Cognitive Remediation in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Cognitive Remediation in Schizophrenia: Effects on Brain Structure, Brain Function and Social Outcome.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01903707
• Other study ID #: CRT001
• Status: Recruiting
• Phase: N/A
• First received: July 2, 2013
• Last updated: December 4, 2014
• Start date: May 2013
• Est. completion date: October 2015

Study information

• Verified date: December 2014
• Source: University of Dublin, Trinity College
• Contact: April H Hargreaves, PhD
• Phone: 353-1-8962465
• Email: hargrea[@]tcd.ie
• Is FDA regulated: No
• Health authority: Faculty Research Ethics Committee, TCD, Dublin, Ireland:
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychosis
• Schizophrenia

Intervention

Other:
• Cognitive Remediation Therapy
Computerised training undertaken for approximately 30 minutes per day, 5 days per week for 8 weeks
• 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).

Locations

Country	Name	City	State
Ireland	Department of Psychiatry, Trinity Centre for Health Sciences, St James Hospital, James St.	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
University of Dublin, Trinity College	Health Research Board, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Website of the neuropsychiatric genetics group at Trinity College Dublin, Ireland