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A Working Memory Training to Decrease Rumination in Depressed and Anxious Individuals

Primary Purpose

Major Depression, Anxiety Disorder

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 Major Depression focused on measuring Rumination, Working memory, Depression, Anxiety, Working memory training, Overgeneral memories

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Major depression diagnosis
  • Anxiety diagnosis

Exclusion Criteria:

  • Current psychosis
  • Substance abuse

Sites / Locations

  • Erasmus University Rotterdam

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo working memory training

Working memory training

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Beck Depression Inventory Second Edition (BDI-II) score from pre to post training and after two months (follow up 2)
The Beck Depression Inventory - II (BDI-II; Beck, Steer, & Brown, 1996; Dutch version: Van der Does, 2002) measures the severity of depression symptoms of the last two weeks.
Change in State-Trait Anxiety Inventory (STAI) score from pre to post training and after two months (follow up 2)
The State-Trait Anxiety Inventory (STAI; Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983, Dutch version; Van der Ploeg, Defares, & Spielberger, 1979) measures self-reported anxiety, divided in state anxiety and trait anxiety.

Full Information

First Posted
April 8, 2014
Last Updated
April 18, 2014
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02119975
Brief Title
A Working Memory Training to Decrease Rumination in Depressed and Anxious Individuals
Official Title
A Working Memory Training to Decrease Rumination in Depressed and Anxious Individuals: A Double-blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2011 (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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Anxiety Disorder
Keywords
Rumination, Working memory, Depression, Anxiety, Working memory training, Overgeneral memories

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Placebo working memory training
Arm Type
Placebo Comparator
Arm Title
Working memory training
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Working memory training
Intervention Type
Behavioral
Intervention Name(s)
Placebo training
Primary Outcome Measure Information:
Title
Change in Ruminative Response Scale (RRS) score from pre to post training and after two months (follow up 2)
Description
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.
Time Frame
Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
Secondary Outcome Measure Information:
Title
Change in Beck Depression Inventory Second Edition (BDI-II) score from pre to post training and after two months (follow up 2)
Description
The Beck Depression Inventory - II (BDI-II; Beck, Steer, & Brown, 1996; Dutch version: Van der Does, 2002) measures the severity of depression symptoms of the last two weeks.
Time Frame
Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
Title
Change in State-Trait Anxiety Inventory (STAI) score from pre to post training and after two months (follow up 2)
Description
The State-Trait Anxiety Inventory (STAI; Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983, Dutch version; Van der Ploeg, Defares, & Spielberger, 1979) measures self-reported anxiety, divided in state anxiety and trait anxiety.
Time Frame
Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
Other Pre-specified Outcome Measures:
Title
The change in Internal Shift Task (IST) score from pre to post training and to follow up (two months after post)
Description
The Internal Shift Task (IST; De Lissnyder et al., 2012) measures the ability to shift attention between items stored in WM.
Time Frame
Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
Title
The change in Digit Span score from pre to post training and to follow up (two months after post)
Description
The Digit Span (Lumley & Calhoun, 1934), which consist of two parts: the forward and backward span, with 14 trials each. The forward Digit Span is a frequently used measure for short term memory, an important subcomponent of the memory system (Shipstead et al., 2012) and the backward version measures WM.
Time Frame
Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
Title
The change in Reading Span partial-credit unit score from pre to post training and to follow up (two months after post)
Description
The Reading Span (Daneman & Carpenter, 1980), the third WMC assessment, measures the processing and storage functions of the WM (Shipstead et al., 2012).
Time Frame
Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Major depression diagnosis Anxiety diagnosis Exclusion Criteria: Current psychosis Substance abuse
Facility Information:
Facility Name
Erasmus University Rotterdam
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3000 DR
Country
Netherlands

12. IPD Sharing Statement

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A Working Memory Training to Decrease Rumination in Depressed and Anxious Individuals

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