基层医疗环境中成年情绪障碍患者的跨诊断认知行为疗法与常规治疗对照研究（PsicAP研究）：一项随机对照试验方案
Transdiagnostic Cognitive Behavioral Therapy Versus Treatment as Usual in Adult Patients With Emotional Disorders in the Primary Care Setting (PsicAP Study): Protocol for a Randomized Controlled Trial.
作者信息
Cano-Vindel Antonio, Muñoz-Navarro Roger, Wood Cristina Mae, Limonero Joaquín T, Medrano Leonardo Adrián, Ruiz-Rodríguez Paloma, Gracia-Gracia Irene, Dongil-Collado Esperanza, Iruarrizaga Iciar, Chacón Fernando, Santolaya Francisco
机构信息
PsicAP Research Group, Complutense University of Madrid, Madrid, Spain.
Faculty of Psychology, Complutense University of Madrid, Madrid, Spain.
出版信息
JMIR Res Protoc. 2016 Dec 23;5(4):e246. doi: 10.2196/resprot.6351.
BACKGROUND
Demand for primary care (PC) services in Spain exceeds available resources. Part of this strong demand is due to the high prevalence of emotional disorders (EDs)-anxiety, depression, and somatic symptom disorders-and related comorbidities such as pain or chronic illnesses. EDs are often under- or misdiagnosed by general practitioners (GPs) and, consequently, treatment is frequently inadequate.
OBJECTIVE
We aim to compare the short- and long-term effectiveness of group-delivered transdiagnostic cognitive behavioral therapy (TD-CBT) versus treatment as usual (TAU) in the treatment of EDs in the PC setting in Spain. We also aim to compare the effect of these treatments on disability, quality of life, cognitive-emotional factors, and treatment satisfaction.
METHODS
Here we present the study design of a two-arm, single-blind, randomized controlled trial (N=1126) to compare TAU to TD-CBT for EDs. TAU will consist primarily of pharmacological treatment and practical advice from the GP while TD-CBT will be administered in seven 90-minute group sessions held over a period ranging from 12 to 14 weeks. Psychological assessments are carried out at baseline (ie, pretreatment); posttreatment; and at 3-, 6-, and 12-month follow-up. The study is conducted in approximately 26 PC centers from the National Health System in Spain.
RESULTS
This study was initiated in December 2013 and will remain open to new participants until recruitment and follow-up has been completed. We expect all posttreatment evaluations to be completed by December 2017, and follow-up will end in December 2018.
CONCLUSIONS
We expect the TD-CBT group to have better results compared to TAU on all posttreatment measures and that this improvement will be maintained during follow-up. This project could serve as a model for use in other areas or services of the National Health System in Spain and even in other countries.
CLINICALTRIAL
International Standard Randomized Controlled Trial Number (ISRCTN): 58437086; http://www.isrctn.com/ISRCTN58437086 (Archived by WebCite at http://www.webcitation.org/6mbYjQSn3).
背景
西班牙对初级保健（PC）服务的需求超过了可用资源。这种强烈需求的部分原因是情绪障碍（EDs）——焦虑、抑郁和躯体症状障碍——以及相关合并症（如疼痛或慢性病）的高患病率。全科医生（GPs）往往对EDs诊断不足或误诊，因此治疗常常不充分。
目的
我们旨在比较团体提供的跨诊断认知行为疗法（TD-CBT）与常规治疗（TAU）在西班牙初级保健环境中治疗EDs的短期和长期效果。我们还旨在比较这些治疗对残疾、生活质量、认知情感因素和治疗满意度的影响。
方法
在此，我们介绍一项双臂、单盲、随机对照试验（N = 1126）的研究设计，以比较TAU和TD-CBT治疗EDs的效果。TAU主要包括药物治疗和全科医生的实用建议，而TD-CBT将在12至14周内进行七次90分钟的团体治疗。在基线（即治疗前）、治疗后以及3个月、6个月和12个月随访时进行心理评估。该研究在西班牙国家卫生系统的约26个初级保健中心进行。
结果
本研究于2013年12月启动，在招募和随访完成之前将继续对新参与者开放。我们预计所有治疗后评估将于2017年12月完成，随访将于2018年12月结束。
结论
我们预计TD-CBT组在所有治疗后测量指标上的结果都将优于TAU组，并且这种改善在随访期间将得以维持。该项目可作为西班牙国家卫生系统其他领域或服务甚至其他国家使用的模型。
临床试验
国际标准随机对照试验编号（ISRCTN）：58437086；http://www.isrctn.com/ISRCTN58437086（由WebCite存档于http://www.webcitation.org/6mbYjQSn3）
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