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Refractory depression – mechanisms and evaluation of Radically Open Dialectical Behaviour Therapy (RO-DBT) [REFRAMED]: protocol for randomised trial

Refractory depression – mechanisms and evaluation of Radically Open Dialectical Behaviour Therapy (RO-DBT) [REFRAMED]: protocol for randomised trial
Refractory depression – mechanisms and evaluation of Radically Open Dialectical Behaviour Therapy (RO-DBT) [REFRAMED]: protocol for randomised trial
Introduction: Only 30% to 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 & Analysis: REFRAMED is a multi-centre randomised controlled trial, comparing seven 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 & Dissemination: The Hampshire Research Ethics Committee first granted ethical approval on 20 June 2011, National Research Ethics Service (NRES) reference number 11/SC/0146. Trial Registration: http://www.isrctn.com/ISRCTN85784627, date assigned 10/08/2011.
1-19
Lynch, T.R.
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Whalley, B.
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Hempel, R.
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Byford, S.
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Clarke, P.
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Kingdon, D.
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O'Mahen, H.
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Russell, I.T.
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Shearer, J.
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Stanton, M.
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Swales, M.
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Watkins, A.
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Remington, B.
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Lynch, T.R.
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Whalley, B.
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Hempel, R.
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Byford, S.
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Clarke, P.
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Kingdon, D.
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O'Mahen, H.
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Russell, I.T.
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Shearer, J.
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Stanton, M.
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Swales, M.
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Watkins, A.
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Remington, B.
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Lynch, T.R., Whalley, B., Hempel, R., Byford, S., Clarke, P., Kingdon, D., O'Mahen, H., Russell, I.T., Shearer, J., Stanton, M., Swales, M., Watkins, A. and Remington, B. (2015) Refractory depression – mechanisms and evaluation of Radically Open Dialectical Behaviour Therapy (RO-DBT) [REFRAMED]: protocol for randomised trial. BMJ Open, 1-19.

Record type: Article

Abstract

Introduction: Only 30% to 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 & Analysis: REFRAMED is a multi-centre randomised controlled trial, comparing seven 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 & Dissemination: The Hampshire Research Ethics Committee first granted ethical approval on 20 June 2011, National Research Ethics Service (NRES) reference number 11/SC/0146. Trial Registration: http://www.isrctn.com/ISRCTN85784627, date assigned 10/08/2011.

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REFRAMED protocol paper 22-06-2015_for printing - all changes accepted.docx - Accepted Manuscript
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More information

Accepted/In Press date: 30 June 2015
e-pub ahead of print date: 2015
Organisations: Psychology, Clinical & Experimental Sciences

Identifiers

Local EPrints ID: 379129
URI: https://eprints.soton.ac.uk/id/eprint/379129
PURE UUID: 8444669d-7f12-4a0f-afe9-db38570a9b01
ORCID for T.R. Lynch: ORCID iD orcid.org/0000-0003-1270-6097

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Date deposited: 14 Jul 2015 11:30
Last modified: 13 Jun 2019 00:34

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Contributors

Author: T.R. Lynch ORCID iD
Author: B. Whalley
Author: R. Hempel
Author: S. Byford
Author: P. Clarke
Author: D. Kingdon
Author: H. O'Mahen
Author: I.T. Russell
Author: J. Shearer
Author: M. Stanton
Author: M. Swales
Author: A. Watkins
Author: B. Remington

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