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

Thomas R Lynch; Roelie J Hempel; Ben Whalley; Sarah Byford; Rampaul Chamba; Paul Clarke; Susan Clarke; David G Kingdon; Heather O'Mahen; Bob Remington; Sophie C Rushbrook; James Shearer; Maggie Stanton; Michaela Swales; Alan Watkins; Ian T Russell

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

Br J Psychiatry. 2020 Apr;216(4):204-212. doi: 10.1192/bjp.2019.53.

Authors

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.

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.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Depressive Disorder, Major / therapy*
Depressive Disorder, Treatment-Resistant / therapy*
Dialectical Behavior Therapy* / methods
Female
Follow-Up Studies
Humans
Male
Middle Aged
Outcome Assessment, Health Care*
Psychiatric Status Rating Scales
Psychotherapeutic Processes*
Secondary Care

Grants and funding

MRC_/Medical Research Council/United Kingdom