Evaluation of a multimodal stress management and comprehensive lifestyle modification program on quality-of-life and gastrointestinal symptoms in patients with Crohn's Disease - A randomized controlled pilot trial with nine-month follow-up.

Abstract

Stress and lifestyle factors impact the course of Crohn's Disease (CD). Our primary objective was to assess whether patients with CD benefit from a mind-body-medicine stress management and lifestyle modification (MBM) program. This 9-month two-arm pilot trial was conducted in Bamberg, Germany (2020-2021). Patients (18-75 years) with mild to moderate activity of CD and stable medication were enrolled and randomly assigned to either a 10-week MBM program (intervention group, IG) or a single 90-minutes education session (waiting list control group, CG). Primary endpoints were quality of life (IBDQ) and disease activity (HBI). Secondary endpoints were emotional distress, core self-evaluation, and inflammatory biomarkers 3 and 9 months after baseline assessment. We analysed data from thirty-seven patients (IG: n=19, mean±SD age 49.6±13.1 years, 68% female; CG: 18, 46.8±11.4, 67% female). Immediately after the intervention, 79% (IG) and 44% (CG) experienced a clinically relevant improvement (IBDQ score ≥16 points). This was similar after 9 months (63% vs 44%). There was no difference in disease activity (3 months: p=.082, 95%CI -1.3-2.6; 9 months: p=.251, 95%CI -1.2-2.5). Secondary outcomes indicated improvements in emotional distress, core self-evaluation, erythrocyte sedimentation rate after three and in emotional distress, T-cell-profiling in the blood, and fecal lactoferrin and calprotectin group after 9 months in the intervention group. Our study suggested benefits of a multimodal stress management and lifestyle modification program for patients with CD. Larger trials are needed to determine if the program can supplement or at least partially replace pharmacological treatment approaches. gov ID: NCT05182645.