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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