- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02119975
A Working Memory Training to Decrease Rumination in Depressed and Anxious Individuals
18. april 2014 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
98
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Zuid Holland
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Rotterdam, Zuid Holland, Holland, 3000 DR
- Erasmus University Rotterdam
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 67 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Major depression diagnosis
- Anxiety diagnosis
Exclusion Criteria:
- Current psychosis
- Substance abuse
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Træning af arbejdshukommelse
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Placebo komparator: Placebo working memory training
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Ruminative Response Scale (RRS) score from pre to post training and after two months (follow up 2)
Tidsramme: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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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.
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Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Beck Depression Inventory Second Edition (BDI-II) score from pre to post training and after two months (follow up 2)
Tidsramme: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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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.
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Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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Change in State-Trait Anxiety Inventory (STAI) score from pre to post training and after two months (follow up 2)
Tidsramme: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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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.
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Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The change in Internal Shift Task (IST) score from pre to post training and to follow up (two months after post)
Tidsramme: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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The Internal Shift Task (IST; De Lissnyder et al., 2012) measures the ability to shift attention between items stored in WM.
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Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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The change in Digit Span score from pre to post training and to follow up (two months after post)
Tidsramme: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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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.
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Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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The change in Reading Span partial-credit unit score from pre to post training and to follow up (two months after post)
Tidsramme: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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The Reading Span (Daneman & Carpenter, 1980), the third WMC assessment, measures the processing and storage functions of the WM (Shipstead et al., 2012).
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Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2011
Primær færdiggørelse (Faktiske)
1. december 2011
Datoer for studieregistrering
Først indsendt
8. april 2014
Først indsendt, der opfyldte QC-kriterier
18. april 2014
Først opslået (Skøn)
22. april 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
22. april 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. april 2014
Sidst verificeret
1. april 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 4
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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