title: Memory Flexibility training (MemFlex) to reduce depressive symptomatology in individuals with major depressive disorder: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Major depressive disorder (MDD) is associated with chronic biases in the allocation of attention and recollection of personal memories. Impaired flexibility in attention and autobiographical memory retrieval is seen to both maintain current symptoms and predict future depression. Development of innovative interventions to reduce maladaptive cognitive patterns and improve cognitive flexibility in the domain of memory may therefore advance current treatment approaches for depression. Memory specificity training and cognitive bias modification techniques have both shown some promise in improving cognitive flexibility. Here we outline plans for a trial of an innovative memory flexibility training programme, MemFlex, which advances current training techniques with the aim of improving flexibility of autobiographical memory retrieval. This trial seeks to estimate the efficacy of MemFlex, provide data on feasibility, and begin to explore mechanisms of change.
  
  
  METHODS
  We plan a single-blind, randomised, controlled, patient-level trial in which 50 individuals with MDD will complete either psychoeducation (n = 25) or MemFlex (n = 25). After completing pre-treatment measures and an orientation session, participants complete eight workbook-based sessions at home. Participants will then be assessed at post-treatment and at 3 month follow-up. The co-primary outcomes are depressive symptoms and diagnostic status at 3 month follow-up. The secondary outcomes are memory flexibility at post-treatment and number of depression free days at 3 month follow-up. Other process outcomes and mediators of any treatment effects will also be explored.
  
  
  CONCLUSIONS
  This trial will establish the efficacy of MemFlex in improving memory flexibility, and reducing depressive symptoms. Any effects on process measures related to relapse may also indicate whether MemFlex may be helpful in reducing vulnerability to future depressive episodes. The low-intensity and workbook-based format of the programme may improve access to psychological therapies, and, if encouraging, the results of this study will provide a platform for later-phase trials.
  
  
  BACKGROUND
  NCT02371291 (ClinicalTrials.gov), registered 9 February 2015.
authors.affiliation: Medical Research Council Cognition and Brain Sciences Unit, Cambridge, UK. Caitlin.hitchcock@mrc-cbu.cam.ac.uk.|Cambridgeshire and Peterborough National Health Service Foundation Trust (CPFT), Cambridge, UK. Caitlin.hitchcock@mrc-cbu.cam.ac.uk.
authors.forename: Caitlin
authors.initials: C
authors.lastname: Hitchcock
authors.affiliation: Medical Research Council Cognition and Brain Sciences Unit, Cambridge, UK. E.R.Hammond@exeter.ac.uk.|University of Exeter, Exeter, Devon, UK. E.R.Hammond@exeter.ac.uk.
authors.forename: Emily
authors.initials: E
authors.lastname: Hammond
authors.affiliation: Medical Research Council Cognition and Brain Sciences Unit, Cambridge, UK. ReesC25@cardiff.ac.uk.
authors.forename: Catrin
authors.initials: C
authors.lastname: Rees
authors.affiliation: Medical Research Council Cognition and Brain Sciences Unit, Cambridge, UK. Inderpal.Panesar@cpft.nhs.uk.|Cambridgeshire and Peterborough National Health Service Foundation Trust (CPFT), Cambridge, UK. Inderpal.Panesar@cpft.nhs.uk.
authors.forename: Inderpal
authors.initials: I
authors.lastname: Panesar
authors.affiliation: Medical Research Council Cognition and Brain Sciences Unit, Cambridge, UK. Peter.watson@mrc-cbu.cam.ac.uk.
authors.forename: Peter
authors.initials: P
authors.lastname: Watson
authors.affiliation: Medical Research Council Cognition and Brain Sciences Unit, Cambridge, UK. a.werner-seidler@blackdog.org.au.|The Black Dog Institute, Prince of Wales Hospital, Randwick, NSW, Australia. a.werner-seidler@blackdog.org.au.
authors.forename: Aliza
authors.initials: A
authors.lastname: Werner-Seidler
authors.affiliation: Medical Research Council Cognition and Brain Sciences Unit, Cambridge, UK. tim.dalgleish@mrc-cbu.cam.ac.uk.|Cambridgeshire and Peterborough National Health Service Foundation Trust (CPFT), Cambridge, UK. tim.dalgleish@mrc-cbu.cam.ac.uk.
authors.forename: Tim
authors.initials: T
authors.lastname: Dalgleish
mesh_terms: D001288:Attention; D002985:Clinical Protocols; D003071:Cognition; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000517:prevention & control* / Q000523:psychology; D004739:England; D005240:Feasibility Studies; D006801:Humans; D061212:Memory, Episodic; D011569:Psychiatric Status Rating Scales; D011613:Psychotherapy / Q000379:methods*; D012107:Research Design; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome