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A Randomised Controlled Clinical Trial of Memory Specificity Training (MEST) for Depression (MEST)

Primary Purpose

Major Depressive Disorder, Depressive Symptoms

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Memory Specificity Training
Education and Support
Sponsored by
Medical Research Council
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Memory specificity training, Autobiographical memory, Major depressive disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Principal diagnosis of Major Depressive Disorder
  • History of more than one previous depressive episode
  • Current diagnosis of a Major Depressive Episode
  • Depressive symptoms rated in the mild-severe range (> 13 on the BDI-II)
  • Memory specificity < .70 (as assessed on the AMT)

Exclusion Criteria:

  • Head trauma
  • Organic brain damage
  • Secondary diagnosis of another affective disorder
  • Psychosis
  • Current drug or alcohol abuse or dependence
  • A diagnosed Axis II disorder

Sites / Locations

  • Aliza Werner-Seidler

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Memory Specificity Training

Education and Support

Arm Description

Five weekly one-hour sessions of memory specificity training administered in groups of 5-8 participants.

Five weekly one-hour sessions of an education-and-discussion supportive intervention, administered in groups of 5-8 participants.

Outcomes

Primary Outcome Measures

Change from baseline in depressive symptoms on the Beck Depression Inventory II (BDI-II)
Symptom severity score

Secondary Outcome Measures

Change in depressive status according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders - IV (SCID-IV)
Presence of a current Major Depressive Episode (MDE)
Change from baseline in autobiographical memory specificity on Autobiographical Memory Test (AMT)
Memory specificity level
Change from baseline in depressive symptoms as measured on the BDI-II
Symptom severity score
Depression free days following treatment according to the Longitudinal Follow-up Evaluation on the SCID-IV
Number of depression-free days

Full Information

First Posted
June 18, 2013
Last Updated
March 21, 2018
Sponsor
Medical Research Council
Collaborators
KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01882452
Brief Title
A Randomised Controlled Clinical Trial of Memory Specificity Training (MEST) for Depression
Acronym
MEST
Official Title
A Randomised Controlled Clinical Trial of Memory Specificity Training (MEST) for Depression
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Research Council
Collaborators
KU Leuven

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Depression involves the tendency to recall overgeneral personal memories, a phenomenon which has been linked to numerous adverse psychological outcomes. The purpose of this study is to investigate whether a group-based Memory Specificity Training (MEST) programme improves outcomes in depression, and how this compares to an education and support control group. The primary aim is to examine whether MEST, which involves repeated practice retrieving specific autobiographical memories reduces depressive symptoms immediately post-treatment, and whether this is maintained 3 months after treatment. The secondary objective of this trial is to examine the role of hypothesised cognitive processes (ie., rumination, executive control, cognitive avoidance) which may underlie improvements in depression and memory.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Depressive Symptoms
Keywords
Memory specificity training, Autobiographical memory, Major depressive disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memory Specificity Training
Arm Type
Experimental
Arm Description
Five weekly one-hour sessions of memory specificity training administered in groups of 5-8 participants.
Arm Title
Education and Support
Arm Type
Active Comparator
Arm Description
Five weekly one-hour sessions of an education-and-discussion supportive intervention, administered in groups of 5-8 participants.
Intervention Type
Behavioral
Intervention Name(s)
Memory Specificity Training
Intervention Description
This intervention is a manualised, structured treatment delivered over 5 x 60 minute sessions to groups of 5-8 individuals. This treatment involves repeated practice of retrieving specific autobiographical memories in response to positive, negative and neutral cue words. There is a single psychoeducation component in the first session about memory difficulties common in depression which provides the rationale for this treatment. The training is supplemented by weekly homework practice.
Intervention Type
Behavioral
Intervention Name(s)
Education and Support
Intervention Description
The education-and-support comparison condition is matched with the experimental arm for length and format (ie., 5 x 60 minute weekly sessions in groups of 5-8 individuals). Groups receive a single psychoeducation component where information about depression is provided. This is followed by non-directive support where participants are encouraged to raise different kinds of events that occur each week for discussion in the group. The sessions are supplemented by a homework diary where participants will be invited to note down an event that occurs each day, which may be positive, negative, or benign and non-emotional in nature. This material will provide the basis for discussion in the weekly group meetings.
Primary Outcome Measure Information:
Title
Change from baseline in depressive symptoms on the Beck Depression Inventory II (BDI-II)
Description
Symptom severity score
Time Frame
Change from baseline to 3 months post-treatment
Secondary Outcome Measure Information:
Title
Change in depressive status according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders - IV (SCID-IV)
Description
Presence of a current Major Depressive Episode (MDE)
Time Frame
Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment, and 6-months post-treatment (6-month follow-up for MEST group only)
Title
Change from baseline in autobiographical memory specificity on Autobiographical Memory Test (AMT)
Description
Memory specificity level
Time Frame
Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Title
Change from baseline in depressive symptoms as measured on the BDI-II
Description
Symptom severity score
Time Frame
Change from baseline to post-treatment (approximately 6-weeks)
Title
Depression free days following treatment according to the Longitudinal Follow-up Evaluation on the SCID-IV
Description
Number of depression-free days
Time Frame
Post-treatment and 3-month and 6-month follow-up
Other Pre-specified Outcome Measures:
Title
Change from baseline on the Beck Anxiety Inventory (BAI)
Description
Symptom severity score
Time Frame
Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Title
Change from baseline on the Beck Hopelessness Scale (BHS)
Description
Hopelessness score
Time Frame
Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Title
Change from baseline on the Cognitive Avoidance Questionnaire (CAQ)
Description
Tendency for avoidance score
Time Frame
Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Title
Change in baseline on Rumination Response Scale (RRS)
Description
Tendency to ruminate score
Time Frame
Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Title
Change from baseline in performance on Means-Ends Problem Solving Task (MEPS)
Description
Problem solving effectiveness score
Time Frame
Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Title
Change from baseline in performance on Verbal Fluency Task
Description
Index of executive control
Time Frame
Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Title
Change in baseline on performance on Digit Span Task
Description
Working memory index
Time Frame
Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Principal diagnosis of Major Depressive Disorder History of more than one previous depressive episode Current diagnosis of a Major Depressive Episode Depressive symptoms rated in the mild-severe range (> 13 on the BDI-II) Memory specificity < .70 (as assessed on the AMT) Exclusion Criteria: Head trauma Organic brain damage Secondary diagnosis of another affective disorder Psychosis Current drug or alcohol abuse or dependence A diagnosed Axis II disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Dalgleish, PhD
Organizational Affiliation
Medical Research Council
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aliza Werner-Seidler
City
Sydney
ZIP/Postal Code
2022
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
29587159
Citation
Werner-Seidler A, Hitchcock C, Bevan A, McKinnon A, Gillard J, Dahm T, Chadwick I, Panesar I, Breakwell L, Mueller V, Rodrigues E, Rees C, Gormley S, Schweizer S, Watson P, Raes F, Jobson L, Dalgleish T. A cluster randomized controlled platform trial comparing group MEmory specificity training (MEST) to group psychoeducation and supportive counselling (PSC) in the treatment of recurrent depression. Behav Res Ther. 2018 Jun;105:1-9. doi: 10.1016/j.brat.2018.03.004. Epub 2018 Mar 15.
Results Reference
derived
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
derived

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A Randomised Controlled Clinical Trial of Memory Specificity Training (MEST) for Depression

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