Clinical trial NCT02614326: MemFlex to Prevent Depressive Relapse
Official title: A Randomised Controlled Trial of the Efficacy of Autobiographical Memory Flexibility (MemFlex) Training in Preventing Relapse of Recurrent Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Depression
Cognitive risk factors
Autobiographical memory
Cognitive bias
Relapse prevention
Lead sponsor: Medical Research Council Cognition and Brain Sciences Unit
Sponsor class: OTHER_GOV
First posted: 2015-11-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A wealth of research has demonstrated that they way in which the investigators recall our personal, autobiographical memories is influential in the course of depression. Biases in the recall of autobiographical memory occur in the midst of a depressive episode, and are shown to prolong symptoms, however these biases also remain when depression remits, and may predispose the individual towards relapse. A novel cognitive intervention, MemFlex, aims to train individuals to be flexible in their retrieval of autobiographical memories, and thereby reduce depressive relapse. Changes in memory bias may also have an effect on intermediate processes that increase risk of depression, such as rumination, impaired problem solving, and cognitive avoidance. This feasibility trial compares the effects of MemFlex and Psychoeducation in their ability to reduce memory bias and intermediate cognitive risk factors, and thereby depressive relapse, in individuals remitted from Major Depressive Disorder. Clinical outcome and process measures will be assessed immediately following completion of the intervention, at 6 months post-intervention, and at 12 months post-intervention. If encouraging, the results of this pilot trial may provide a foundation for a later phase trial.


Eligibility criteria: Inclusion Criteria:

* Meets criteria for Major Depressive Disorder but is currently in remission, indexed on the Structured Clinical Interview for the DSM (SCID; First et al., 1996)
* 18 years of age or older

Exclusion Criteria:

* Meets criteria for a current Major Depressive Episode, indexed on the SCID
* Meets criteria for another mood disorder (e.g., Bipolar disorder), indexed on the SCID
* Current alcohol or substance dependence, or currently experiencing psychotic symptoms, indexed on the SCID
* Experience of intellectual disability, traumatic brain injury, or other neurological condition which may impact memory recall, assessed via self-report

Primary outcomes:
measure: Time to depressive relapse
timeFrame: 12 months post-intervention
measure: Number of depression free days at 12 month follow-up
timeFrame: 12 months post-intervention
Secondary outcomes:
measure: Depressive status at 12 month follow-up
timeFrame: 12 months post-intervention
measure: Depression symptoms at 12 month follow-up
timeFrame: 12 months post-intervention
measure: Autobiographical memory retrieval
timeFrame: Measured within one week of completing the intervention
Other outcomes:
measure: Rumination
timeFrame: Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention
measure: Problem solving
timeFrame: Measured within one week of completing the intervention, and six months post-intervention
measure: Cognitive avoidance
timeFrame: Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention
measure: Anxiety symptoms
timeFrame: Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention
measure: Hopelessness
timeFrame: Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention
Locations:
city: Cambridge
country: United Kingdom
facility: MRC Cognition and Brain Sciences Unit
city: Cambridge
country: United Kingdom
facility: Cambridge and Peterborough NHS Foundation Trust
Study officials:
affiliation: Medical Research Council Cognition and Brain Sciences Unit
name: Tim Dalgleish
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beck, A., Steer, R., & Brown, G. (1996). Manual for the Beck Depression Inventory II. San Antonio, TX: Psychological Corporation.
citation: Beck, A. T., & Steer, R. A. (1993). Beck Anxiety Inventory Manual. San Antonio, TX: Psychological Corporation.
citation: Dritschel B, Beltsos S, McClintock SM. An "alternating instructions" version of the Autobiographical Memory Test for assessing autobiographical memory specificity in non-clinical populations. Memory. 2014;22(8):881-9. doi: 10.1080/09658211.2013.839710. Epub 2013 Nov 12.
citation: First, M. B., Spitzer, R. L., Gibbon, M., & Williams, J. B. (2002). Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Research Version, Patient Edition. New York: Biometrics Research, New York State Psychiatric Institute.
citation: Treynor, W., Gonzalez, R., & Nolen-Hoeksema, S. (2003). Rumination reconsidered: A psychometric analysis. Cognitive Therapy and Research, 27, 247-259. doi: 10.1023/A:1023910315561
citation: Marx EM, Williams JM, Claridge GC. Depression and social problem solving. J Abnorm Psychol. 1992 Feb;101(1):78-86. doi: 10.1037//0021-843x.101.1.78.
citation: Sexton KA, Dugas MJ. The Cognitive Avoidance Questionnaire: validation of the English translation. J Anxiety Disord. 2008;22(3):355-70. doi: 10.1016/j.janxdis.2007.04.005. Epub 2007 Apr 25.
citation: Beck AT, Weissman A, Lester D, Trexler L. The measurement of pessimism: the hopelessness scale. J Consult Clin Psychol. 1974 Dec;42(6):861-5. doi: 10.1037/h0037562. No abstract available.
citation: Keller MB, Lavori PW, Friedman B, Nielsen E, Endicott J, McDonald-Scott P, Andreasen NC. The Longitudinal Interval Follow-up Evaluation. A comprehensive method for assessing outcome in prospective longitudinal studies. Arch Gen Psychiatry. 1987 Jun;44(6):540-8. doi: 10.1001/archpsyc.1987.01800180050009.
citation: Hitchcock C, Gormley S, O'Leary C, Rodrigues E, Wright I, Griffiths K, Gillard J, Watson P, Hammond E, Werner-Seidler A, Dalgleish T. Study protocol for a randomised, controlled platform trial estimating the effect of autobiographical Memory Flexibility training (MemFlex) on relapse of recurrent major depressive disorder. BMJ Open. 2018 Jan 29;8(1):e018194. doi: 10.1136/bmjopen-2017-018194.