- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02184481
Working Memory Training for Dysphoric Students
July 8, 2014 updated by: Ingmar Franken, Erasmus Medical Center
Working Memory Training to Decrease Depression, Anxiety and Rumination in Dysphoric Students
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
94
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
17 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BDI 10 of higher for dysphoric group
- BDI 5 or lower for healthy control group
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
Participants executed the training for three weeks, three times a week, half an hour per session.
The training was a game in which the participant was a person who had to become strong to fight with a fantasy figure.
The person could become stronger when giving the right answers in eight different working memory tasks.
The level adapted to the working memory capacity of the participant.
|
|
|
Placebo Comparator: Placebo training
Participants executed the training for three weeks, three times a week, half an hour per session.
The training was a game in which the participant was a person who had to become strong to fight with a fantasy figure.
The person could become stronger when giving the right answers in eight different working memory tasks.
The level in the placebo condition was easy and did not adapt to the working memory capacity of the participant.
|
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 measurement
Time Frame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
|
Depression is measured with the BDI-II
|
Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State-Trait Anxiety Inventory (STAI) scores change from pre to post training measurement
Time Frame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
|
The STAI measures state, trait and total anxiety
|
Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ruminative Response Scale (RRS) score change between pre and post training
Time Frame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
|
The RRS measures rumination
|
Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
|
|
Spanboard task
Time Frame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
|
The Spanboard task measures working memory capacity
|
Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
|
|
N-back task
Time Frame: Pre training (baseline), post training (6 weeks after baseline, training starts 1 day after baseline)
|
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)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
September 1, 2013
Primary Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
July 3, 2014
First Submitted That Met QC Criteria
July 8, 2014
First Posted (Estimate)
July 9, 2014
Study Record Updates
Last Update Posted (Estimate)
July 9, 2014
Last Update Submitted That Met QC Criteria
July 8, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Franken 5
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