NCT02119975

Brief Summary

Dysfunctioning executive functioning, including working memory (WM), is related to rumination. Findings show that working memory capacity (WMC) can be increased by training. The current study explored by means of a double-blind randomized controlled trial whether an adaptive WM training could reduce rumination, anxiety and depression in a sample of 98 depressed and anxious individuals.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 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

August 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2.4 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

4 months

First QC Date

April 8, 2014

Last Update Submit

April 18, 2014

Conditions

Major DepressionAnxiety Disorder

Keywords

RuminationWorking memoryDepressionAnxietyWorking memory trainingOvergeneral memories

Outcome Measures

Primary Outcomes (1)

  • Change in Ruminative Response Scale (RRS) score from pre to post training and after two months (follow up 2)

    Dutch version; Raes, Hermans, \& Eelen, 2003) measures the frequency of self-reported rumination behavior, with answer options ranging from 1 (never) to 4 (always). The total score of the 22 items was used in the analyses.

    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 (2)

  • Change in Beck Depression Inventory Second Edition (BDI-II) score from pre to post training and after two months (follow up 2)

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

  • Change in State-Trait Anxiety Inventory (STAI) score from pre to post training and after two months (follow up 2)

    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)

  • The change in Internal Shift Task (IST) score from pre to post training and to 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)

  • The change in Digit Span score from pre to post training and to 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)

  • The change in Reading Span partial-credit unit score from pre to post training and to 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)

Study Arms (2)

Placebo working memory training

PLACEBO COMPARATOR
Behavioral: Placebo training

Working memory training

EXPERIMENTAL
Behavioral: Working memory training

Interventions

Working memory trainingBEHAVIORAL
Working memory training
Placebo trainingBEHAVIORAL
Placebo working memory training

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major depression diagnosis
  • Anxiety diagnosis

You may not qualify if:

  • Current psychosis
  • Substance abuse

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 DisordersRumination SyndromeDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersGastrointestinal DiseasesDigestive System DiseasesFeeding and Eating DisordersBehavioral SymptomsBehavior

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

August 1, 2011

Primary Completion

December 1, 2011

Last Updated

April 22, 2014

Record last verified: 2014-04

Locations

NL(1)