Abstract
BackgroundDemand 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.ObjectiveWe 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.MethodsHere 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.ResultsThis 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.ConclusionsWe 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.ClinicalTrialInternational Standard Randomized Controlled Trial Number (ISRCTN): 58437086; http://www.isrctn.com/ISRCTN58437086 (Archived by WebCite at http://www.webcitation.org/6mbYjQSn3)
Highlights
Background and RationaleEmotional disorders (EDs), including mood, anxiety, and somatization disorders, are a leading cause of disability and demand for primary care (PC) services [1,2]
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
Summary
Background and RationaleEmotional disorders (EDs), including mood, anxiety, and somatization disorders, are a leading cause of disability and demand for primary care (PC) services [1,2]. In 2001, the World Health Organization (WHO) estimated that the prevalence of mental disorders would continue to increase through the year 2020, imposing a significant social and economic burden on many countries around the world, especially in developed countries. For this reason, the WHO stressed the need to increase the number of specialized human resources to treat patients with EDs [9]. 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, treatment is frequently inadequate
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