- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02119923
Tackling Depression and Anxiety: A Working Memory Intervention
April 18, 2014 updated by: Ingmar Franken, Erasmus Medical Center
Effects of Working Memory Training in a Depressed and Anxious Sample
Anxiety and depression are both associated with impairments in executive functions, including working memory (WM) which is needed to maintain and manipulate goal-relevant information.
Due to these WM impairments anxious and depressed individuals have difficulties inhibiting and shifting from irrelevant (negative) information and updating goal relevant information.
This study explored whether training WM decreases these impairments and reduces clinical symptoms and rumination.
Eighty-four individuals diagnosed with major depression and forty-nine individuals with an anxiety diagnosis executed WM or control tasks three times a week, during four weeks.
Before, after training and at a two months follow-up measurement depression and anxiety symptoms, WM capacity and rumination behaviour were assessed.
Training WM did only result in a reduction of anxiety symptoms in the depression group.
These findings are inconsistent with promising results of individual studies showing training WM result in an enlarged WM capacity and a decrease of psychopathological symptoms.
However, our results are in line with recent meta-analyses and reviews which show that WM training do not lead to generalized effects and therefore, doubt the clinical relevance of WM training programs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
240
Phase
- 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
-
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Zuid Holland
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Rotterdam, Zuid Holland, Netherlands, 3000 DR
- Erasmus University Rotterdam
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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
Ages Eligible for Study
16 years to 68 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Major depression diagnosis
- Anxiety disorder diagnosis
Exclusion Criteria:
- Current psychosis
- Current substance dependency
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Working memory training
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The WM consisted of two tasks; the Number-letter task (Rogers & Monsell, 1995) and an Updating task.
The Number-letter task trains the ability to shift between task relevant stimuli.
Participants need to shift between four categories.
In the Updating task participants receive a set of three words in which they have to compare the two consecutive words on emotional valence (positive or negative) to train their updating skills.
Participants executed the training three times a week during four weeks.
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Placebo Comparator: Placebo training
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Both the WM and the placebo training consisted of two tasks; the Number-letter task (Rogers & Monsell, 1995) and an Updating task.
To prevent training WM the placebo training was a simplified version of the Number-letter task in which shifting was not required.
In the Updating task the placebo group only had to count the number of positive or negative words.
Participants executed the training three times a week during four weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck Depression Inventory Second Edition (BDI-II) score change between pre and post training and at follow-up measurement (2 months after post measurement)
Time Frame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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Depression is measured with the BDI-II
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Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
State-Trait Anxiety Inventory (STAI) scores change from pre to post training and to follow up measurement (2 months after post measurement)
Time Frame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
|
The STAI measures state, trait and total anxiety
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Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ruminative Response Scale (RRS) score change between pre and post training and follow up (two months after post)
Time Frame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
|
The RRS measures rumination
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Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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Symmetry Span score change between pre and post training and at follow-up measurement (2 months after post measurement)
Time Frame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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The Symmetry Span measures working memory capacity
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Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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Internal shift task score change between pre and post training and at follow-up measurement (2 months after post measurement)
Time Frame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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The internal shift task measures working memory capacity
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Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elke Geraerts, PhD, Erasmus University Rotterdam
- Study Director: Sabine Wanmaker, MSc, Erasmus University Rotterdam
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
April 1, 2011
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
April 8, 2014
First Submitted That Met QC Criteria
April 18, 2014
First Posted (Estimate)
April 22, 2014
Study Record Updates
Last Update Posted (Estimate)
April 22, 2014
Last Update Submitted That Met QC Criteria
April 18, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1
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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