NCT02184481

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
Last Updated

July 9, 2014

Status Verified

July 1, 2014

Enrollment Period

9 months

First QC Date

July 3, 2014

Last Update Submit

July 8, 2014

Conditions

Depression

Keywords

DepressionAnxietyWorking memoryRuminationCognitive trainingExecutive functioning

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • State-Trait Anxiety Inventory (STAI) scores change from pre to post training measurement

    Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)

Other Outcomes (3)

  • Ruminative Response Scale (RRS) score change between pre and post training

    Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)

  • Spanboard task

    Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline)

  • N-back task

    Pre training (baseline), post training (6 weeks after baseline, training starts 1 day after baseline)

Study Arms (2)

Working memory training

EXPERIMENTAL

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.

Behavioral: Working memory training

Placebo training

PLACEBO COMPARATOR

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.

Behavioral: Placebo training

Interventions

Working memory trainingBEHAVIORAL
Working memory training
Placebo trainingBEHAVIORAL
Placebo training

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus University Rotterdam

Rotterdam, South Holland, 3000 DR, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 26075389DERIVED

MeSH Terms

Conditions

DepressionAnxiety DisordersRumination Syndrome

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersGastrointestinal DiseasesDigestive System DiseasesFeeding and Eating Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 3, 2014

First Posted

July 9, 2014

Study Start

September 1, 2013

Primary Completion

June 1, 2014

Last Updated

July 9, 2014

Record last verified: 2014-07

Locations

NL(1)