Netherlands Institute of Mental Health and Addiction (Trimbos-institute), Utrecht, the Netherlands.
BMC Health Serv Res. 2009 Sep 8;9:159. doi: 10.1186/1472-6963-9-159.
Panic disorder (PD) and generalized anxiety disorder (GAD) are two of the most disabling and costly anxiety disorders seen in primary care. However, treatment quality of these disorders in primary care generally falls beneath the standard of international guidelines. Collaborative stepped care is recommended for improving treatment of anxiety disorders, but cost-effectiveness of such an intervention has not yet been assessed in primary care. This article describes the aims and design of a study that is currently underway. The aim of this study is to evaluate effects and costs of a collaborative stepped care approach in the primary care setting for patients with PD and GAD compared with care as usual.
METHODS/DESIGN: The study is a two armed, cluster randomized controlled trial. Care managers and their primary care practices will be randomized to deliver either collaborative stepped care (CSC) or care as usual (CAU). In the CSC group a general practitioner, care manager and psychiatrist work together in a collaborative care framework. Stepped care is provided in three steps: 1) guided self-help, 2) cognitive behavioral therapy and 3) antidepressant medication. Primary care patients with a DSM-IV diagnosis of PD and/or GAD will be included. 134 completers are needed to attain sufficient power to show a clinically significant effect of 1/2 SD on the primary outcome measure, the Beck Anxiety Inventory (BAI). Data on anxiety symptoms, mental and physical health, quality of life, health resource use and productivity will be collected at baseline and after three, six, nine and twelve months.
It is hypothesized that the collaborative stepped care intervention will be more cost-effective than care as usual. The pragmatic design of this study will enable the researchers to evaluate what is possible in real clinical practice, rather than under ideal circumstances. Many requirements for a high quality trial are being met. Results of this study will contribute to treatment options for GAD and PD in the primary care setting. Results will become available in 2011.
NTR1071.
惊恐障碍（PD）和广泛性焦虑障碍（GAD）是在初级保健中最常见的两种致残和昂贵的焦虑障碍。然而，这些疾病的治疗质量通常低于国际指南的标准。协作分步式护理被推荐用于改善焦虑症的治疗，但这种干预措施在初级保健中的成本效益尚未得到评估。本文介绍了一项正在进行中的研究的目的和设计。本研究的目的是评估在初级保健环境中对惊恐障碍和广泛性焦虑障碍患者进行协作分步式护理与常规护理相比的效果和成本。
方法/设计：该研究是一项两臂、聚类随机对照试验。护理经理及其初级保健实践将被随机分配提供协作分步式护理（CSC）或常规护理（CAU）。在 CSC 组中，全科医生、护理经理和精神科医生在协作护理框架中共同工作。分步式护理分为三个步骤：1）指导自助，2）认知行为疗法，3）抗抑郁药物治疗。将纳入符合 DSM-IV 诊断的惊恐障碍和/或广泛性焦虑障碍的初级保健患者。需要 134 名完成者才能获得足够的效力，以显示主要结局测量，贝克焦虑量表（BAI）的 1/2 SD 的临床显著效果。在基线和三个月、六个月、九个月和十二个月时将收集焦虑症状、心理健康和身体健康、生活质量、卫生资源使用和生产力的数据。
研究假设协作分步式护理干预将比常规护理更具成本效益。该研究的实用设计将使研究人员能够评估在实际临床实践中可能的情况，而不是在理想情况下。许多高质量试验的要求都得到了满足。这项研究的结果将为在初级保健环境中治疗广泛性焦虑症和惊恐障碍提供选择。结果将于 2011 年公布。
NTR1071。
