NCT02119923

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 22, 2014

Completed
Last Updated

April 22, 2014

Status Verified

April 1, 2014

Enrollment Period

6 months

First QC Date

April 8, 2014

Last Update Submit

April 18, 2014

Conditions

Keywords

DepressionAnxietyWorking memoryRuminationCognitive trainingExecutive functioning

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • State-Trait Anxiety Inventory (STAI) scores change from pre to post training and to follow up measurement (2 months after post measurement)

    Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)

Other Outcomes (3)

  • Ruminative Response Scale (RRS) score change between pre and post training and follow up (two months after post)

    Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)

  • Symmetry Span score change between pre and post training and at follow-up measurement (2 months after post measurement)

    Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)

  • Internal shift task score change between pre and post training and at follow-up measurement (2 months after post measurement)

    Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)

Study Arms (2)

Working memory training

EXPERIMENTAL
Behavioral: Working memory training

Placebo training

PLACEBO COMPARATOR
Behavioral: Placebo training

Interventions

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.

Working memory 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.

Placebo training

Eligibility Criteria

Age16 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Major depression diagnosis
  • Anxiety disorder diagnosis

You may not qualify if:

  • Current psychosis
  • Current substance dependency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus University Rotterdam

Rotterdam, South Holland, 3000 DR, Netherlands

Location

MeSH Terms

Conditions

Depressive Disorder, MajorAnxiety DisordersDepressionRumination Syndrome

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehaviorGastrointestinal DiseasesDigestive System DiseasesFeeding and Eating Disorders

Study Officials

  • Elke Geraerts, PhD

    Erasmus University Rotterdam

    PRINCIPAL INVESTIGATOR
  • Sabine Wanmaker, MSc

    Erasmus University Rotterdam

    STUDY DIRECTOR

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

April 8, 2014

First Posted

April 22, 2014

Study Start

April 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

April 22, 2014

Record last verified: 2014-04

Locations