RT Journal Article T1 Transdiagnostic cognitive behavioral therapy versus treatment asusual in adult patients with emotional disorders in the primarycaresetting (PsicAP Study): protocol for a Randomized Controlled Trial A1 Cano Vindel, Antonio A1 Muñoz Navarro, Roger A1 Wood, Cristina Mae A1 Limonero, Joaquín T A1 Medrano, Leonardo Adrián A1 Ruiz Rodríguez, Paloma A1 Gracia Gracia, Irene A1 Dongil Collado, Esperanza A1 Iruarrizaga Díez, María Icíar A1 Chacón Fuertes, Fernando A1 Santolaya, Francisco AB 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). PB JMIR Publications SN 1929-0748 YR 2016 FD 2016-12-23 LK https://hdl.handle.net/20.500.14352/17586 UL https://hdl.handle.net/20.500.14352/17586 LA eng NO Ministerio de Economía y Competitividad (MINECO) NO Fundación Mutua Madrileña DS Docta Complutense RD 10 sept 2024