Cognitive Remediation in Schizophrenia
4 december 2014 uppdaterad 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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
80
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Dublin, Irland, 8
- Rekrytering
- Department of Psychiatry, Trinity Centre for Health Sciences, St James Hospital, James St.
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Kontakt:
- April H Hargreaves, PhD
- Telefonnummer: 35318962624
- E-post: hargrea@tcd.ie
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Kontakt:
- Rachael Dillon, BSc
- Telefonnummer: 35318962315
- E-post: radillon@tcd.ie
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Huvudutredare:
- Gary J Donohue, DClin Psych PhD
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 60 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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
Andra namn:
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Placebo-jämförare: 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).
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from baseline neuropsychological performance
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from baseline neuropsychological performance at 3 to 6 months post intervention
Tidsram: 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
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Changes in social and occupational functioning
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Gary J Donoghoe, DClin Psych PhD, Trinity College Dublin, Ireland
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2013
Primärt slutförande (Förväntat)
1 juni 2015
Avslutad studie (Förväntat)
1 oktober 2015
Studieregistreringsdatum
Först inskickad
2 juli 2013
Först inskickad som uppfyllde QC-kriterierna
15 juli 2013
Första postat (Uppskatta)
19 juli 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
5 december 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 december 2014
Senast verifierad
1 december 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CRT001
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .