- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02119975
A Working Memory Training to Decrease Rumination in Depressed and Anxious Individuals
18. april 2014 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
98
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Zuid Holland
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Rotterdam, Zuid Holland, Nederland, 3000 DR
- Erasmus University Rotterdam
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 67 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Major depression diagnosis
- Anxiety diagnosis
Exclusion Criteria:
- Current psychosis
- Substance abuse
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Arbeidsminnetrening
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Placebo komparator: Placebo working memory training
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
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Studer hoveddatoer
Studiestart
1. august 2011
Primær fullføring (Faktiske)
1. desember 2011
Datoer for studieregistrering
Først innsendt
8. april 2014
Først innsendt som oppfylte QC-kriteriene
18. april 2014
Først lagt ut (Anslag)
22. april 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
22. april 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. april 2014
Sist bekreftet
1. april 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 4
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