MemFlex to Prevent Depressive Relapse

Study Overview
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Brief Summary
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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.

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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Autobiographical Memory Flexibility (MemFlex) training
* Behavioral: Psychoeducation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Memory Flexibility (MemFlex) Training<br>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<br>* As in experimental arm description<br>* Other names: MemFlex;|
| Placebo Comparator: Psychoeducation<br>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<br>* As in experimental arm description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 12 months post-intervention | 
| Depression symptoms at 12 month follow-up | Score on the Beck Depression Inventory | 12 months post-intervention | 
| Autobiographical memory retrieval | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Cognitive risk factors, Autobiographical memory, Cognitive bias, Relapse prevention