Overview

This trial is active, not recruiting.

Condition major depressive disorder
Treatments memory flexibility training, psychoeducation
Phase phase 1/phase 2
Sponsor Medical Research Council Cognition and Brain Sciences Unit
Start date January 2015
End date December 2016
Trial size 60 participants
Trial identifier NCT02371291, Mrccbu

Summary

Our collection of memories for personal experiences plays an important role in shaping our sense of who we are as people. These memories, termed autobiographical memories, can also be helpful in social situations, for sharing the details of our experiences with other people, reminiscing about pleasant times and solving problems by remembering what has and hasn't worked in the past. Different types of autobiographical memory are helpful to us depending on the particular situation the investigators are in at the time. Recent research has shown that experiencing depressed mood can affect how we relate to our autobiographical memories, so that instead of providing a rich source of personal information in a helpful and flexible way, the types of memories that come to mind are more narrowly focused on difficult or negative experiences. This can cause low mood to persist over time.

The purpose of this study is to test a newly-developed therapeutic training package for depressed mood (MemFlex), designed to encourage helpful and flexible ways of relating to autobiographical memories. The MemFlex programme consists of a one-to-one orientation session with the researcher to introduce the training package, followed by a workbook that is completed at home.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
The MemFlex programme draws on cognitive bias modification and memory specificity training techniques (Raes et al., 2009; Dalgleish et al., 2014), and was developed by clinical psychologists. MemFlex is primarily self-guided and aims to reduce autobiographical memory biases associated with depression. The training material is presented over one face-to-face session and eight self-guided sessions. In the initial session, the researcher introduces cued-recall tasks which are used throughout the workbook, and guides the participant in completion of these 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 weekly emails during this period, encouraging them to complete the workbook. They will also receive a phone call from a team member at the beginning of week three to check progress.
memory flexibility training
As in experimental arm description.
(Placebo Comparator)
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. As in the MemFlex condition, the workbook will consist of eight self-guided sessions that the individual will be required to complete over four weeks. The participant will receive weekly emails during this period, encouraging them to complete the workbook. They will also receive a phone call from a team member at the beginning of week three to check progress, and clarify any difficulties with the workbook material. 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 information on psychological theories of the topic, followed by a series of questions about the material to ensure participant engagement. The workbook was developed by clinical psychologists.
psychoeducation
As in experimental arm description.

Primary Outcomes

Measure
Depressive Status
time frame: Three months after completion of the workbook

Secondary Outcomes

Measure
Change in score on the Beck Depression Inventory (Beck, Steer, & Brown, 1996) from baseline
time frame: Three months after completion of the workbook
Change in memory flexibility from baseline, Score on the alternating instructions autobiographical memory task (Dritschel et al., 2013)
time frame: Three months after completion of the workbook

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Currently experiencing Major Depressive Episode, indexed on the Structured Clinical Interview for the DSM-IV (SCID; First et al., 1996). - Score of 13 or above on the Beck Depression Inventory (Beck et al., 1996) Exclusion Criteria: - SCID assessment indicates they are experiencing another mood disorder, psychosis, current alcohol or substance dependence/abuse. - Diagnosed Axis II disorder or brain injury (assessed by participant report)

Additional Information

Official title A Randomized Controlled Trial Comparing Memory Flexibility Training to Psychoeducation in the Treatment of Major Depressive Disorder
Principal investigator Tim Dalgleish, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Medical Research Council Cognition and Brain Sciences Unit.