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

Caitlin Hitchcock, Siobhan Gormley, Cliodhna O'Leary, Evangeline Rodrigues, Isobel Wright, Kirsty Griffiths, Julia Gillard, Peter Watson, Emily Hammond, Aliza Werner-Seidler, Tim Dalgleish, Caitlin Hitchcock, Siobhan Gormley, Cliodhna O'Leary, Evangeline Rodrigues, Isobel Wright, Kirsty Griffiths, Julia Gillard, Peter Watson, Emily Hammond, Aliza Werner-Seidler, Tim Dalgleish

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.

Keywords: adult psychiatry; clinical trials.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Flow chart of study design (Consolidated Standards of Reporting Trials diagram). All outcome and process measures will be completed at all time points. MemFlex, Memory Flexibility training.

References

    1. McCrone P, Dhanasiri S, Patel A, et al. . Paying the price. The cost of mental health care in England to 2026. London: King’s Fund, 2008.
    1. Butler AC, Chapman JE, Forman EM, et al. . The empirical status of cognitive-behavioral therapy: a review of meta-analyses. Clin Psychol Rev 2006;26:17–31. 10.1016/j.cpr.2005.07.003
    1. Judd LL. The clinical course of unipolar major depressive disorders. Arch Gen Psychiatry 1997;54:989–91. 10.1001/archpsyc.1997.01830230015002
    1. Kessing LV. Severity of depressive episodes during the course of depressive disorder. Br J Psychiatry 2008;192:290–3. 10.1192/bjp.bp.107.038935
    1. Burcusa SL, Iacono WG. Risk for recurrence in depression. Clin Psychol Rev 2007;27:959–85. 10.1016/j.cpr.2007.02.005
    1. Conway MA, Pleydell-Pearce CW. The construction of autobiographical memories in the self-memory system. Psychol Rev 2000;107:261–88. 10.1037/0033-295X.107.2.261
    1. Dalgleish T, Werner-Seidler A. Disruptions in autobiographical memory processing in depression and the emergence of memory therapeutics. Trends Cogn Sci 2014;18:596–604. 10.1016/j.tics.2014.06.010
    1. Dritschel B, Beltsos S, McClintock SM, et al. . An “alternating instructions” version of the Autobiographical Memory Test for assessing autobiographical memory specificity in non-clinical populations. Memory 2014;22:881–9. 10.1080/09658211.2013.839710
    1. Hitchcock C, Gormley S, Rees C, et al. . The translational development of Memory Flexibility training (MemFlex) to enhance memory flexibility and reduce depressive symptomatology in individuals with Major Depressive Disorder. Under review.
    1. Dalgleish T, Bevan A, McKinnon A, et al. . A comparison of MEmory Specificity Training (MEST) to education and support (ES) in the treatment of recurrent depression: study protocol for a cluster randomised controlled trial. Trials 2014;15:293–302. 10.1186/1745-6215-15-293
    1. Williams JM, Barnhofer T, Crane C, et al. . Autobiographical memory specificity and emotional disorder. Psychol Bull 2007;133:122–48. 10.1037/0033-2909.133.1.122
    1. Goddard L, Dritschel B, Burton A. Role of autobiographical memory in social problem solving and depression. J Abnorm Psychol 1996;105:609–16. 10.1037/0021-843X.105.4.609
    1. Klein SB, Cosmides L, Tooby J, et al. . Decisions and the evolution of memory: multiple systems, multiple functions. Psychol Rev 2002;109:306–29. 10.1037/0033-295X.109.2.306
    1. Klein SB, Cosmides L, Tooby J, et al. . Priming exceptions: a test of the scope hypothesis in naturalistic trait judgments. Soc Cogn 2001;19:443–68. 10.1521/soco.19.4.443.20757
    1. Hipwell AE, Sapotichne B, Klostermann S, et al. . Autobiographical memory as a predictor of depression vulnerability in girls. J Clin Child Adolesc Psychol 2011;40:254–65. 10.1080/15374416.2011.546037
    1. Sumner JA, Griffith JW, Mineka S. Overgeneral autobiographical memory as a predictor of the course of depression: a meta-analysis. Behav Res Ther 2010;48:614–25. 10.1016/j.brat.2010.03.013
    1. Gotlib IH, Joormann J. Cognition and depression: current status and future directions. Annu Rev Clin Psychol 2010;6:285–312. 10.1146/annurev.clinpsy.121208.131305
    1. Werner-Seidler A, Moulds ML. Autobiographical memory characteristics in depression vulnerability: formerly depressed individuals recall less vivid positive memories. Cogn Emot 2011;25:1087–103. 10.1080/02699931.2010.531007
    1. Joormann J, Siemer M. Memory accessibility, mood regulation, and dysphoria: difficulties in repairing sad mood with happy memories? J Abnorm Psychol 2004;113:179–88. 10.1037/0021-843X.113.2.179
    1. Teasdale JD, Dent J. Cognitive vulnerability to depression: an investigation of two hypotheses. Br J Clin Psychol 1987;26(Pt 2):113–26. 10.1111/j.2044-8260.1987.tb00737.x
    1. Beck AT. Depression: clinical, experimental, and theoretical aspects. Hoeber Medical Division, Harper & Row, 1967.
    1. Williams JM, Teasdale JD, Segal ZV, et al. . Mindfulness-based cognitive therapy reduces overgeneral autobiographical memory in formerly depressed patients. J Abnorm Psychol 2000;109:150–5. 10.1037/0021-843X.109.1.150
