NCT02371291

Brief Summary

Our collection of memories for personal experiences plays an important role in shaping our sense of who we are as people. These memories, termed autobiographical memories, can also be helpful in social situations, for sharing the details of our experiences with other people, reminiscing about pleasant times and solving problems by remembering what has and hasn't worked in the past. Different types of autobiographical memory are helpful to us depending on the particular situation the investigators are in at the time. Recent research has shown that experiencing depressed mood can affect how we relate to our autobiographical memories, so that instead of providing a rich source of personal information in a helpful and flexible way, the types of memories that come to mind are more narrowly focused on difficult or negative experiences. This can cause low mood to persist over time. The purpose of this study is to test a newly-developed therapeutic training package for depressed mood (MemFlex), designed to encourage helpful and flexible ways of relating to autobiographical memories. The MemFlex programme consists of a one-to-one orientation session with the researcher to introduce the training package, followed by a workbook that is completed at home.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_1 major-depressive-disorder

Timeline
Completed

Started Jan 2015

Typical duration for phase_1 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

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

1.9 years

First QC Date

February 9, 2015

Last Update Submit

September 7, 2017

Conditions

Keywords

Memory Flexibility

Outcome Measures

Primary Outcomes (2)

  • Depressive Status

    Three months after completion of the workbook

  • Change in score on the Beck Depression Inventory (Beck, Steer, & Brown, 1996) from baseline

    Self report measure of depression symptoms

    Three months after completion of the workbook

Secondary Outcomes (2)

  • Depression free days

    Three months after completion of the workbook

  • Change in memory flexibility from baseline, Score on the alternating instructions autobiographical memory task (Dritschel et al., 2013)

    Three months after completion of the workbook

Other Outcomes (6)

  • Change in Rumination as measured by Rumination Response Scale

    4-6 weeks after beginning the workbook

  • Change in Cognitive Avoidance, as measured by Cognitive Avoidance Questionnaire

    4-6 weeks after beginning the workbook

  • Change in Verbal Fluency as measured by the Verbal Fluency Task

    4-6 weeks after beginning the workbook

  • +3 more other outcomes

Study Arms (2)

Memory Flexibility Training

EXPERIMENTAL

The MemFlex programme draws on cognitive bias modification and memory specificity training techniques (Raes et al., 2009; Dalgleish et al., 2014), and was developed by clinical psychologists. MemFlex is primarily self-guided and aims to reduce autobiographical memory biases associated with depression. The training material is presented over one face-to-face session and eight self-guided sessions. In the initial session, the researcher introduces cued-recall tasks which are used throughout the workbook, and guides the participant in completion of these 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 weekly emails during this period, encouraging them to complete the workbook. They will also receive a phone call from a team member at the beginning of week three to check progress.

Behavioral: Memory Flexibility 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. As in the MemFlex condition, the workbook will consist of eight self-guided sessions that the individual will be required to complete over four weeks. The participant will receive weekly emails during this period, encouraging them to complete the workbook. They will also receive a phone call from a team member at the beginning of week three to check progress, and clarify any difficulties with the workbook material. 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 information on psychological theories of the topic, followed by a series of questions about the material to ensure participant engagement. The workbook was developed by clinical psychologists.

Behavioral: Psychoeducation

Interventions

As in experimental arm description.

Memory Flexibility 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:

  • Currently experiencing Major Depressive Episode, indexed on the Structured Clinical Interview for the DSM-IV (SCID; First et al., 1996).
  • Score of 13 or above on the Beck Depression Inventory (Beck et al., 1996)

You may not qualify if:

  • SCID assessment indicates they are experiencing another mood disorder, psychosis, current alcohol or substance dependence/abuse.
  • Diagnosed Axis II disorder or brain injury (assessed by participant 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 (6)

  • 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 Mar;40(1):24-38. doi: 10.1016/j.jbtep.2008.03.001. Epub 2008 Mar 12.

    PMID: 18407245BACKGROUND
  • Dalgleish T, Bevan A, McKinnon A, Breakwell L, Mueller V, Chadwick I, Schweizer S, Hitchcock C, Watson P, Raes F, Jobson L, Werner-Seidler A. 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 Jul 22;15:293. doi: 10.1186/1745-6215-15-293.

    PMID: 25052061BACKGROUND
  • Beck, A., Steer, R., & Brown, G. (1996). Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation.

    BACKGROUND
  • First, M., Spitzer, R., Gibbons, M., & Williams, J. (1996). Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-IV). Washington, DC: American Psychiatric Press.

    BACKGROUND
  • Hitchcock C, Gormley S, Rees C, Rodrigues E, Gillard J, Panesar I, Wright IM, Hammond E, Watson P, Werner-Seidler A, Dalgleish T. A randomised controlled trial of memory flexibility training (MemFlex) to enhance memory flexibility and reduce depressive symptomatology in individuals with major depressive disorder. Behav Res Ther. 2018 Nov;110:22-30. doi: 10.1016/j.brat.2018.08.008. Epub 2018 Aug 29.

  • Hitchcock C, Hammond E, Rees C, Panesar I, Watson P, Werner-Seidler A, Dalgleish T. Memory Flexibility training (MemFlex) to reduce depressive symptomatology in individuals with major depressive disorder: study protocol for a randomised controlled trial. Trials. 2015 Nov 3;16:494. doi: 10.1186/s13063-015-1029-y.

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Tim Dalgleish, PhD

    MRC Cognition and Brain Sciences Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 25, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

September 11, 2017

Record last verified: 2017-09

Locations