Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01882452




Registration number
NCT01882452
Ethics application status
Date submitted
18/06/2013
Date registered
20/06/2013
Date last updated
22/03/2018

Titles & IDs
Public title
A Randomised Controlled Clinical Trial of Memory Specificity Training (MEST) for Depression
Scientific title
A Randomised Controlled Clinical Trial of Memory Specificity Training (MEST) for Depression
Secondary ID [1] 0 0
MEST-UK
Universal Trial Number (UTN)
Trial acronym
MEST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 0 0
Depressive Symptoms 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Memory Specificity Training
BEHAVIORAL - Education and Support

Experimental: Memory Specificity Training - Five weekly one-hour sessions of memory specificity training administered in groups of 5-8 participants.

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: 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.

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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in depressive symptoms on the Beck Depression Inventory II (BDI-II)
Timepoint [1] 0 0
Change from baseline to 3 months post-treatment
Secondary outcome [1] 0 0
Change in depressive status according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders - IV (SCID-IV)
Timepoint [1] 0 0
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)
Secondary outcome [2] 0 0
Change from baseline in autobiographical memory specificity on Autobiographical Memory Test (AMT)
Timepoint [2] 0 0
Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Secondary outcome [3] 0 0
Change from baseline in depressive symptoms as measured on the BDI-II
Timepoint [3] 0 0
Change from baseline to post-treatment (approximately 6-weeks)
Secondary outcome [4] 0 0
Depression free days following treatment according to the Longitudinal Follow-up Evaluation on the SCID-IV
Timepoint [4] 0 0
Post-treatment and 3-month and 6-month follow-up

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2016
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Aliza Werner-Seidler - Sydney
Recruitment postcode(s) [1] 0 0
2022 - Sydney

Funding & Sponsors
Primary sponsor type
Government body
Name
Medical Research Council
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
KU Leuven
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tim Dalgleish, PhD
Address 0 0
Medical Research Council
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01882452