- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02119923
Tackling Depression and Anxiety: A Working Memory Intervention
18. april 2014 oppdatert av: Ingmar Franken, Erasmus Medical Center
Effects of Working Memory Training in a Depressed and Anxious Sample
Anxiety and depression are both associated with impairments in executive functions, including working memory (WM) which is needed to maintain and manipulate goal-relevant information.
Due to these WM impairments anxious and depressed individuals have difficulties inhibiting and shifting from irrelevant (negative) information and updating goal relevant information.
This study explored whether training WM decreases these impairments and reduces clinical symptoms and rumination.
Eighty-four individuals diagnosed with major depression and forty-nine individuals with an anxiety diagnosis executed WM or control tasks three times a week, during four weeks.
Before, after training and at a two months follow-up measurement depression and anxiety symptoms, WM capacity and rumination behaviour were assessed.
Training WM did only result in a reduction of anxiety symptoms in the depression group.
These findings are inconsistent with promising results of individual studies showing training WM result in an enlarged WM capacity and a decrease of psychopathological symptoms.
However, our results are in line with recent meta-analyses and reviews which show that WM training do not lead to generalized effects and therefore, doubt the clinical relevance of WM training programs.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
240
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
16 år til 68 år (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Major depression diagnosis
- Anxiety disorder diagnosis
Exclusion Criteria:
- Current psychosis
- Current substance dependency
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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The WM consisted of two tasks; the Number-letter task (Rogers & Monsell, 1995) and an Updating task.
The Number-letter task trains the ability to shift between task relevant stimuli.
Participants need to shift between four categories.
In the Updating task participants receive a set of three words in which they have to compare the two consecutive words on emotional valence (positive or negative) to train their updating skills.
Participants executed the training three times a week during four weeks.
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Placebo komparator: Placebo trening
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Both the WM and the placebo training consisted of two tasks; the Number-letter task (Rogers & Monsell, 1995) and an Updating task.
To prevent training WM the placebo training was a simplified version of the Number-letter task in which shifting was not required.
In the Updating task the placebo group only had to count the number of positive or negative words.
Participants executed the training three times a week during four weeks.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Beck Depression Inventory Second Edition (BDI-II) score change between pre and post training and at follow-up measurement (2 months after post measurement)
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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Depression is measured with the BDI-II
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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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State-Trait Anxiety Inventory (STAI) scores change from pre to post training and to follow up measurement (2 months after post measurement)
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 STAI measures state, trait and total 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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Ruminative Response Scale (RRS) score change between pre and post training and 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 RRS measures rumination
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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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Symmetry Span score change between pre and post training and at follow-up measurement (2 months after post measurement)
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 Symmetry Span measures working memory capacity
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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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Internal shift task score change between pre and post training and at follow-up measurement (2 months after post measurement)
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 measures working memory capacity
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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
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Elke Geraerts, PhD, Erasmus University Rotterdam
- Studieleder: Sabine Wanmaker, MSc, Erasmus University Rotterdam
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2011
Primær fullføring (Faktiske)
1. oktober 2011
Studiet fullført (Faktiske)
1. oktober 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
- 1 (Mobile Health and Wellness Program)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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