COMBINATION THERAPY OF RESILIENCE INTERVENTION WITH BIOLOGICS IN CROHN’S DISEASE (CATHARSIS) IS MET WITH EARLY ACCEPTABILITY AND HIGH EXPECTANCY

Abstract BACKGROUND Novel treatment approaches are needed to raise the therapeutic ceiling in Crohn’s disease (CD). Increasing evidence suggests that behavioral interventions targeting the gut-brain axis and psychological resilience may optimize clinical outcomes. Thus, we are testing the efficacy of a novel combination therapy pairing behavioral and biologic treatments in a rigorous, prospective, randomized controlled trial (CATHARSIS: Combination Therapy of Resilience Intervention with Biologics in Crohn’s Disease NCT06512597; funding by Helmsley). Feasibility and early outcomes from the trial’s first year are reported below. METHODS Adults with moderate-to-severe CD commencing anti-TNF or anti-IL-23 medications are currently being recruited. Exclusion criteria include recent or upcoming surgery, ostomy and severe psychopathology. Participants are randomized 1:1 to receive either active intervention (biologic + structured brain gut behavioral therapy) or attention control (biologic + general support). Both programs are time-limited (7 sessions, 12 weeks) and therapist-delivered; participants are blinded to allocation. Outcomes include global wellbeing, clinical remission and various measures of psychological and physical health. An expectancy questionnaire was completed after session 1. RESULTS To date, 41 participants have been enrolled (38% of those eligible; see Image 1). Current sample (see Image 2): age range 19 to 76 years, 51% female, 78% white. Participants’ mean disease duration was 8.9 years (SD=11.1), and disease activity on average fell within the moderate range (PRO2, M=30.3, SD=27.0). Half of the participants were bio-naive; 15 (37%) started on anti-TNF and 26 (63%) on anti-IL-23 agents. There were no significant differences between groups on baseline variables. Participants in both conditions held positive expectations that the behavioral programs will improve CD symptoms and/or quality of life: mean expectancy ratings (out of 9) were 7.4 (SD=1.5) for how logical the intervention seemed, 6.1 (SD=1.5) for likely treatment success, and 6.6 (SD=2.0) for confidence in recommending the program to others. On average, participants predicted a 60% improvement at 12 weeks, regardless of treatment condition. Program satisfaction was high (M=28.7, SD=3.8; range 8-32) and similar between groups. So far, 31 participants have completed treatment, with zero drop-out. CONCLUSIONS Early data support the rigor and quality of the CATHARSIS trial. Recruitment has been feasible and well accepted. Randomization has achieved groups similar on baseline socio-demographic and clinical characteristics. Both programs have yielded high expectancy and satisfaction ratings, indicating successful masking to hypothesis. Full retention reflects strong engagement and acceptance of behavioral therapy in CD care. Continuation of the trial is therefore warranted.