Clinical trial NCT01903707: Cognitive Remediation in Schizophrenia
Official title: Cognitive Remediation in Schizophrenia: Effects on Brain Structure, Brain Function and Social Outcome.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Psychosis
Keywords: Schizophrenia
Psychosis
Cognitive deficits
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: Health Research Board, Ireland
First posted: 2013-07-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline neuropsychological performance
timeFrame: Directly following study treatment period
Secondary outcomes:
measure: Change from baseline neuropsychological performance at 3 to 6 months post intervention
timeFrame: 3 to 6 months post study treatment period
measure: Changes from baseline in brain activation during working memory testing
timeFrame: Directly post study treatment period
measure: Change from baseline in grey matter volume
timeFrame: Directly following study treatment period
Other outcomes:
measure: Changes in social and occupational functioning
timeFrame: Directly following study treatment period
measure: Change from baseline in social and occupational functioning 3 to 6 months post intervention
timeFrame: 3 to 6 months post study treatment period
Locations:
city: Dublin
country: Ireland
facility: Department of Psychiatry, Trinity Centre for Health Sciences, St James Hospital, James St.
Study officials:
affiliation: Trinity College Dublin, Ireland
name: Gary J Donoghoe, DClin Psych PhD
role: PRINCIPAL_INVESTIGATOR
References: