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Completed

NCT Number: NCT02614326

MemFlex to Prevent Depressive Relapse

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cambridge and Peterborough NHS Foundation Trust, Cambridge, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autobiographical Memory Flexibility (MemFlex) training

Behavioral

As in experimental arm description

Other names: MemFlex

Psychoeducation

Behavioral

As in experimental arm description

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. 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)

  2. Depression symptoms at 12 month follow-up

    Time frame: 12 months post-intervention

    Score on the Beck Depression Inventory

  3. 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)

Other outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

Medical Research Council Cognition and Brain Sciences Unit

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Nov 25, 2015
Registry last updated
May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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