ORCID
- Whalley, Ben: 0000-0002-8994-6091
Abstract
IntroductionOnly 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 analysisREFRAMED 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 disseminationThe 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 numberISRCTN85784627.
DOI
10.1136/bmjopen-2015-008857
Publication Date
2015-07-01
Publication Title
BMJ Open
Volume
5
Issue
7
ISSN
2044-6055
Organisational Unit
School of Psychology
First Page
e008857
Last Page
e008857
Recommended Citation
Lynch, T. R., Whalley, B., Hempel, R., Byford, S., Clarke, P., Clarke, S., Kingdon, D., O'Mahen, H., Russell, I., 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), pp. e008857-e008857. Available at: https://doi.org/10.1136/bmjopen-2015-008857
