Institute of General Practice and Family Medicine, Jena University Hospital, Friedrich-Schiller-University, Bachstrasse 18, D-07743 Jena, Germany.
Trials. 2014 Apr 6;15:112. doi: 10.1186/1745-6215-15-112.
Panic disorder and agoraphobia are debilitating and frequently comorbid anxiety disorders. A large number of patients with these conditions are treated by general practitioners in primary care. Cognitive behavioural exposure exercises have been shown to be effective in reducing anxiety symptoms. Practice team-based case management can improve clinical outcomes for patients with chronic diseases in primary care. The present study compares a practice team-supported, self-managed exposure programme for patients with panic disorder with or without agoraphobia in small general practices to usual care in terms of clinical efficacy and cost-effectiveness.
METHODS/DESIGN: This is a cluster randomised controlled superiority trial with a two-arm parallel group design. General practices represent the units of randomisation. General practitioners recruit adult patients with panic disorder with or without agoraphobia according to the International Classification of Diseases, version 10 (ICD-10). In the intervention group, patients receive cognitive behaviour therapy-oriented psychoeducation and instructions to self-managed exposure exercises in four manual-based appointments with the general practitioner. A trained health care assistant from the practice team delivers case management and is continuously monitoring symptoms and treatment progress in ten protocol-based telephone contacts with patients. In the control group, patients receive usual care from general practitioners. Outcomes are measured at baseline (T0), at follow-up after six months (T1), and at follow-up after twelve months (T2). The primary outcome is clinical severity of anxiety of patients as measured by the Beck Anxiety Inventory (BAI). To detect a standardised effect size of 0.35 at T1, 222 patients from 37 general practices are included in each group. Secondary outcomes include anxiety-related clinical parameters and health-economic costs.
Current Controlled Trials [http://ISCRTN64669297].
惊恐障碍和广场恐惧症是使人虚弱且经常并发的焦虑症。大量患有这些疾病的患者在初级保健的全科医生处接受治疗。认知行为暴露练习已被证明可有效减轻焦虑症状。实践团队为基础的病例管理可以改善初级保健中慢性疾病患者的临床结果。本研究比较了在小型全科实践中，实践团队支持的、患者自我管理的惊恐障碍伴或不伴广场恐惧症暴露方案与常规护理在临床疗效和成本效益方面的差异。
方法/设计：这是一项具有两臂平行组设计的集群随机对照优势试验。全科医生诊所是随机分组的单位。全科医生根据国际疾病分类第 10 版（ICD-10）招募患有惊恐障碍伴或不伴广场恐惧症的成年患者。在干预组中，患者接受认知行为治疗为导向的心理教育，并在与全科医生的四次预约中接受自我管理暴露练习的指导。来自实践团队的经过培训的医疗保健助理提供病例管理，并通过与患者进行十次基于方案的电话联系，持续监测症状和治疗进展。在对照组中，患者接受全科医生的常规护理。在基线（T0）、六个月后的随访（T1）和十二个月后的随访（T2）时测量结果。主要结局是使用贝克焦虑量表（BAI）测量的患者焦虑的临床严重程度。为了在 T1 时检测到 0.35 的标准化效应量，每组包括 222 名来自 37 家全科医生诊所的患者。次要结局包括焦虑相关的临床参数和健康经济学成本。
当前对照试验[http://ISCRTN64669297]。
