Cognitive Remediation in Schizophrenia

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia; Psychosis
• Intervention / Treatment: Other: Cognitive Remediation Therapy; Other: Placebo comparator

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, 8
    • Recruiting
    • Department of Psychiatry, Trinity Centre for Health Sciences, St James Hospital, James St.
    • Contact: April H Hargreaves, PhD; Phone Number: 35318962624; Email: hargrea@tcd.ie
    • Contact: Rachael Dillon, BSc; Phone Number: 35318962315; Email: radillon@tcd.ie
    • Principal Investigator: Gary J Donohue, DClin Psych PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Cognitive Remediation Therapy; Computerised training undertaken for approximately 30 minutes per day, 5 days per week for 8 weeks; Other Names: CRT
Placebo Comparator: Placebo Comparator; Participants will meet therapist once per week but will not undertake the Computerized Cognitive remediation training.	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).; Other Names: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline neuropsychological performance	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.	Directly following study treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline neuropsychological performance at 3 to 6 months post intervention	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.	3 to 6 months post study treatment period
Changes from baseline in brain activation during working memory testing	Changes from baseline in brain activation during working memory testing will be measured using fMRI	Directly post study treatment period
Change from baseline in grey matter volume	Changes in grey matter volume from baseline will be measured at 3 months post intervention using voxel based morphometry.	Directly following study treatment period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in social and occupational functioning	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)	Directly following study treatment period
Change from baseline in social and occupational functioning 3 to 6 months post intervention	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)	3 to 6 months post study treatment period

Collaborators and Investigators

• Sponsor: University of Dublin, Trinity College
• Collaborators: Health Research Board, Ireland
• Investigators: Principal Investigator: Gary J Donoghoe, DClin Psych PhD, Trinity College Dublin, Ireland

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: July 2, 2013
• First Submitted That Met QC Criteria: July 15, 2013
• First Posted (Estimate): July 19, 2013

Study Record Updates

• Last Update Posted (Estimate): December 5, 2014
• Last Update Submitted That Met QC Criteria: December 4, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Schizophrenia; Psychosis; Cognitive deficits
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: CRT001