克罗恩病患者的身心医学与综合生活方式改变——大流行情况下随机对照试验的可行性

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

作者信息

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

机构信息

Department of Internal and Integrative Medicine, Sozialstiftung Bamberg, Bamberg, Germany.

Department of Integrative Medicine, Medical Faculty, University of Duisburg-Essen, Bamberg, Germany.

出版信息

Front Integr Neurosci. 2022 Aug 23;16:960301. doi: 10.3389/fnint.2022.960301. eCollection 2022.

DOI:10.3389/fnint.2022.960301

PMID:36081609

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9447476/

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 ( = 22) and CG ( = 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.

摘要

引言

身心医学（MBM）专注于减轻压力和改变生活方式。这项试点试验的主要目的是测试一项针对克罗恩病（CD）患者的复杂综合MBM计划的研究可行性，特别是在农村地区以及疫情条件下。

方法

患者被分层并随机分为干预组（IG）或对照组（CG）。干预包括每周一次为期6小时的课程，共10周。对照组（等候名单）参加了一次为期90分钟的初始研讨会，并在9个月后开始干预。研究可行性的主要结果是招募率和留存率，以及退出原因。该试验在德国班贝格进行（2020年9月至2021年12月）。

结果

总共联系了德国克罗恩病和结肠炎组织-DCCV的700名成员。共有15%（102/700；95%置信区间12-17%）表示有兴趣参与。经过筛选，41%（95%置信区间32-50）被随机分配到IG组（n = 22）和CG组（n = 20）。患者平均（±标准差）年龄为48±13岁，67%为女性，患有CD达20±12年。患者前往干预地点的行程为71.5±48.7公里（范围：9-227公里），IG组和CG组之间无差异。在6个月的随访中，36/42（86%，95%置信区间74-95%）的参与者完成了最终评估，19/22（86%，95%置信区间70-100%）完成了干预。无应答的最重要原因是与工作相关（12/60；20%），退出的原因是与疫情相关的焦虑（3/6）。在研究期间，没有患者和工作人员感染SARS-CoV-2。