    1. Watkins ER, Taylor RS, Byng R, et al. . Guided self-help concreteness training as an intervention for major depression in primary care: a Phase II randomized controlled trial. Psychol Med 2012;42:1359–71. 10.1017/S0033291711002480
    1. Nolen-Hoeksema S. Responses to depression and their effects on the duration of depressive episodes. J Abnorm Psychol 1991;100:569–82. 10.1037/0021-843X.100.4.569
    1. Beike DR, Brandon NR, Cole HE. Is sharing specific autobiographical memories a distinct form of self-disclosure? J Exp Psychol Gen 2016;145:434–50. 10.1037/xge0000143
    1. Jing HG, Madore KP, Schacter DL. Worrying about the future: An episodic specificity induction impacts problem solving, reappraisal, and well-being. J Exp Psychol Gen 2016;145:402–18. 10.1037/xge0000142
    1. Hitchcock C, Rees C, Dalgleish T. The devil’s in the detail: accessibility of specific personal memories supports rose-tinted self-generalizations in mental health and toxic self-generalizations in clinical depression. J Exp Psychol Gen 2017;146:1286–95. 10.1037/xge0000343
    1. Sumner JA, Griffith JW, Mineka S, et al. . Overgeneral autobiographical memory and chronic interpersonal stress as predictors of the course of depression in adolescents. Cogn Emot 2011;25:183–92. 10.1080/02699931003741566
    1. Neshat-Doost HT, Dalgleish T, Yule W, et al. . Enhancing autobiographical memory specificity through cognitive training: an intervention for depression translated from basic science. Clin Psychol Sci 2013;1:84–92. 10.1177/2167702612454613
    1. Raes F, Williams JM, Hermans D. Reducing cognitive vulnerability to depression: a preliminary investigation of MEmory Specificity Training (MEST) in inpatients with depressive symptomatology. J Behav Ther Exp Psychiatry 2009;40:24–38. 10.1016/j.jbtep.2008.03.001
    1. Hitchcock C, Werner-Seidler A, Blackwell SE, et al. . Autobiographical episodic memory-based training for the treatment of mood, anxiety and stress-related disorders: a systematic review and meta-analysis. Clin Psychol Rev 2017;52:92–107. 10.1016/j.cpr.2016.12.003
    1. Nolen-Hoeksema S, Wisco BE, Lyubomirsky S, et al. . Rethinking rumination. Perspect Psychol Sci 2008;3:400–24. 10.1111/j.1745-6924.2008.00088.x
    1. Taylor SE, Brown JD. Illusion and well-being: a social psychological perspective on mental health. Psychol Bull 1988;103:193–210. 10.1037/0033-2909.103.2.193
    1. Hitchcock C, Mueller V, Hammond E, et al. . The effects of autobiographical memory flexibility (MemFlex) training: An uncontrolled trial in individuals in remission from depression. J Behav Ther Exp Psychiatry 2016;52:92–8. 10.1016/j.jbtep.2016.03.012
    1. Hitchcock C, Hammond E, Rees C, et al. . Memory Flexibility training (MemFlex) to reduce depressive symptomatology in individuals with major depressive disorder: study protocol for a randomised controlled trial. Trials 2015;16:1–8. 10.1186/s13063-015-1029-y
    1. Medical Research Council. A framework for development and evaluation of rcts for complex interventions to improve health. London: Medical Research Council, 2000.
    1. First M, Williams JBW, Karg RS, et al. . Structured clinical interview for DSM-V disorders (SCID-V). Arlington, VA: American Psychiatric Association, 2015.
    1. Keller MB, Lavori PW, Friedman B, et al. . The longitudinal interval follow-up evaluation. a comprehensive method for assessing outcome in prospective longitudinal studies. Arch Gen Psychiatry 1987;44:540–8.
    1. Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry 2000;31:73–86. 10.1016/S0005-7916(00)00012-4
    1. Beck AT, Steer R, Brown G. Manual for the beck depression inventory-II. San Antonio, TX: Psychological Corporation, 1996.
    1. Treynor W. Rumination reconsidered: a psychometric analysis. Cognit Ther Res 2003;27:247–59. 10.1023/A:1023910315561
    1. Sexton KA, Dugas MJ. The cognitive avoidance questionnaire: validation of the English translation. J Anxiety Disord 2008;22:355–70. 10.1016/j.janxdis.2007.04.005
    1. Lyubomirsky S, Nolen-Hoeksema S. Effects of self-focused rumination on negative thinking and interpersonal problem solving. J Pers Soc Psychol 1995;69:176–90. 10.1037/0022-3514.69.1.176
    1. Tombaugh TN, Kozak J, Rees L. Normative data stratified by age and education for two measures of verbal fluency: FAS and animal naming. Arch Clin Neuropsychol 1999;14:167–77.
    1. Travers-Hill E, Dunn BD, Hoppitt L, et al. . Beneficial effects of training in self-distancing and perspective broadening for people with a history of recurrent depression. Behav Res Ther 2017;95:19–28. 10.1016/j.brat.2017.05.008
    1. Bodner TE. What improves with increased missing data imputations? Struct Equ Modeling 2008;15:651–75. 10.1080/10705510802339072
    1. Mathers C, Fat DM, Boerma JT. The global burden of disease: 2004 update. World Health Organization, 2008.
    1. Health PM. Concepts emerging evidence and practice. Summary report. Geneva: World Health Organisation, 2004.

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel