- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02371291
Memory Flexibility Training for Depression
A Randomized Controlled Trial Comparing Memory Flexibility Training to Psychoeducation in the Treatment of Major Depressive Disorder
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Cambridge, United Kingdom, CB2 7EF
- MRC Cognition and Brain Sciences Unit
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Cambridge, United Kingdom
- Cambridge and Peterborough NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Memory Flexibility Training
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.
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As in experimental arm description.
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Placebo Comparator: Psychoeducation
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.
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As in experimental arm description.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depressive Status
Time Frame: Three months after completion of the workbook
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Three months after completion of the workbook
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Change in score on the Beck Depression Inventory (Beck, Steer, & Brown, 1996) from baseline
Time Frame: Three months after completion of the workbook
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Self report measure of depression symptoms
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Three months after completion of the workbook
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression free days
Time Frame: Three months after completion of the workbook
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Number of depression free days from post to follow-up.
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Three months after completion of the workbook
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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
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Score on the alternating instructions autobiographical memory task (Dritschel et al., 2013)
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Three months after completion of the workbook
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Rumination as measured by Rumination Response Scale
Time Frame: 4-6 weeks after beginning the workbook
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Rumination Response Scale (Treynor, Gonzalez, Nolen-Hoeksema, 2003);
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4-6 weeks after beginning the workbook
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Change in Cognitive Avoidance, as measured by Cognitive Avoidance Questionnaire
Time Frame: 4-6 weeks after beginning the workbook
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Cognitive Avoidance Questionnaire (Sexton & Dugas, 2008)
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4-6 weeks after beginning the workbook
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Change in Verbal Fluency as measured by the Verbal Fluency Task
Time Frame: 4-6 weeks after beginning the workbook
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Verbal Fluency Task
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4-6 weeks after beginning the workbook
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Change in Anxiety symptoms, as measured by the Beck Anxiety Inventory
Time Frame: 4-6 weeks after beginning the workbook
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Beck Anxiety Inventory
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4-6 weeks after beginning the workbook
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Change in Hopelessness, as measured by Beck Hopelessness Scale
Time Frame: 4-6 weeks after beginning the workbook
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Beck Hopelessness Scale
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4-6 weeks after beginning the workbook
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Change in Problem solving, as measured by the Means-Ends Problem Solving task
Time Frame: 4-6 weeks after beginning the workbook
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Means-Ends Problem Solving task (Lyubomirsky & Nolen-Hoeksema, 2003)
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4-6 weeks after beginning the workbook
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Collaborators and Investigators
Investigators
- Principal Investigator: Tim Dalgleish, PhD, MRC Cognition and Brain Sciences Unit
Publications and helpful links
General Publications
- Raes F, Williams JM, Hermans D. Reducing cognitive vulnerability to depression: a preliminary investigation of MEmory Specificity Training (MEST) in inpatients with depressive symptomatology. J Behav Ther Exp Psychiatry. 2009 Mar;40(1):24-38. doi: 10.1016/j.jbtep.2008.03.001. Epub 2008 Mar 12.
- Dalgleish T, Bevan A, McKinnon A, Breakwell L, Mueller V, Chadwick I, Schweizer S, Hitchcock C, Watson P, Raes F, Jobson L, Werner-Seidler A. A comparison of MEmory Specificity Training (MEST) to education and support (ES) in the treatment of recurrent depression: study protocol for a cluster randomised controlled trial. Trials. 2014 Jul 22;15:293. doi: 10.1186/1745-6215-15-293.
- Beck, A., Steer, R., & Brown, G. (1996). Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation.
- First, M., Spitzer, R., Gibbons, M., & Williams, J. (1996). Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-IV). Washington, DC: American Psychiatric Press.
- Hitchcock C, Gormley S, Rees C, Rodrigues E, Gillard J, Panesar I, Wright IM, Hammond E, Watson P, Werner-Seidler A, Dalgleish T. A randomised controlled trial of memory flexibility training (MemFlex) to enhance memory flexibility and reduce depressive symptomatology in individuals with major depressive disorder. Behav Res Ther. 2018 Nov;110:22-30. doi: 10.1016/j.brat.2018.08.008. Epub 2018 Aug 29.
- Hitchcock C, Hammond E, Rees C, Panesar I, Watson P, Werner-Seidler A, Dalgleish T. Memory Flexibility training (MemFlex) to reduce depressive symptomatology in individuals with major depressive disorder: study protocol for a randomised controlled trial. Trials. 2015 Nov 3;16:494. doi: 10.1186/s13063-015-1029-y.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mrccbu
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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