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Memory Flexibility Training for Depression

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Memory Flexibility Training
Psychoeducation
Sponsored by
Medical Research Council Cognition and Brain Sciences Unit
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Memory Flexibility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • MRC Cognition and Brain Sciences Unit
  • Cambridge and Peterborough NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Memory Flexibility Training

Psychoeducation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Depressive Status
Change in score on the Beck Depression Inventory (Beck, Steer, & Brown, 1996) from baseline
Self report measure of depression symptoms

Secondary Outcome Measures

Depression free days
Number of depression free days from post to follow-up.
Change in memory flexibility from baseline, Score on the alternating instructions autobiographical memory task (Dritschel et al., 2013)
Score on the alternating instructions autobiographical memory task (Dritschel et al., 2013)

Full Information

First Posted
February 9, 2015
Last Updated
September 7, 2017
Sponsor
Medical Research Council Cognition and Brain Sciences Unit
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1. Study Identification

Unique Protocol Identification Number
NCT02371291
Brief Title
Memory Flexibility Training for Depression
Official Title
A Randomized Controlled Trial Comparing Memory Flexibility Training to Psychoeducation in the Treatment of Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical Research Council Cognition and Brain Sciences Unit

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Memory Flexibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memory Flexibility Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Psychoeducation
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Memory Flexibility Training
Intervention Description
As in experimental arm description.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
As in experimental arm description.
Primary Outcome Measure Information:
Title
Depressive Status
Time Frame
Three months after completion of the workbook
Title
Change in score on the Beck Depression Inventory (Beck, Steer, & Brown, 1996) from baseline
Description
Self report measure of depression symptoms
Time Frame
Three months after completion of the workbook
Secondary Outcome Measure Information:
Title
Depression free days
Description
Number of depression free days from post to follow-up.
Time Frame
Three months after completion of the workbook
Title
Change in memory flexibility from baseline, Score on the alternating instructions autobiographical memory task (Dritschel et al., 2013)
Description
Score on the alternating instructions autobiographical memory task (Dritschel et al., 2013)
Time Frame
Three months after completion of the workbook
Other Pre-specified Outcome Measures:
Title
Change in Rumination as measured by Rumination Response Scale
Description
Rumination Response Scale (Treynor, Gonzalez, Nolen-Hoeksema, 2003);
Time Frame
4-6 weeks after beginning the workbook
Title
Change in Cognitive Avoidance, as measured by Cognitive Avoidance Questionnaire
Description
Cognitive Avoidance Questionnaire (Sexton & Dugas, 2008)
Time Frame
4-6 weeks after beginning the workbook
Title
Change in Verbal Fluency as measured by the Verbal Fluency Task
Description
Verbal Fluency Task
Time Frame
4-6 weeks after beginning the workbook
Title
Change in Anxiety symptoms, as measured by the Beck Anxiety Inventory
Description
Beck Anxiety Inventory
Time Frame
4-6 weeks after beginning the workbook
Title
Change in Hopelessness, as measured by Beck Hopelessness Scale
Description
Beck Hopelessness Scale
Time Frame
4-6 weeks after beginning the workbook
Title
Change in Problem solving, as measured by the Means-Ends Problem Solving task
Description
Means-Ends Problem Solving task (Lyubomirsky & Nolen-Hoeksema, 2003)
Time Frame
4-6 weeks after beginning the workbook

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Dalgleish, PhD
Organizational Affiliation
MRC Cognition and Brain Sciences Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
MRC Cognition and Brain Sciences Unit
City
Cambridge
ZIP/Postal Code
CB2 7EF
Country
United Kingdom
Facility Name
Cambridge and Peterborough NHS Foundation Trust
City
Cambridge
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18407245
Citation
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.
Results Reference
background
PubMed Identifier
25052061
Citation
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.
Results Reference
background
Citation
Beck, A., Steer, R., & Brown, G. (1996). Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
30199738
Citation
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.
Results Reference
derived
PubMed Identifier
26531124
Citation
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.
Results Reference
derived

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Memory Flexibility Training for Depression

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