A Phase 2 interventional study of Autobiographical Memory Flexibility (MemFlex) training and Psychoeducation in Major Depressive Disorder, sponsored by Medical Research Council Cognition and Brain Sciences Unit. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-26.
Sponsored by Medical Research Council Cognition and Brain Sciences Unit · Phase 2, Interventional, and Prevention
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.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's planned enrollment of 70 is below the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Medical Research Council Cognition and Brain Sciences Unit is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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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
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
Also known as: MemFlex
As in experimental arm description
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
Time frame: 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)
Time frame: 12 months post-intervention
Depressive status at 12 month follow-up
Presence of a Major Depressive Episode as indexed by the Longitudinal Interval Follow-up Evaluation (Keller et al., 1987)
Time frame: 12 months post-intervention
Depression symptoms at 12 month follow-up
Score on the Beck Depression Inventory
Time frame: 12 months post-intervention
Autobiographical memory retrieval
Scores for specific and alternating blocks of the alternating instructions autobiographical memory task (Dritschel et al., 2013)
Time frame: Measured within one week of completing the intervention
Rumination
Total and sub-scale scores on the Rumination Response Scale (Treynor, Gonzalez, Nolen-Hoeksema, 2003)
Time frame: Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention
Problem solving
The total number of means and total effectiveness scores on the abbreviated version of the Means-Ends Problem Solving task (Marx, Williams, \& Claridge, 1992)
Time frame: Measured within one week of completing the intervention, and six months post-intervention
Cognitive avoidance
Total score on the Cognitive Avoidance Questionnaire (Sexton \& Dugas, 2008)
Time frame: Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention
Anxiety symptoms
Total score on the Beck Anxiety Inventory (Beck \& Steer, 1993)
Time frame: Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention
Hopelessness
Total score on the Beck Hopelessness Scale (Beck, Weissman, Lester, \& Trexler, 1974)
Time frame: Measured within one week of completing the intervention, six months post-intervention and 12 months post-intervention
The record gives a start of Jan 2016, a primary completion of Aug 2020 and a completion of Dec 2020. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Medical Research Council Cognition and Brain Sciences Unit