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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02119923
Other study ID # 1
Secondary ID
Status Completed
Phase N/A
First received April 8, 2014
Last updated April 18, 2014
Start date April 2011
Est. completion date October 2011

Study information

Verified date April 2014
Source Erasmus Medical Center
Contact n/a
Is FDA regulated No
Health authority The Netherlands: Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 68 Years
Eligibility Inclusion Criteria:

- Major depression diagnosis

- Anxiety disorder diagnosis

Exclusion Criteria:

- Current psychosis

- Current substance dependency

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Behavioral:
Working memory training
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.
Placebo training
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.

Locations

Country Name City State
Netherlands Erasmus University Rotterdam Rotterdam Zuid Holland

Sponsors (1)

Lead Sponsor Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other Ruminative Response Scale (RRS) score change between pre and post training and follow up (two months after post) The RRS measures rumination Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test) No
Other Symmetry Span score change between pre and post training and at follow-up measurement (2 months after post measurement) The Symmetry Span measures working memory capacity Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test) No
Other Internal shift task score change between pre and post training and at follow-up measurement (2 months after post measurement) The internal shift task measures working memory capacity Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test) No
Primary Beck Depression Inventory Second Edition (BDI-II) score change between pre and post training and at follow-up measurement (2 months after post measurement) Depression is measured with the BDI-II Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test) No
Secondary State-Trait Anxiety Inventory (STAI) scores change from pre to post training and to follow up measurement (2 months after post measurement) The STAI measures state, trait and total anxiety Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test) No
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