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Working Memory Training for Dysphoric Students

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Working memory training
Placebo training
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Anxiety, Working memory, Rumination, Cognitive training, Executive functioning

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BDI 10 of higher for dysphoric group
  • BDI 5 or lower for healthy control group

Sites / Locations

  • Erasmus University Rotterdam

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Working memory training

Placebo training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Beck Depression Inventory Second Edition (BDI-II) score change between pre and post measurement
Depression is measured with the BDI-II

Secondary Outcome Measures

State-Trait Anxiety Inventory (STAI) scores change from pre to post training measurement
The STAI measures state, trait and total anxiety

Full Information

First Posted
July 3, 2014
Last Updated
July 8, 2014
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02184481
Brief Title
Working Memory Training for Dysphoric Students
Official Title
Working Memory Training to Decrease Depression, Anxiety and Rumination in Dysphoric Students
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Anxiety, Working memory, Rumination, Cognitive training, Executive functioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Working memory training
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo training
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Working memory training
Intervention Type
Behavioral
Intervention Name(s)
Placebo training
Primary Outcome Measure Information:
Title
Beck Depression Inventory Second Edition (BDI-II) score change between pre and post measurement
Description
Depression is measured with the BDI-II
Time Frame
Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
Secondary Outcome Measure Information:
Title
State-Trait Anxiety Inventory (STAI) scores change from pre to post training measurement
Description
The STAI measures state, trait and total anxiety
Time Frame
Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
Other Pre-specified Outcome Measures:
Title
Ruminative Response Scale (RRS) score change between pre and post training
Description
The RRS measures rumination
Time Frame
Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
Title
Spanboard task
Description
The Spanboard task measures working memory capacity
Time Frame
Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)
Title
N-back task
Description
The n-back task was assessed while participants pupil dilation was measured with the eyetracker. The aim of this measurement was to measure fatigue.
Time Frame
Pre training (baseline), post training (6 weeks after baseline, training starts 1 day after baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BDI 10 of higher for dysphoric group BDI 5 or lower for healthy control group
Facility Information:
Facility Name
Erasmus University Rotterdam
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3000 DR
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
26075389
Citation
Hopstaken JF, Wanmaker S, van der Linden D, Bakker AB. Does Dysphoria Lead to Divergent Mental Fatigue Effects on a Cognitive Task? PLoS One. 2015 Jun 15;10(6):e0130304. doi: 10.1371/journal.pone.0130304. eCollection 2015.
Results Reference
derived

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Working Memory Training for Dysphoric Students

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