Study protocol for a randomised, controlled platform trial estimating the effect of autobiographical Memory Flexibility training (MemFlex) on relapse of recurrent major depressive disorder. Issue 1 (29th January 2018)

• Record Type: Journal Article
• Authors: Hitchcock, Caitlin; Gormley, Siobhan; O'Leary, Cliodhna; Rodrigues, Evangeline; Wright, Isobel; Griffiths, Kirsty; Gillard, Julia; Watson, Peter; Hammond, Emily; Werner-Seidler, Aliza; Dalgleish, Tim
• Is Part Of: BMJ open. Volume 8:Issue 1(2018)
• Publication Date: 2018-01-29
• Subjects: clinical trials -- adult psychiatry; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2017-018194
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : 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 .