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

March 21, 2018 updated by: Professor Tim Dalgleish, Medical Research Council
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Sydney, Australia, 2022
        • Aliza Werner-Seidler

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Memory Specificity Training
Five weekly one-hour sessions of memory specificity training administered in groups of 5-8 participants.
Behavioral: Memory Specificity Training
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.
Active Comparator: Education and Support
Five weekly one-hour sessions of an education-and-discussion supportive intervention, administered in groups of 5-8 participants.
Behavioral: Education and Support
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in depressive symptoms on the Beck Depression Inventory II (BDI-II)
Time Frame: Change from baseline to 3 months post-treatment
Symptom severity score
Change from baseline to 3 months post-treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in depressive status according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders - IV (SCID-IV)
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)
Presence of a current Major Depressive Episode (MDE)
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)
Change from baseline in autobiographical memory specificity on Autobiographical Memory Test (AMT)
Time Frame: Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Memory specificity level
Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Change from baseline in depressive symptoms as measured on the BDI-II
Time Frame: Change from baseline to post-treatment (approximately 6-weeks)
Symptom severity score
Change from baseline to post-treatment (approximately 6-weeks)
Depression free days following treatment according to the Longitudinal Follow-up Evaluation on the SCID-IV
Time Frame: Post-treatment and 3-month and 6-month follow-up
Number of depression-free days
Post-treatment and 3-month and 6-month follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline on the Beck Anxiety Inventory (BAI)
Time Frame: Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Symptom severity score
Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Change from baseline on the Beck Hopelessness Scale (BHS)
Time Frame: Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Hopelessness score
Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Change from baseline on the Cognitive Avoidance Questionnaire (CAQ)
Time Frame: Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Tendency for avoidance score
Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Change in baseline on Rumination Response Scale (RRS)
Time Frame: Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Tendency to ruminate score
Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Change from baseline in performance on Means-Ends Problem Solving Task (MEPS)
Time Frame: Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Problem solving effectiveness score
Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Change from baseline in performance on Verbal Fluency Task
Time Frame: Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Index of executive control
Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Change in baseline on performance on Digit Span Task
Time Frame: Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Working memory index
Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical Research Council

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
KU Leuven

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tim Dalgleish, PhD, Medical Research Council

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MEST-UK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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