Evidence map›Paper›PMID 31317843›Full record

Trial reportThe British journal of psychiatry : the journal of mental science2020

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 and 6 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The British journal of psychiatry : the journal of mental science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
4.9field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. The utility of coping through emotional approach: A meta-analysis.Health psychology : official journal of the Division of Health Psychology, American Psychological Association · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 9 institutions in 1 country.

Thomas R LynchEmeritus Professor of Clinical Psychology, Department of Psychology, University of Southampton, UK.ORCID 0000-0003-1270-6097
Roelie J HempelSenior Research Fellow, Department of Psychology, University of Southampton, UK.
Ben WhalleyLecturer in Psychology, Cognition Institute, School of Psychology, Plymouth University, UK.
Sarah ByfordProfessor of Health Economics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.ORCID 0000-0001-7084-1495
Rampaul ChambaPatient and Public Representative, Member of Trial Management Committee responsible for Public & Patient Inclusion, UK.
Paul ClarkeProfessor of Social Statistics, Institute for Social and Economic Research, University of Essex, UK.
Susan ClarkeVisiting Professor, Consultant Clinical Psychologist, Intensive Psychological Therapies Service, Dorset Healthcare University NHS Foundation Trust, UK.
David G KingdonProfessor of Mental Health Care Delivery, Department of Medicine, University of Southampton, UK.
Heather O'MahenSenior Lecturer in Clinical Psychology, Department of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.
Bob RemingtonEmeritus Professor in Psychology, Department of Psychology, University of Southampton, UK.
Sophie C RushbrookConsultant Clinical Psychologist, Intensive Psychological Therapies Service, Dorset Healthcare University NHS Foundation Trust, UK.
James ShearerLecturer in Health Economics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.
Maggie StantonConsultant Clinical Psychologist, Psychological Services, Southern Health NHS Foundation Trust, UK.
Michaela SwalesConsultant Clinical Psychologist and Reader in Clinical Psychology, School of Psychology, Bangor University, UK.
Alan WatkinsAssociate Professor of e-Trials Research, Medical School, Swansea University, UK.
Ian T RussellProfessor of Clinical Trials, Medical School, Swansea University, UK.
University of Southampton · GBDorset HealthCare University NHS Foundation Trust · GBKing's College London · GBSwansea University · GBBangor University · GBSouthern Health NHS Foundation Trust · GBUniversity of Essex · GBUniversity of Exeter · GBUniversity of Plymouth · GB

Funding

Medical Research Council
6 · The paper itself

Abstract

backgroundIndividuals 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.

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

methodRO 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.

resultsAfter 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.

conclusionsThe 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.

Indexed as

Dialectical Behavior TherapyOutcome Assessment, Health CarePsychotherapeutic ProcessesAdultDepressive Disorder, Treatment-ResistantFemaleFollow-Up StudiesHumansMajor Depressive DisorderMaleMiddle AgedPsychiatric Status Rating ScalesSecondary Health Carechronic depressionpersonality disorderradically open dialectical behaviour therapy (RO DBT)randomised controlled trialTreatment-resistant depression

Identifiers

PMID31317843
PMCPMC7282863
OpenAlexW2963243720

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.