title: Refractory depression: mechanisms and evaluation of radically open dialectical behaviour therapy (RO-DBT) [REFRAMED]: protocol for randomised trial.
abstract: BACKGROUND
  Only 30-40% of depressed patients treated with medication achieve full remission. Studies that change medication or augment it by psychotherapy achieve only limited benefits, in part because current treatments are not designed for chronic and complex patients. Previous trials have excluded high-risk patients and those with comorbid personality disorder. Radically Open Dialectical Behaviour Therapy (RO-DBT) is a novel, transdiagnostic treatment for disorders of emotional over-control. The REFRAMED trial aims to evaluate the effectiveness and cost-effectiveness of RO-DBT for patients with treatment-resistant depression.
  
  
  METHODS
  REFRAMED is a multicentre randomised controlled trial, comparing 7 months of individual and group RO-DBT treatment with treatment as usual (TAU). Our primary outcome measure is depressive symptoms 12 months after randomisation. We shall estimate the cost-effectiveness of RO-DBT by cost per quality-adjusted life year. Causal analyses will explore the mechanisms by which RO-DBT is effective.
  
  
  BACKGROUND
  The National Research Ethics Service (NRES) Committee South Central - Southampton A first granted ethical approval on 20 June 2011, reference number 11/SC/0146.
  
  
  BACKGROUND
  ISRCTN85784627.
authors.affiliation: Department of Psychology, University of Southampton, Southampton, UK.
authors.forename: T R
authors.initials: TR
authors.lastname: Lynch
authors.affiliation: Department of Psychology, University of Plymouth, Plymouth, UK.
authors.forename: B
authors.initials: B
authors.lastname: Whalley
authors.affiliation: Department of Psychology, University of Southampton, Southampton, UK.
authors.forename: R J
authors.identifier: http://orcid.org/0000-0001-9042-2319
authors.initials: RJ
authors.lastname: Hempel
authors.affiliation: Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
authors.forename: S
authors.initials: S
authors.lastname: Byford
authors.affiliation: Institute for Social and Economic Research, University of Essex, Colchester, UK.
authors.forename: P
authors.initials: P
authors.lastname: Clarke
authors.affiliation: University Department of Mental Health, Bournemouth University and Intensive Psychological Therapies Service, Dorset Health Care University NHS Foundation Trust, Poole, UK.
authors.forename: S
authors.initials: S
authors.lastname: Clarke
authors.affiliation: Department of Medicine, University of Southampton, Southampton, UK.
authors.forename: D
authors.initials: D
authors.lastname: Kingdon
authors.affiliation: Mood Disorders Centre, University of Exeter, Exeter, UK.
authors.forename: H
authors.initials: H
authors.lastname: O'Mahen
authors.affiliation: College of Medicine, Swansea University, Swansea, UK.
authors.forename: I T
authors.initials: IT
authors.lastname: Russell
authors.affiliation: Primary Care and Public Health Sciences, King's College London, London, UK.
authors.forename: J
authors.initials: J
authors.lastname: Shearer
authors.affiliation: Psychology Services, Southern Health NHS Foundation Trust, Winchester, UK.
authors.forename: M
authors.initials: M
authors.lastname: Stanton
authors.affiliation: School of Psychology, Bangor University, Bangor, UK.
authors.forename: M
authors.initials: M
authors.lastname: Swales
authors.affiliation: College of Medicine, Swansea University, Swansea, UK.
authors.forename: A
authors.initials: A
authors.lastname: Watkins
authors.affiliation: Department of Psychology, University of Southampton, Southampton, UK.
authors.forename: B
authors.initials: B
authors.lastname: Remington
mesh_terms: D001521:Behavior Therapy / Q000191:economics / Q000379:methods*; D003362:Cost-Benefit Analysis; D003863:Depression / Q000188:drug therapy / Q000191:economics / Q000628:therapy*; D004351:Drug Resistance; D006801:Humans; D019057:Quality-Adjusted Life Years; D012107:Research Design; D019233:Retreatment
keywords: Radically Open Dialectical Behaviour Therapy; Refractory Depression; Study Protocol