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Study protocol for a randomised, controlled platform trial estimating the effect of autobiographical Memory Flexibility training (MemFlex) on relapse of recurrent major depressive disorder.

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dc.creator Hitchcock, Caitlin
dc.creator Gormley, Siobhan
dc.creator O'Leary, Cliodhna
dc.creator Rodrigues, Evangeline
dc.creator Wright, Isobel
dc.creator Griffiths, Kirsty
dc.creator Gillard, Julia
dc.creator Watson, Peter
dc.creator Hammond, Emily
dc.creator Werner-Seidler, Aliza
dc.creator Dalgleish, Timothy
dc.date 2018-02-16T13:11:19Z
dc.date 2018-02-16T13:11:19Z
dc.date 2018-01-29
dc.date.accessioned 2019-03-20T08:23:08Z
dc.date.available 2019-03-20T08:23:08Z
dc.identifier https://www.repository.cam.ac.uk/handle/1810/273286
dc.identifier 10.17863/CAM.20309
dc.identifier.uri https://evidence.thinkportal.org/handle/123456789/32237
dc.description INTRODUCTION: Major depressive disorder (MDD) is a chronic condition. Although current treatment approaches are effective in reducing acute depressive symptoms, rates of relapse are high. Chronic and inflexible retrieval of autobiographical memories, and in particular a bias towards negative and overgeneral memories, is a reliable predictor of relapse. This randomised controlled single-blind trial will determine whether a therapist-guided self-help intervention to ameliorate autobiographical memory biases using Memory Flexibility training (MemFlex) will increase the experience of depression-free days, relative to a psychoeducation control condition, in the 12 months following intervention. METHODS AND ANALYSIS: Individuals (aged 18 and above) with a diagnosis of recurrent MDD will be recruited when remitted from a major depressive episode. Participants will be randomly allocated to complete 4 weeks of a workbook providing either MemFlex training, or psychoeducation on factors that increase risk of relapse. Assessment of diagnostic status, self-report depressive symptoms, depression-free days and cognitive risk factors for depression will be completed post-intervention, and at 6 and 12 months follow-up. The cognitive target of MemFlex will be change in memory flexibility on the Autobiographical Memory Test- Alternating Instructions. The primary clinical endpoints will be the number of depression-free days in the 12 months following workbook completion, and time to depressive relapse. ETHICS AND DISSEMINATION: Ethics approval has been granted by the NHS National Research Ethics Committee (East of England, 11/H0305/1). Results from this study will provide a point-estimate of the effect of MemFlex on depressive relapse, which will be used to inform a fully powered trial evaluating the potential of MemFlex as an effective, low-cost and low-intensity option for reducing relapse of MDD. TRIAL REGISTRATION NUMBER: NCT02614326.
dc.description This work is supported by a grant to TD from the UK Medical Research Council, grant number MC_US_A060_0019.
dc.language eng
dc.language en
dc.publisher BMJ
dc.publisher BMJ Open
dc.rights Attribution 4.0 International
dc.rights http://creativecommons.org/licenses/by/4.0/
dc.subject adult psychiatry
dc.subject clinical trials
dc.title Study protocol for a randomised, controlled platform trial estimating the effect of autobiographical Memory Flexibility training (MemFlex) on relapse of recurrent major depressive disorder.
dc.type Article


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