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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02184481
Other study ID # Franken 5
Secondary ID
Status Completed
Phase N/A
First received July 3, 2014
Last updated July 8, 2014
Start date September 2013

Study information

Verified date July 2014
Source Erasmus Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

Depression is 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 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 of depression, anxiety and rumination. Sixty-one students with an elevated score on the BDI-II, representing a dysphoric mood state, executed a working memory training (n = 34) or placebo training (n = 27). Before and after training their depression, anxiety, rumination and working memory were assessed. Furthermore, they executed a working memory task while their pupil dilation was measured to assess their fatigue. Moreover, the investigators compared the dysphoric students with a healthy student population on all measures.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 17 Years and older
Eligibility Inclusion Criteria:

- BDI 10 of higher for dysphoric group

- BDI 5 or lower for healthy control group

Study Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
Working memory training

Placebo training


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 The RRS measures rumination Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) No
Other Spanboard task The Spanboard task measures working memory capacity Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) No
Other N-back task The n-back task was assessed while participants pupil dilation was measured with the eyetracker. The aim of this measurement was to measure fatigue. Pre training (baseline), post training (6 weeks after baseline, training starts 1 day after baseline) No
Primary Beck Depression Inventory Second Edition (BDI-II) score change between pre and post measurement Depression is measured with the BDI-II Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) No
Secondary State-Trait Anxiety Inventory (STAI) scores change from pre to post training measurement The STAI measures state, trait and total anxiety Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) No
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