title: Effectiveness of a transdiagnostic internet-based protocol for the treatment of emotional disorders versus treatment as usual in specialized care: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Emotional disorders (depression and anxiety disorders) are highly prevalent mental health problems. Although evidence showing the effectiveness of disorder-specific treatments exists, high comorbidity rates among emotional disorders limit the utility of these protocols. This has led some researchers to focus their interest on transdiagnostic interventions, a treatment perspective that might be more widely effective across these disorders. Also, the current way of delivering treatments makes it difficult provide assistance to all of the population in need. The use of the Internet in the delivery of evidence-based treatments may help to disseminate treatments among the population. In this study, we aim to test the effectiveness of EmotionRegulation, a new transdiagnostic Internet-based protocol for unipolar mood disorders, five anxiety disorders (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder and anxiety disorder not otherwise specified), and obsessive-compulsive disorder in comparison to treatment as usual as provided in Spanish public specialized mental health care. We will also study its potential impact on basic temperament dimensions (neuroticism/behavioral inhibition and extraversion/behavioral activation). Expectations and opinions of patients about this protocol will also be studied.
  
  
  METHODS
  The study is a randomized controlled trial. 200 participants recruited in specialized care will be allocated to one of two treatment conditions: a) EmotionRegulation or b) treatment as usual. Primary outcome measures will be the BAI and the BDI-II. Secondary outcomes will include a specific measure of the principal disorder, and measures of neuroticism/behavioral inhibition and extraversion/behavioral activation. Patients will be assessed at baseline, post-treatment, and 3- and 12-month follow-ups. Intention to treat and per protocol analyses will be performed.
  
  
  CONCLUSIONS
  Although the effectiveness of face-to-face transdiagnostic protocols has been investigated in previous studies, the number of published transdiagnostic Internet-based programs is still quite low. To our knowledge, this is the first randomized controlled trial studying the effectiveness of a transdiagnostic Internet-based treatment for several emotional disorders in public specialized care. Combining both a transdiagnostic approach with an Internet-based therapy format may help to decrease the burden of mental disorders, reducing the difficulties associated with disorder-specific treatments and facilitating access to people in need of treatment. Strengths and limitations are discussed.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02345668 . Registered 27 July 2015.
authors.affiliation: University Jaume I, Research Building II, Office NB2128DD, Vicente Sos Baynat Avenue, Castellon, 12071, Spain. vrobles@uji.es.
authors.forename: Alberto
authors.initials: A
authors.lastname: González-Robles
authors.affiliation: University Jaume I, Research Building II, Office NB2128DD, Vicente Sos Baynat Avenue, Castellon, 12071, Spain. azucena@uji.es.|CIBER Fisiopatología Obesidad y Nutrición (CIBERObn), Instituto Salud Carlos III, Madrid, Spain. azucena@uji.es.
authors.forename: Azucena
authors.initials: A
authors.lastname: García-Palacios
authors.affiliation: Universidad de Valencia, Valencia, Spain. banos@uv.es.|CIBER Fisiopatología Obesidad y Nutrición (CIBERObn), Instituto Salud Carlos III, Madrid, Spain. banos@uv.es.
authors.forename: Rosa
authors.initials: R
authors.lastname: Baños
authors.affiliation: University Jaume I, Research Building II, Office NB2128DD, Vicente Sos Baynat Avenue, Castellon, 12071, Spain. toni.riera82@gmail.com.
authors.forename: Antonio
authors.initials: A
authors.lastname: Riera
authors.affiliation: Psychiatry Service, Consorcio Hospitalario Provincial de Castellón, Castellon, Spain. ginesllorca@hotmail.com.
authors.forename: Ginés
authors.initials: G
authors.lastname: Llorca
authors.affiliation: Psychiatry Service, Consorcio Hospitalario Provincial de Castellón, Castellon, Spain. pacojtraver@gmail.com.
authors.forename: Francisco
authors.initials: F
authors.lastname: Traver
authors.affiliation: Psychiatry Service, Consorcio Hospitalario Provincial de Castellón, Castellon, Spain. gharoc@comv.es.|School of Medicine, Universidad CEU Cardenal Herrera, Castellon, Spain. gharoc@comv.es.
authors.forename: Gonzalo
authors.initials: G
authors.lastname: Haro
authors.affiliation: Psychiatry Service, Departamento de Salud de la Ribera, Hospital Universitario de La Ribera, Valencia, Spain. vpalop@comv.es.
authors.forename: Vicente
authors.initials: V
authors.lastname: Palop
authors.affiliation: Psychiatry Service, Departamento de Salud de la Ribera, Hospital Universitario de La Ribera, Valencia, Spain. guillemlera@gmail.com.
authors.forename: Guillem
authors.initials: G
authors.lastname: Lera
authors.affiliation: Psychiatry Service, Departamento de Salud de la Ribera, Hospital Universitario de La Ribera, Valencia, Spain. JRomeu@hospital-ribera.com.
authors.forename: José Enrique
authors.initials: JE
authors.lastname: Romeu
authors.affiliation: University Jaume I, Research Building II, Office NB2128DD, Vicente Sos Baynat Avenue, Castellon, 12071, Spain. botella@uji.es.|CIBER Fisiopatología Obesidad y Nutrición (CIBERObn), Instituto Salud Carlos III, Madrid, Spain. botella@uji.es.
authors.forename: Cristina
authors.initials: C
authors.lastname: Botella
mesh_terms: D001008:Anxiety Disorders / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D002985:Clinical Protocols; D003695:Delivery of Health Care; D003866:Depressive Disorder / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D004644:Emotions; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D020407:Internet; D008297:Male; D017060:Patient Satisfaction; D011569:Psychiatric Status Rating Scales; D011613:Psychotherapy / Q000379:methods*; D011788:Quality of Life; D012107:Research Design; D013030:Spain; D011795:Surveys and Questionnaires; D013813:Therapy, Computer-Assisted / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome