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

Thomas R. Lynch; Ben Whalley; R J Hempel; Sarah Byford; P. Clarke; S. Clarke; D. Kingdon; Heather O'Mahen; Ian T. Russell; J Shearer; M Stanton; M Swales; Alan Watkins; B Remington

doi:10.1136/bmjopen-2015-008857

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

Thomas R. Lynch
, Ben Whalley
, R J Hempel
, Sarah Byford
, P. Clarke
, S. Clarke
, D. Kingdon
, Heather O'Mahen
, Ian T. Russell
, J Shearer
, M Stanton
, M Swales
, Alan Watkins
, B Remington

University of Southampton
University of Plymouth
Swansea University
King's College London
Southern Health NHS Foundation Trust, Southampton, UK.
University of Exeter
Bournemouth University
University of Essex

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Pages (from-to)	e008857
Journal	BMJ Open
Volume	5
Issue number	7
DOIs	https://doi.org/10.1136/bmjopen-2015-008857
Publication status	Published - 17 Jul 2015

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Behavior Therapy/economics
Cost-Benefit Analysis
Depression/drug therapy
Drug Resistance
Humans
Quality-Adjusted Life Years
Research Design
Retreatment

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10.1136/bmjopen-2015-008857

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Lynch, T. R., Whalley, B., Hempel, R. J., Byford, S., Clarke, P., Clarke, S., Kingdon, D., O'Mahen, H., Russell, I. T., Shearer, J., Stanton, M., Swales, M., Watkins, A., & Remington, B. (2015). Refractory depression: mechanisms and evaluation of radically open dialectical behaviour therapy (RO-DBT) [REFRAMED]: protocol for randomised trial. BMJ Open, 5(7), e008857. https://doi.org/10.1136/bmjopen-2015-008857

@article{94cfabcf44d943ffa998b961e33f6b9b,

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

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.",

keywords = "Behavior Therapy/economics, Cost-Benefit Analysis, Depression/drug therapy, Drug Resistance, Humans, Quality-Adjusted Life Years, Research Design, Retreatment",

author = "Lynch, \{Thomas R.\} and Ben Whalley and Hempel, \{R J\} and Sarah Byford and P. Clarke and S. Clarke and D. Kingdon and Heather O'Mahen and Russell, \{Ian T.\} and J Shearer and M Stanton and M Swales and Alan Watkins and B Remington",

note = "Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.",

year = "2015",

month = jul,

day = "17",

doi = "10.1136/bmjopen-2015-008857",

language = "English",

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Lynch, TR, Whalley, B, Hempel, RJ, Byford, S, Clarke, P, Clarke, S, Kingdon, D, O'Mahen, H, Russell, IT, Shearer, J, Stanton, M, Swales, M, Watkins, A & Remington, B 2015, 'Refractory depression: mechanisms and evaluation of radically open dialectical behaviour therapy (RO-DBT) [REFRAMED]: protocol for randomised trial', BMJ Open, vol. 5, no. 7, pp. e008857. https://doi.org/10.1136/bmjopen-2015-008857

TY - JOUR

T1 - Refractory depression

T2 - mechanisms and evaluation of radically open dialectical behaviour therapy (RO-DBT) [REFRAMED]: protocol for randomised trial

AU - Lynch, Thomas R.

AU - Whalley, Ben

AU - Hempel, R J

AU - Byford, Sarah

AU - Clarke, P.

AU - Clarke, S.

AU - Kingdon, D.

AU - O'Mahen, Heather

AU - Russell, Ian T.

AU - Shearer, J

AU - Stanton, M

AU - Swales, M

AU - Watkins, Alan

AU - Remington, B

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

PY - 2015/7/17

Y1 - 2015/7/17

N2 - 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.

AB - 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.

KW - Behavior Therapy/economics

KW - Cost-Benefit Analysis

KW - Depression/drug therapy

KW - Drug Resistance

KW - Humans

KW - Quality-Adjusted Life Years

KW - Research Design

KW - Retreatment

U2 - 10.1136/bmjopen-2015-008857

DO - 10.1136/bmjopen-2015-008857

M3 - Article

C2 - 26187121

SN - 2044-6055

VL - 5

SP - e008857

JO - BMJ Open

JF - BMJ Open

IS - 7

ER -

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

Abstract

UN SDGs

Keywords

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