Major Depression Clinical Trial
Official title:
A Working Memory Training to Decrease Rumination in Depressed and Anxious Individuals: A Double-blind Randomized Controlled Trial
NCT number | NCT02119975 |
Other study ID # | 4 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | April 8, 2014 |
Last updated | April 18, 2014 |
Start date | August 2011 |
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.
Status | Completed |
Enrollment | 98 |
Est. completion date | |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 67 Years |
Eligibility |
Inclusion Criteria: - Major depression diagnosis - Anxiety diagnosis Exclusion Criteria: - Current psychosis - Substance abuse |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Erasmus University Rotterdam | Rotterdam | Zuid Holland |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The change in Internal Shift Task (IST) score from pre to post training and to follow up (two months after post) | 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) | No |
Other | The change in Digit Span score from pre to post training and to follow up (two months after post) | 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) | No |
Other | The change in Reading Span partial-credit unit score from pre to post training and to follow up (two months after post) | 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) | No |
Primary | 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) | No |
Secondary | 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. | Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test) | No |
Secondary | 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. | Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test) | No |
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