Cognitive Remediation in Schizophrenia
4. desember 2014 oppdatert av: Gary Donohoe, University of Dublin, Trinity College
Cognitive Remediation in Schizophrenia: Effects on Brain Structure, Brain Function and Social Outcome.
The aim of this project is to undertake a randomized placebo controlled trial of cognitive remediation therapy (CRT) that focuses on working memory training in a sample of community based patients with chronic schizophrenia or other psychoses.
Cognitive deficits are a problem for many people with schizophrenia. This study will use computerized cognitive remediation training (which the participant can carry out at home) over a period of a few months.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The aim of this project is to undertake a randomized placebo controlled trial of cognitive remediation therapy (CRT) that focuses on working memory training in a sample of community based patients with schizophrenia. Pre and Post neuropsychological assessment and Magnetic Resonance Imagery (MRI) will be used to determine the effects of CR training on
- Neuropsychological performance
- Brain Structure using voxel-based morphometry (VBM)
- Brain function using functional MRI (fMRI)
- Social and occupational functioning
The cognitive remediation intervention is a computerised programme whose training level is dynamically varied to suit participants individual ability level. Motivation to learn and generalization to real world function are a particular focus of the intervention and are supported with ongoing therapist interaction in addition to personal training.
Studietype
Intervensjonell
Registrering (Forventet)
80
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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Dublin, Irland, 8
- Rekruttering
- Department of Psychiatry, Trinity Centre for Health Sciences, St James Hospital, James St.
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Ta kontakt med:
- April H Hargreaves, PhD
- Telefonnummer: 35318962624
- E-post: hargrea@tcd.ie
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Ta kontakt med:
- Rachael Dillon, BSc
- Telefonnummer: 35318962315
- E-post: radillon@tcd.ie
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Hovedetterforsker:
- Gary J Donohue, DClin Psych PhD
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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 60 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Schizophrenia
- History of Psychosis
- Subjective difficulties with memory or concentration
- Aged 18-60 Years
Exclusion Criteria:
- History of head injury resulting in loss of consciousness
- Substance misuse in the last 3 months
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: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Cognitive Remediation Therapy
Participants will undertake approximately 30 minutes of computerized CRT training for 8 weeks, 5 days per week.
They will meet a therapist once per week to discuss any difficulties, help motivation.
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Computerised training undertaken for approximately 30 minutes per day, 5 days per week for 8 weeks
Andre navn:
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Placebo komparator: Placebo Comparator
Participants will meet therapist once per week but will not undertake the Computerized Cognitive remediation training.
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Participant meets the therapist once per week but does not carry out the CRT intervention.
(Participants are subsequently offered the chance to carry out the CRT intervention post study if they so wish).
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline neuropsychological performance
Tidsramme: Directly following study treatment period
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A battery of neuropsychological tests will be used at baseline and the same tests used directly after the intervention to measure changes in attention and memory.
Tests include Wechsler Adult intelligence scale-III, Wechsler Memory Scale-III, Stroop test, Wisconsin card sorting task and measures of spatial working memory.
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Directly following study treatment period
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline neuropsychological performance at 3 to 6 months post intervention
Tidsramme: 3 to 6 months post study treatment period
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A battery of neuropsychological tests will be used at baseline and the same tests used at 3 months post intervention to measure changes in attention and memory.
Tests include Wechsler Adult intelligence scale-III, Wechsler Memory Scale-III, Stroop test, Wisconsin card sorting task and measures of spatial working memory.
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3 to 6 months post study treatment period
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Changes from baseline in brain activation during working memory testing
Tidsramme: Directly post study treatment period
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Changes from baseline in brain activation during working memory testing will be measured using fMRI
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Directly post study treatment period
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Change from baseline in grey matter volume
Tidsramme: Directly following study treatment period
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Changes in grey matter volume from baseline will be measured at 3 months post intervention using voxel based morphometry.
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Directly following study treatment period
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in social and occupational functioning
Tidsramme: Directly following study treatment period
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Social and occupational function will be measured at baseline and the same tests used directly following intervention.
Standardised measures will be used including ILS (Independent Living Scales) and the UCSD performance skills assessment brief version(UPSA-B)
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Directly following study treatment period
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Change from baseline in social and occupational functioning 3 to 6 months post intervention
Tidsramme: 3 to 6 months post study treatment period
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Social and occupational function will be measured at baseline and the same tests used directly following intervention.
Standardised measures will be used including ILS (Independent Living Scales) and the UCSD performance skills assessment brief version(UPSA-B)
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3 to 6 months post study treatment period
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Gary J Donoghoe, DClin Psych PhD, Trinity College Dublin, Ireland
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. mai 2013
Primær fullføring (Forventet)
1. juni 2015
Studiet fullført (Forventet)
1. oktober 2015
Datoer for studieregistrering
Først innsendt
2. juli 2013
Først innsendt som oppfylte QC-kriteriene
15. juli 2013
Først lagt ut (Anslag)
19. juli 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
5. desember 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. desember 2014
Sist bekreftet
1. desember 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CRT001
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. .