MemFlex to Prevent Depressive Relapse

May 25, 2021 updated by: Medical Research Council Cognition and Brain Sciences Unit

A Randomised Controlled Trial of the Efficacy of Autobiographical Memory Flexibility (MemFlex) Training in Preventing Relapse of Recurrent Depression

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom, CB2 7EF
        • MRC Cognition and Brain Sciences Unit
      • Cambridge, United Kingdom
        • Cambridge and Peterborough NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Memory Flexibility (MemFlex) Training
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
As in experimental arm description
Other Names:
  • MemFlex
Placebo Comparator: Psychoeducation
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
As in experimental arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to depressive relapse
Time Frame: 12 months post-intervention
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
Time Frame: 12 months post-intervention
Number of depression free days as indexed by the Longitudinal Interval Follow-up Evaluation (Keller et al., 1987)
12 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive status at 12 month follow-up
Time Frame: 12 months post-intervention
Presence of a Major Depressive Episode as indexed by the Longitudinal Interval Follow-up Evaluation (Keller et al., 1987)
12 months post-intervention
Depression symptoms at 12 month follow-up
Time Frame: 12 months post-intervention
Score on the Beck Depression Inventory
12 months post-intervention
Autobiographical memory retrieval
Time Frame: Measured within one week of completing the intervention
Scores for specific and alternating blocks of the alternating instructions autobiographical memory task (Dritschel et al., 2013)
Measured within one week of completing the intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rumination
Time Frame: Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention
Total and sub-scale scores on the Rumination Response Scale (Treynor, Gonzalez, Nolen-Hoeksema, 2003)
Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention
Problem solving
Time Frame: Measured within one week of completing the intervention, and six months post-intervention
The total number of means and total effectiveness scores on the abbreviated version of the Means-Ends Problem Solving task (Marx, Williams, & Claridge, 1992)
Measured within one week of completing the intervention, and six months post-intervention
Cognitive avoidance
Time Frame: Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention
Total score on the Cognitive Avoidance Questionnaire (Sexton & Dugas, 2008)
Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention
Anxiety symptoms
Time Frame: Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention
Total score on the Beck Anxiety Inventory (Beck & Steer, 1993)
Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention
Hopelessness
Time Frame: Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention
Total score on the Beck Hopelessness Scale (Beck, Weissman, Lester, & Trexler, 1974)
Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Research Council Cognition and Brain Sciences Unit

Investigators

  • Principal Investigator: Tim Dalgleish, Medical Research Council Cognition and Brain Sciences Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

November 19, 2015

First Submitted That Met QC Criteria

November 24, 2015

First Posted (Estimate)

November 25, 2015

Study Record Updates

Last Update Posted (Actual)

May 26, 2021

Last Update Submitted That Met QC Criteria

May 25, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MemFlex to prevent relapse

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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