Cognitive Remediation in Schizophrenia

NCT ID: NCT01903707

Last Updated: 2014-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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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

1. Neuropsychological performance
2. Brain Structure using voxel-based morphometry (VBM)
3. Brain function using functional MRI (fMRI)
4. 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.

Conditions

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Schizophrenia Psychosis

Keywords

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Schizophrenia Psychosis Cognitive deficits

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive Remediation Therapy

Intervention Type OTHER

Computerised training undertaken for approximately 30 minutes per day, 5 days per week for 8 weeks

Placebo Comparator

Participants will meet therapist once per week but will not undertake the Computerized Cognitive remediation training.

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type OTHER

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).

Interventions

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Cognitive Remediation Therapy

Computerised training undertaken for approximately 30 minutes per day, 5 days per week for 8 weeks

Intervention Type OTHER

Placebo comparator

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).

Intervention Type OTHER

Other Intervention Names

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CRT No intervention

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Health Research Board, Ireland

OTHER

Sponsor Role collaborator

University of Dublin, Trinity College

OTHER

Sponsor Role lead

Responsible Party

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Gary Donohoe

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gary J Donoghoe, DClin Psych PhD

Role: PRINCIPAL_INVESTIGATOR

Trinity College Dublin, Ireland

Locations

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Department of Psychiatry, Trinity Centre for Health Sciences, St James Hospital, James St.

Dublin, Dublin, Ireland

Site Status RECRUITING

Countries

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Ireland

Central Contacts

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April H Hargreaves, PhD

Role: CONTACT

Phone: 353-1-8962465

Email: [email protected]

Rachael Dillon, Bsc

Role: CONTACT

Phone: 353-1-8962315

Email: [email protected]

Facility Contacts

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April H Hargreaves, PhD

Role: primary

Rachael Dillon, BSc

Role: backup

Other Identifiers

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CRT001

Identifier Type: -

Identifier Source: org_study_id