NCT02614326

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_2 major-depressive-disorder

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_2 major-depressive-disorder

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 26, 2021

Status Verified

May 1, 2021

Enrollment Period

4.6 years

First QC Date

November 19, 2015

Last Update Submit

May 25, 2021

Conditions

Major Depressive Disorder

Keywords

DepressionCognitive risk factorsAutobiographical memoryCognitive biasRelapse prevention

Outcome Measures

Primary Outcomes (2)

  • Time to depressive relapse

    Length of time from post-intervention assessment to occurrence of any major depressive episode within the 12 month follow-up period

    12 months post-intervention

  • Number of depression free days at 12 month follow-up

    Number of depression free days as indexed by the Longitudinal Interval Follow-up Evaluation (Keller et al., 1987)

    12 months post-intervention

Secondary Outcomes (3)

  • Depressive status at 12 month follow-up

    12 months post-intervention

  • Depression symptoms at 12 month follow-up

    12 months post-intervention

  • Autobiographical memory retrieval

    Measured within one week of completing the intervention

Other Outcomes (5)

  • Rumination

    Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention

  • Problem solving

    Measured within one week of completing the intervention, and six months post-intervention

  • Cognitive avoidance

    Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention

  • +2 more other outcomes

Study Arms (2)

Memory Flexibility (MemFlex) Training

EXPERIMENTAL

MemFlex training draws on cognitive bias modification and memory specificity training techniques (Raes et al., 2009; Dalgleish et al., 2014). MemFlex is primarily self-guided and aims to reduce autobiographical memory biases associated with depression. The training is presented over one face-to-face session and eight self-guided sessions. In the initial session, the researcher introduces cued-recall tasks used throughout the workbook, and guides the participant in completion of the tasks. When understanding of the basic principles is satisfactory, the researcher assists the participant to set a schedule for completion of the workbook over the following four weeks. The participant will receive a phone call at the beginning of week three to check progress, and clarify any difficulties.

Behavioral: Autobiographical Memory Flexibility (MemFlex) training

Psychoeducation

PLACEBO COMPARATOR

The psychoeducation condition will also complete an initial face-to-face session. This session will cover the symptoms and causes of depression, and the workbook will be introduced. The workbook will consist of eight self-guided sessions that the individual will be required to complete over four weeks. The workbook content will cover the presentation of depression and basic information on factors associated with depression, such as worry, procrastination, and sleep difficulties. Each session consists of psychological theories of the topic, followed by a series of questions about the material to ensure participant engagement. The participant will receive a phone call from a team member at the beginning of week three to check progress, and clarify any difficulties.

Behavioral: Psychoeducation

Interventions

Autobiographical Memory Flexibility (MemFlex) trainingBEHAVIORAL

As in experimental arm description

Also known as: MemFlex
Memory Flexibility (MemFlex) Training
PsychoeducationBEHAVIORAL

As in experimental arm description

Psychoeducation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • years of age or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MRC Cognition and Brain Sciences Unit

Cambridge, CB2 7EF, United Kingdom

Location

Cambridge and Peterborough NHS Foundation Trust

Cambridge, United Kingdom

Location

Related Publications (10)

  • Beck, A., Steer, R., & Brown, G. (1996). Manual for the Beck Depression Inventory II. San Antonio, TX: Psychological Corporation.

    BACKGROUND

  • Beck, A. T., & Steer, R. A. (1993). Beck Anxiety Inventory Manual. San Antonio, TX: Psychological Corporation.

    BACKGROUND

  • 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.

    PMID: 24215524BACKGROUND

  • 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.

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 1537977BACKGROUND

  • 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.

    PMID: 17544253BACKGROUND

  • 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.

    PMID: 4436473BACKGROUND

  • 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.

    PMID: 3579500BACKGROUND

  • 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.

    PMID: 29382674DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Tim Dalgleish

    Medical Research Council Cognition and Brain Sciences Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2015

First Posted

November 25, 2015

Study Start

January 1, 2016

Primary Completion

August 1, 2020

Study Completion

December 1, 2020

Last Updated

May 26, 2021

Record last verified: 2021-05

Locations

GB(2)