- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02119975
A Working Memory Training to Decrease Rumination in Depressed and Anxious Individuals
April 18, 2014 updated by: Ingmar Franken, Erasmus Medical Center
A Working Memory Training to Decrease Rumination in Depressed and Anxious Individuals: A Double-blind Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
98
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zuid Holland
-
Rotterdam, Zuid Holland, Netherlands, 3000 DR
- Erasmus University Rotterdam
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 67 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Major depression diagnosis
- Anxiety diagnosis
Exclusion Criteria:
- Current psychosis
- Substance abuse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Working memory training
|
|
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Placebo Comparator: Placebo working memory training
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Ruminative Response Scale (RRS) score from pre to post training and after two months (follow up 2)
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)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Beck Depression Inventory Second Edition (BDI-II) score from pre to post training and after two months (follow up 2)
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)
|
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.
|
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)
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)
|
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.
|
Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change in Internal Shift Task (IST) score from pre to post training and to follow up (two months after post)
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)
|
The Internal Shift Task (IST; De Lissnyder et al., 2012) measures the ability to shift attention between items stored in WM.
|
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)
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)
|
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.
|
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)
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)
|
The Reading Span (Daneman & Carpenter, 1980), the third WMC assessment, measures the processing and storage functions of the WM (Shipstead et al., 2012).
|
Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
April 8, 2014
First Submitted That Met QC Criteria
April 18, 2014
First Posted (Estimate)
April 22, 2014
Study Record Updates
Last Update Posted (Estimate)
April 22, 2014
Last Update Submitted That Met QC Criteria
April 18, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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