惊恐障碍的早期干预：随机对照试验与成本效益分析。

Early intervention in panic: randomized controlled trial and cost-effectiveness analysis.

作者信息

Meulenbeek Peter, Willemse Godelief, Smit Filip, van Balkom Anton, Spinhoven Philip, Cuijpers Pim

机构信息

Department of Clinical Psychology and EMGO Institute, VU-University, Amsterdam, The Netherlands, GGNet, Community Mental Health Center, Warnsveld, The Netherlands.

出版信息

Trials. 2008 Nov 27;9:67. doi: 10.1186/1745-6215-9-67.

DOI:10.1186/1745-6215-9-67

PMID:19038038

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2630960/

Abstract

BACKGROUND

Panic disorder (PD) is a common, severe and persistent mental disorder, associated with a high degree of distress and occupational and social disability. A substantial proportion of the population experiences subthreshold and mild PD and is at risk of developing a chronic PD. A promising intervention, aimed at preventing panic disorder onset and reducing panic symptoms, is the 'Don't Panic' course. It consists of eight sessions of two hours each. The purpose of this study is to evaluate the effectiveness of this early intervention - based on cognitive behavioural principles - on the reduction of panic disorder symptomatology. We predict that the experimental condition show superior clinical and economic outcomes relative to a waitlisted control group.

METHODS/DESIGN: A pragmatic, pre-post, two-group, multi-site, randomized controlled trial of the intervention will be conducted with a naturalistic follow-up at six months in the intervention group. The participants are recruited from the general population and are randomized to the intervention or a waitlist control group. The intervention is offered by community mental health centres. Included are people over 18 years of age with subthreshold or mild panic disorder, defined as having symptoms of PD falling below the cut-off of 13 on the Panic Disorder Severity Scale-Self Report (PDSS-SR). Primary outcomes are panic disorder and panic symptoms. Secondary outcomes are symptoms of agoraphobia, anxiety, cognitive aspects of panic disorder, depressive symptoms, mastery, health-related quality of life, and cost-effectiveness. We will examine the following variables as potential mediators: cognitive aspects of panic disorder, symptoms of agoraphobia, anxiety and mastery. Potential moderating variables are: socio-demographic characteristics, panic disorder, agoraphobia, treatment credibility and mastery.

DISCUSSION

This study was designed to evaluate the (cost) effectiveness of an early intervention based on cognitive behavioural principles. The strong external validity is one of the strengths of the study design.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN33407455.

摘要

背景

惊恐障碍（PD）是一种常见、严重且持续的精神障碍，伴有高度的痛苦以及职业和社会功能障碍。相当一部分人群经历阈下和轻度惊恐障碍，并有发展为慢性惊恐障碍的风险。一种有前景的干预措施，旨在预防惊恐障碍的发作并减轻惊恐症状，即“别恐慌”课程。该课程由八个两小时的课时组成。本研究的目的是评估这种基于认知行为原则的早期干预对减轻惊恐障碍症状的有效性。我们预测，与等待名单对照组相比，实验组将显示出更好的临床和经济结果。

方法/设计：将对该干预措施进行一项实用的、前后对照、两组、多中心随机对照试验，并在干预组进行为期六个月的自然随访。参与者从普通人群中招募，随机分为干预组或等待名单对照组。干预由社区心理健康中心提供。纳入对象为年龄在18岁以上、患有阈下或轻度惊恐障碍的人群，定义为在惊恐障碍严重程度量表-自我报告（PDSS-SR）上的惊恐障碍症状得分低于13分的临界值。主要结局是惊恐障碍和惊恐症状。次要结局是广场恐惧症、焦虑、惊恐障碍的认知方面、抑郁症状、掌控感、健康相关生活质量以及成本效益。我们将把以下变量作为潜在中介因素进行考察：惊恐障碍的认知方面、广场恐惧症症状、焦虑和掌控感。潜在调节变量为：社会人口学特征、惊恐障碍、广场恐惧症、治疗可信度和掌控感。