title: Efficacy of a cognitive and behavioural psychotherapy applied by primary care psychologists in patients with mixed anxiety-depressive disorder: a research protocol.
abstract: BACKGROUND
  In contrast with the recommendations of clinical practice guidelines, the most common treatment for anxiety and depressive disorders in primary care is pharmacological. The aim of this study is to assess the efficacy of a cognitive-behavioural psychological intervention, delivered by primary care psychologists in patients with mixed anxiety-depressive disorder compared to usual care.
  
  
  METHODS
  This is an open-label, multicentre, randomized, and controlled study with two parallel groups. A random sample of 246 patients will be recruited with mild-to-moderate mixed anxiety-depressive disorder, from the target population on the lists of 41 primary care doctors. Patients will be randomly assigned to the intervention group, who will receive standardised cognitive-behavioural therapy delivered by psychologists together with usual care, or to a control group, who will receive usual care alone. The cognitive-behavioural therapy intervention is composed of eight individual 60-minute face-to face sessions conducted in eight consecutive weeks. A follow-up session will be conducted over the telephone, for reinforcement or referral as appropriate, 6 months after the intervention, as required. The primary outcome variable will be the change in scores on the Short Form-36 General Health Survey. We will also measure the change in the frequency and intensity of anxiety symptoms (State-Trait Anxiety Inventory) and depression (Beck Depression Inventory) at baseline, and 3, 6 and 12 months later. Additionally, we will collect information on the use of drugs and health care services.
  
  
  CONCLUSIONS
  The aim of this study is to assess the efficacy of a primary care-based cognitive-behavioural psychological intervention in patients with mixed anxiety-depressive disorder. The international scientific evidence has demonstrated the need for psychologists in primary care. However, given the differences between health policies and health services, it is important to test the effect of these psychological interventions in our geographical setting.
  
  
  BACKGROUND
  NCT01907035 (July 22, 2013).
authors: Sopela Health Centre, Basque Health Service (Osakidetza), Sopela, Spain. amale.jaureguilarrabeiti@osakidetza.net.
authors: Amale
authors: A
authors: Jauregui
authors: Ortuella Mental Health Service, Ortuella, Spain. joaquin.pontevelon@osakidetza.net.
authors: Joaquín
authors: J
authors: Ponte
authors: Primary Care Research Unit of Bizkaia (UIAPB)- Osakidetza, Luis Power 18, 4ª planta, E-48014, Bilbao, Spain. monika.salgueiromacho@osakidetza.net.|Basic Psychological Processes and Development Department, Faculty of Psychology, University of the Basque Country (UPV/EHU), Donostia-San Sebastian, Spain. monika.salgueiromacho@osakidetza.net.
authors: Monika
authors: M
authors: Salgueiro
authors: Sopela Health Centre, Basque Health Service (Osakidetza), Sopela, Spain. saloa.investigacion@gmail.com.|School of Nursing, University of the Basque Country (UPV/EHU), Leioa, Spain. saloa.investigacion@gmail.com.
authors: Saloa
authors: S
authors: Unanue
authors: Rontegui Health Centre, Barakaldo, Spain. mariadelcarmen.donaireurquijo@osakidetza.net.
authors: Carmen
authors: C
authors: Donaire
authors: Medical Section, I + D department, BIAL, Bilbao, Spain. mariacruz.gomezfernandez@osakidetza.net.
authors: Maria Cruz
authors: MC
authors: Gómez
authors: Primary Care Research Unit of Bizkaia (UIAPB)- Osakidetza, Luis Power 18, 4ª planta, E-48014, Bilbao, Spain. natalia.burgosalonso@osakidetza.net.|Department of Preventive Medicine and Public Health, Faculty of Medicine and Dentistry, University of the Basque Country (UPV/EHU), Leioa, Spain. natalia.burgosalonso@osakidetza.net.
authors: Natalia
authors: N
authors: Burgos-Alonso
authors: Primary Care Research Unit of Bizkaia (UIAPB)- Osakidetza, Luis Power 18, 4ª planta, E-48014, Bilbao, Spain. gonzalo.grandesodriozola@osakidetza.net.
authors: Gonzalo
authors: G
authors: Grandes
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001008:Anxiety Disorders / Q000628:therapy*; D015928:Cognitive Behavioral Therapy; D003866:Depressive Disorder / Q000628:therapy*; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D008297:Male; D008875:Middle Aged; D011320:Primary Health Care / Q000379:methods*; D011788:Quality of Life; D016896:Treatment Outcome; D055815:Young Adult