Randomized Controlled Trial

. 2020 Apr;216(4):204-212.

doi: 10.1192/bjp.2019.53.

Refractory depression - mechanisms and efficacy of radically open dialectical behaviour therapy (RefraMED): findings of a randomised trial on benefits and harms

Thomas R Lynch¹, Roelie J Hempel², Ben Whalley³, Sarah Byford⁴, Rampaul Chamba⁵, Paul Clarke⁶, Susan Clarke⁷, David G Kingdon⁸, Heather O'Mahen⁹, Bob Remington¹⁰, Sophie C Rushbrook¹¹, James Shearer¹², Maggie Stanton¹³, Michaela Swales¹⁴, Alan Watkins¹⁵, Ian T Russell¹⁶

Affiliations

¹ Emeritus Professor of Clinical Psychology, Department of Psychology, University of Southampton, UK.
² Senior Research Fellow, Department of Psychology, University of Southampton, UK.
³ Lecturer in Psychology, Cognition Institute, School of Psychology, Plymouth University, UK.
⁴ Professor of Health Economics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.
⁵ Patient and Public Representative, Member of Trial Management Committee responsible for Public & Patient Inclusion, UK.
⁶ Professor of Social Statistics, Institute for Social and Economic Research, University of Essex, UK.
⁷ Visiting Professor, Consultant Clinical Psychologist, Intensive Psychological Therapies Service, Dorset Healthcare University NHS Foundation Trust, UK.
⁸ Professor of Mental Health Care Delivery, Department of Medicine, University of Southampton, UK.
⁹ Senior Lecturer in Clinical Psychology, Department of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.
¹⁰ Emeritus Professor in Psychology, Department of Psychology, University of Southampton, UK.
¹¹ Consultant Clinical Psychologist, Intensive Psychological Therapies Service, Dorset Healthcare University NHS Foundation Trust, UK.
¹² Lecturer in Health Economics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.
¹³ Consultant Clinical Psychologist, Psychological Services, Southern Health NHS Foundation Trust, UK.
¹⁴ Consultant Clinical Psychologist and Reader in Clinical Psychology, School of Psychology, Bangor University, UK.
¹⁵ Associate Professor of e-Trials Research, Medical School, Swansea University, UK.
¹⁶ Professor of Clinical Trials, Medical School, Swansea University, UK.

PMID: 31317843
PMCID: PMC7282863
DOI: 10.1192/bjp.2019.53

Randomized Controlled Trial

Refractory depression - mechanisms and efficacy of radically open dialectical behaviour therapy (RefraMED): findings of a randomised trial on benefits and harms

Thomas R Lynch et al. Br J Psychiatry. 2020 Apr.

. 2020 Apr;216(4):204-212.

doi: 10.1192/bjp.2019.53.

Authors

Affiliations

¹ Emeritus Professor of Clinical Psychology, Department of Psychology, University of Southampton, UK.
² Senior Research Fellow, Department of Psychology, University of Southampton, UK.
³ Lecturer in Psychology, Cognition Institute, School of Psychology, Plymouth University, UK.
⁴ Professor of Health Economics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.
⁵ Patient and Public Representative, Member of Trial Management Committee responsible for Public & Patient Inclusion, UK.
⁶ Professor of Social Statistics, Institute for Social and Economic Research, University of Essex, UK.
⁷ Visiting Professor, Consultant Clinical Psychologist, Intensive Psychological Therapies Service, Dorset Healthcare University NHS Foundation Trust, UK.
⁸ Professor of Mental Health Care Delivery, Department of Medicine, University of Southampton, UK.
⁹ Senior Lecturer in Clinical Psychology, Department of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.
¹⁰ Emeritus Professor in Psychology, Department of Psychology, University of Southampton, UK.
¹¹ Consultant Clinical Psychologist, Intensive Psychological Therapies Service, Dorset Healthcare University NHS Foundation Trust, UK.
¹² Lecturer in Health Economics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.
¹³ Consultant Clinical Psychologist, Psychological Services, Southern Health NHS Foundation Trust, UK.
¹⁴ Consultant Clinical Psychologist and Reader in Clinical Psychology, School of Psychology, Bangor University, UK.
¹⁵ Associate Professor of e-Trials Research, Medical School, Swansea University, UK.
¹⁶ Professor of Clinical Trials, Medical School, Swansea University, UK.

