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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01882452
Other study ID # MEST-UK
Secondary ID
Status Completed
Phase N/A
First received June 18, 2013
Last updated March 21, 2018
Start date July 2013
Est. completion date October 2016

Study information

Verified date March 2018
Source Medical Research Council
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
Australia Aliza Werner-Seidler Sydney

Sponsors (2)

Lead Sponsor Collaborator
Medical Research Council Katholieke Universiteit Leuven

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Other Change from baseline on the Beck Anxiety Inventory (BAI) Symptom severity score Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Other Change from baseline on the Beck Hopelessness Scale (BHS) Hopelessness score Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Other Change from baseline on the Cognitive Avoidance Questionnaire (CAQ) Tendency for avoidance score Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Other Change in baseline on Rumination Response Scale (RRS) Tendency to ruminate score Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Other Change from baseline in performance on Means-Ends Problem Solving Task (MEPS) Problem solving effectiveness score Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Other Change from baseline in performance on Verbal Fluency Task Index of executive control Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Other Change in baseline on performance on Digit Span Task Working memory index Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Primary Change from baseline in depressive symptoms on the Beck Depression Inventory II (BDI-II) Symptom severity score Change from baseline to 3 months post-treatment
Secondary 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 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 Change from baseline in autobiographical memory specificity on Autobiographical Memory Test (AMT) Memory specificity level Change from baseline at end of treatment (approximately 6 weeks) and 3 months post-treatment
Secondary Change from baseline in depressive symptoms as measured on the BDI-II Symptom severity score Change from baseline to post-treatment (approximately 6-weeks)
Secondary Depression free days following treatment according to the Longitudinal Follow-up Evaluation on the SCID-IV Number of depression-free days Post-treatment and 3-month and 6-month follow-up
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