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COMET研究的研究方案:一项整群随机、前瞻性、平行组、优效性试验,旨在比较协作式逐步照护模式与初级保健中精神障碍患者常规治疗的有效性。

Study protocol for the COMET study: a cluster-randomised, prospective, parallel-group, superiority trial to compare the effectiveness of a collaborative and stepped care model versus treatment as usual in patients with mental disorders in primary care.

作者信息

Heddaeus Daniela, Dirmaier Jörg, Brettschneider Christian, Daubmann Anne, Grochtdreis Thomas, von dem Knesebeck Olaf, König Hans-Helmut, Löwe Bernd, Maehder Kerstin, Porzelt Sarah, Rosenkranz Moritz, Schäfer Ingo, Scherer Martin, Schulte Bernd, Wegscheider Karl, Weigel Angelika, Werner Silke, Zimmermann Thomas, Härter Martin

机构信息

Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

出版信息

BMJ Open. 2019 Nov 24;9(11):e032408. doi: 10.1136/bmjopen-2019-032408.

DOI:10.1136/bmjopen-2019-032408
PMID:31767595
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6887029/
Abstract

INTRODUCTION

Mental healthcare is one of the biggest challenges for healthcare systems. Comorbidities between different mental disorders are common, and patients suffer from a high burden of disease. While the effectiveness of collaborative and stepped care models has been shown for single disorders, comorbid mental disorders have rarely been addressed in such care models. The aim of the present study is to evaluate the effectiveness of a collaborative and stepped care model for depressive, anxiety, somatoform and alcohol use disorders within a multiprofessional network compared with treatment as usual.

METHODS AND ANALYSIS

In a cluster-randomised, prospective, parallel-group superiority trial, n=570 patients will be recruited from primary care practices (n=19 practices per group). The intervention is a newly developed collaborative and stepped care model in which patients will be treated using treatment options of various intensities within an integrated network of outpatient general practitioners, psychiatrists, psychotherapists and inpatient institutions. It will be compared with treatment as usual with regard to effectiveness, cost-effectiveness and feasibility, with the primary outcome being a change in mental health-related quality of life from baseline to 6 months. Patients in both groups will undergo an assessment at baseline, 3, 6 and 12 months after study inclusion.

ETHICS AND DISSEMINATION

The study has been approved by the ethics committee of the Hamburg Medical Association (No. PV5595) and will be carried out in accordance with the principles of the Declaration of Helsinki. For dissemination, the results will be published in peer-reviewed journals and presented at conferences. Within the superordinate research project Hamburg Network for Health Services Research, the results will be communicated to relevant stakeholders in mental healthcare.

TRIAL REGISTRATION NUMBER

NCT03226743.

摘要

引言

精神卫生保健是医疗系统面临的最大挑战之一。不同精神障碍之间的共病情况很常见,患者承受着很高的疾病负担。虽然协作式和阶梯式护理模式对单一障碍的有效性已得到证实,但此类护理模式很少涉及共病精神障碍。本研究的目的是评估在多专业网络中,与常规治疗相比,协作式和阶梯式护理模式对抑郁、焦虑、躯体形式障碍和酒精使用障碍的有效性。

方法与分析

在一项整群随机、前瞻性、平行组优效性试验中,将从基层医疗诊所招募n = 570名患者(每组19个诊所)。干预措施是一种新开发的协作式和阶梯式护理模式,患者将在门诊全科医生、精神科医生、心理治疗师和住院机构的综合网络中,使用不同强度的治疗方案进行治疗。将在有效性、成本效益和可行性方面将其与常规治疗进行比较,主要结局是从基线到6个月时心理健康相关生活质量的变化。两组患者将在纳入研究后的基线、3个月、6个月和12个月接受评估。

伦理与传播

该研究已获得汉堡医学协会伦理委员会的批准(编号PV5595),并将按照《赫尔辛基宣言》的原则进行。为了传播,研究结果将发表在同行评审期刊上,并在会议上展示。在上级研究项目“汉堡卫生服务研究网络”中,研究结果将传达给精神卫生保健领域的相关利益攸关方。

试验注册号

NCT03226743。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e2e/6887029/30d7b84e59dd/bmjopen-2019-032408f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e2e/6887029/30d7b84e59dd/bmjopen-2019-032408f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e2e/6887029/30d7b84e59dd/bmjopen-2019-032408f01.jpg

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