title: 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.
abstract: 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.
  
  
  BACKGROUND
  International Standard Randomized Controlled Trial Number (ISRCTN): 58437086; http://www.isrctn.com/ISRCTN58437086 (Archived by WebCite at http://www.webcitation.org/6mbYjQSn3).
authors.affiliation: PsicAP Research Group, Complutense University of Madrid, Madrid, Spain.|Faculty of Psychology, Complutense University of Madrid, Madrid, Spain.
authors.forename: Antonio
authors.identifier: http://orcid.org/0000-0002-5449-5454
authors.initials: A
authors.lastname: Cano-Vindel
authors.affiliation: PsicAP Research Group, Complutense University of Madrid, Madrid, Spain.|Faculty of Psychology, University of Valencia, Valencia, Spain.
authors.forename: Roger
authors.identifier: http://orcid.org/0000-0002-7064-3699
authors.initials: R
authors.lastname: Muñoz-Navarro
authors.affiliation: PsicAP Research Group, Complutense University of Madrid, Madrid, Spain.|Faculty of Psychology, Complutense University of Madrid, Madrid, Spain.
authors.forename: Cristina Mae
authors.identifier: http://orcid.org/0000-0002-5896-0456
authors.initials: CM
authors.lastname: Wood
authors.affiliation: PsicAP Research Group, Complutense University of Madrid, Madrid, Spain.|Faculty of Psychology, Autonomous University of Barcelona, Barcelona, Spain.
authors.forename: Joaquín T
authors.identifier: http://orcid.org/0000-0003-0573-791X
authors.initials: JT
authors.lastname: Limonero
authors.affiliation: PsicAP Research Group, Complutense University of Madrid, Madrid, Spain.|Faculty of Psychology, Universidad Siglo 21, Córdoba, Argentina.
authors.forename: Leonardo Adrián
authors.identifier: http://orcid.org/0000-0002-3371-5040
authors.initials: LA
authors.lastname: Medrano
authors.affiliation: PsicAP Research Group, Complutense University of Madrid, Madrid, Spain.|Fuenlabrada Primary Care Center, Health Service of Madrid, Madrid, Spain.
authors.forename: Paloma
authors.identifier: http://orcid.org/0000-0001-8140-0767
authors.initials: P
authors.lastname: Ruiz-Rodríguez
authors.affiliation: PsicAP Research Group, Complutense University of Madrid, Madrid, Spain.
authors.forename: Irene
authors.identifier: http://orcid.org/0000-0002-9990-5437
authors.initials: I
authors.lastname: Gracia-Gracia
authors.affiliation: PsicAP Research Group, Complutense University of Madrid, Madrid, Spain.|Faculty of Psychology, Catholic University of Valencia, Valencia, Spain.
authors.forename: Esperanza
authors.identifier: http://orcid.org/0000-0003-1614-2292
authors.initials: E
authors.lastname: Dongil-Collado
authors.affiliation: PsicAP Research Group, Complutense University of Madrid, Madrid, Spain.|Faculty of Social Work, Complutense University of Madrid, Madrid, Spain.
authors.forename: Iciar
authors.identifier: http://orcid.org/0000-0001-5495-7172
authors.initials: I
authors.lastname: Iruarrizaga
authors.affiliation: PsicAP Research Group, Complutense University of Madrid, Madrid, Spain.|Faculty of Psychology, Complutense University of Madrid, Madrid, Spain.|Spanish Association of Psychologists, Madrid, Spain.
authors.forename: Fernando
authors.identifier: http://orcid.org/0000-0002-9649-0774
authors.initials: F
authors.lastname: Chacón
authors.affiliation: PsicAP Research Group, Complutense University of Madrid, Madrid, Spain.|Spanish Association of Psychologists, Madrid, Spain.|Malva-Rosa Mental Health Service, Valencia, Spain.
authors.forename: Francisco
authors.identifier: http://orcid.org/0000-0002-1639-5815
authors.initials: F
authors.lastname: Santolaya
keywords: anxiety; cognitive behavioral therapy; common mental health disorders; depression; emotional disorders; medically unexplained symptoms; primary care; quality of life; somatization; transdiagnostic therapy; treatment as usual