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  • Refractory depression: mechanisms and evaluation of radically open dialectical behaviour therapy (RO-DBT) [REFRAMED]: protocol for randomised trial

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Mental health
Protocol
Refractory depression: mechanisms and evaluation of radically open dialectical behaviour therapy (RO-DBT) [REFRAMED]: protocol for randomised trial
  1. T R Lynch1,
  2. B Whalley2,
  3. R J Hempel1,
  4. S Byford3,
  5. P Clarke4,
  6. S Clarke5,
  7. D Kingdon6,
  8. H O'Mahen7,
  9. I T Russell8,
  10. J Shearer9,
  11. M Stanton10,
  12. M Swales11,
  13. A Watkins8,
  14. B Remington1
  1. 1Department of Psychology, University of Southampton, Southampton, UK
  2. 2Department of Psychology, University of Plymouth, Plymouth, UK
  3. 3Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK
  4. 4Institute for Social and Economic Research, University of Essex, Colchester, UK
  5. 5University Department of Mental Health, Bournemouth University and Intensive Psychological Therapies Service, Dorset Health Care University NHS Foundation Trust, Poole, UK
  6. 6Department of Medicine, University of Southampton, Southampton, UK
  7. 7Mood Disorders Centre, University of Exeter, Exeter, UK
  8. 8College of Medicine, Swansea University, Swansea, UK
  9. 9Primary Care and Public Health Sciences, King's College London, London, UK
  10. 10Psychology Services, Southern Health NHS Foundation Trust, Winchester, UK
  11. 11School of Psychology, Bangor University, Bangor, UK
  1. Correspondence to Dr RJ Hempel; R.Hempel{at}soton.ac.uk

Abstract

Introduction 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 and analysis 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.

Ethics and dissemination The National Research Ethics Service (NRES) Committee South Central – Southampton A first granted ethical approval on 20 June 2011, reference number 11/SC/0146.

Trial registration number ISRCTN85784627.

  • Refractory Depression
  • Radically Open Dialectical Behaviour Therapy
  • Study Protocol

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

https://doi.org/10.1136/bmjopen-2015-008857

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