks 12, 24, 36 and 52]
• Crohn's Disease Activity Index (CDAI) [Time frame: at weeks 12, 36, and 52]
• Patient-Reported Outcomes (PRO2) [Time frame: at weeks 12, 24, 36, and 52]
• Inflammatory Bowel Disease Questionnaire (IBDQ) [Time frame: at weeks 12, 24, 36, and 52]
• UCLA GI Symptom Severity Score [Time frame: at weeks 12, 24, 36, and 52]
• Simple Endoscopic Score for Crohn's Disease (SES-CD) [Time frame: at 24 weeks]
• C-reactive protein level [Time frame: up to 24 weeks]
• fecal calprotectin level [Time frame: up to 24 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 2 centers

• Icahn School of Medicine at Mount Sinai — New York
• New York Gastroenterology Associates — New York

Identifiers

NCT: NCT06512597 · STUDY-24-00338

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