Mind-body-medicine and comprehensive lifestyle-modification in patients with Crohn's disease-Feasibility of a randomized controlled trial under pandemic circumstances

Nina Bauer, Claudia Löffler, Özlem Öznur, Christine Uecker, Thomas Keil, Jost Langhorst, Nina Bauer, Claudia Löffler, Özlem Öznur, Christine Uecker, Thomas Keil, Jost Langhorst

Abstract

Introduction: Mind-body medicine (MBM) focuses on stress reduction and lifestyle changes. The primary objective of this pilot trial was to test study feasibility of a complex integrative MBM program for patients with Crohn's disease (CD), especially in rural regions, and under pandemic conditions.

Methods: Patients were stratified and randomized to the intervention group (IG) or the control group (CG). The intervention included a weekly 6-h session for 10 weeks. The CG (waiting list) received an initial 90-min workshop and started the intervention 9 months later. The primary outcome for study feasibility was recruitment and retention rates, as well as reasons for drop-out. The trial took place in Bamberg, Germany (September 2020 to December 2021).

Results: Totally 700 members of the German Crohn's and Colitis Organization-DCCV-were contacted. A total of 15% (102/700; 95% CI 12-17%) expressed interest to participate. Following screening, 41% (95% CI 32-50) were randomized to IG (n = 22) and CG (n = 20). The patients were on average (±standard deviation) 48 ± 13 years old, 67% were female, and have been suffering from CD for 20 ± 12 years. Patients traveled 71.5 ± 48.7 km (range: 9-227 km) to the intervention with no differences between IG and CG. At the 6-month follow-up, 36/42 (86%, 95% CI 74-95%) participants completed final assessment and 19/22 (86%, 95% CI 70-100%) the intervention. The most important reasons for non-responding were work-related (12/60; 20%) and for or drop-out pandemic-related anxiety (3/6). No patient and staff member became infected with SARS-CoV-2 during the study.

Conclusion: The feasibility of the MBM study was confirmed in terms of predefined recruitment and retention criteria, both despite difficult conditions (including the rural setting) and patients' fears associated with the pandemic. It was crucial to develop appropriate hygiene and safety concepts that enable chronically ill patients to participate in helpful group-based interventions even under pandemic conditions.

Clinical trial registration: ClinicalTrials.gov, identifier: NCT05182645.

Keywords: Crohn's disease; feasibility; inflammatory bowel disease; lifestyle modification; mind-body medicine; pandemic; rural conditions; stress management.

Conflict of interest statement

CL received lecture fees from Celgene GmbH, Roche GmbH, Novartis Pharma GmbH, BMS GmbH & Co. KGaA, Mundipharma GmbH Co. KG, Merck KGaA. JL was a speaker for Repha GmbH, Techlab Inc., Falk Foundation, Takeda, Celegene GmbH and Willmar Schwabe and received research funding from Repha GmbH, Techlab Inc., Falk Foundation and Willmar Schwabe. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The handling editor SS declared a shared affiliation with the author TK at the time of review.

Copyright © 2022 Bauer, Löffler, Öznur, Uecker, Keil and Langhorst.

Figures

Figure 1
Figure 1
Illustration of the study design. TSST, Trier Social Stress Test.
Figure 2
Figure 2
Recruitment success, compliance and feasibility of the intervention. Reasons for non-response and drop-out see Figure 3.
Figure 3
Figure 3
Reasons for study discontinuation. *Completion of the intervention was not part of the initial study protocol.

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