PMID: 31317843
PMCID: PMC7282863
DOI: 10.1192/bjp.2019.53

Abstract

Background: Individuals with depression often do not respond to medication or psychotherapy. Radically open dialectical behaviour therapy (RO DBT) is a new treatment targeting overcontrolled personality, common in refractory depression.

Aims: To compare RO DBT plus treatment as usual (TAU) for refractory depression with TAU alone (trial registration: ISRCTN 85784627).

Method: RO DBT comprised 29 therapy sessions and 27 skills classes over 6 months. Our completed randomised trial evaluated RO DBT for refractory depression over 18 months in three British secondary care centres. Of 250 adult participants, we randomised 162 (65%) to RO DBT. The primary outcome was the Hamilton Rating Scale for Depression (HRSD), assessed masked and analysed by treatment allocated.

Results: After 7 months, immediately following therapy, RO DBT had significantly reduced depressive symptoms by 5.40 points on the HRSD relative to TAU (95% CI 0.94-9.85). After 12 months (primary end-point), the difference of 2.15 points on the HRSD in favour of RO DBT was not significant (95% CI -2.28 to 6.59); nor was that of 1.69 points on the HRSD at 18 months (95% CI -2.84 to 6.22). Throughout RO DBT participants reported significantly better psychological flexibility and emotional coping than controls. However, they reported eight possible serious adverse reactions compared with none in the control group.

Conclusions: The RO DBT group reported significantly lower HRSD scores than the control group after 7 months, but not thereafter. The imbalance in serious adverse reactions was probably because of the controls' limited opportunities to report these.

Keywords: Treatment-resistant depression; chronic depression; personality disorder; radically open dialectical behaviour therapy (RO DBT); randomised controlled trial.

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Conflict of interest statement

Declaration of interest: Six of the 16 authors have received royalties or fees for RO DBT. R.J.H. is co-owner and director of Radically Open Ltd, the RO DBT training and dissemination company. D.K. reports grants outside the submitted work from NIHR. T.R.L. receives royalties from New Harbinger Publishing for sales of RO DBT treatment manuals, speaking fees from Radically Open Ltd and a grant outside the submitted work from the Medical Research Council. He was codirector of Radically Open Ltd between November 2014 and May 2015 and is married to Erica Smith-Lynch, the principal shareholder and one of two current directors of Radically Open Ltd. H.O’M. reports personal fees from the Charlie Waller Institute and Improving Access to Psychological Therapy. S.C.R. provides RO DBT supervision through S C Rushbrook Ltd. I.T.R. reports grants outside the submitted work from NIHR and Health & Care Research Wales. M.St. reports personal fees from British Isles DBT Training, Stanton Psychological Services Ltd, and Taylor & Francis Ltd. M.Sw. reports personal fees from British Isles DBT Training, Guilford Press, Oxford University Press and Taylor & Francis Ltd. B.W. was codirector of Radically Open Ltd between November 2014 and February 2015.

Figures

**Fig. 1**
CONSORT diagram showing flow of participants through the Refractory depression: mechanisms and effectiveness of radically open-dialectical behaviour therapy (RefraMED) trial, including numbers analysed at each assessment.

**Fig. 2**
Hamilton Rating Scale for Depression (HRSD) and secondary outcomes by group.

**Fig. 3**
Cumulative probability that difference in Hamilton Rating Scale for Depression score between groups (D) exceeds X at months 0, 7, 12 and 18.

See this image and copyright information in PMC

References

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Refractory depression - mechanisms and efficacy of radically open dialectical behaviour therapy (RefraMED): findings of a randomised trial on benefits and harms

Affiliations

Refractory depression - mechanisms and efficacy of radically open dialectical behaviour therapy (RefraMED): findings of a randomised trial on benefits and harms

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Research Materials