MemFlex to Prevent Depressive Relapse

Phase 2

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT02614326
• Lead Sponsor: Medical Research Council Cognition and Brain Sciences Unit

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-19
• Study First Submitted QC: 2015-11-24
• Study First Posted: 2015-11-25
• Study Start: 2016-01
• Primary Completion: 2020-08
• Study Completion: 2020-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-25
• Last Update Posted: 2021-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of depression free days at 12 month follow-up	12 months post-intervention	Number of depression free days as indexed by the Longitudinal Interval Follow-up Evaluation (Keller et al., 1987)
Time to depressive relapse	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

Secondary Outcome Measures

Name	Time	Method
Depressive status at 12 month follow-up	12 months post-intervention	Presence of a Major Depressive Episode as indexed by the Longitudinal Interval Follow-up Evaluation (Keller et al., 1987)
Depression symptoms at 12 month follow-up	12 months post-intervention	Score on the Beck Depression Inventory
Autobiographical memory retrieval	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)

Trial Locations

Locations (2)

MRC Cognition and Brain Sciences Unit; 🇬🇧 Cambridge, United Kingdom

Cambridge and Peterborough NHS Foundation Trust; 🇬🇧 Cambridge, United Kingdom