Effects of Cognitive Remediation Therapy on Schizophrenia Patients Through Functional Magnetic Resonance Imaging

Study Overview
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Brief Summary
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Cognitive Remediation Therapy (CRT) can enhance cognitive performance in patients with schizophrenia improving clinical outcome. However, the neurobiological mechanism underlying cognitive improvement is not well understood. The aim of this study is to investigate functional connectivity patterns before and after the neurocognitive rehabilitation therapy, especially in fronto-temporal circuitry.

Detailed Description
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A controlled randomized study will be carry out with three different groups: patients receiving cognitive rehabilitation treatment (CRT), patients receiving another psychological intervention of control and a healthy control group. A descriptive study of cases will be also carried out. The functional MRI (fRMI) techniques as well as voxel-based morphometry allow individual analysis of cases. The independent variable is the cognitive rehabilitation treatment. The CRT will be applied according to the manual of Wykes & Reeder (2005) Cognitive Remediation Therapy: Theory and Practice, Ed: Routledge. The program has a duration of 40 sessions (one hour of duration), with two sessions for week during four months. It is carried out individually and utilizes paper and pencil tasks. The main technique utilized is the scaffolding (to provide strategies when the patient cannot carry out the task and to withdraw him when he is yet able of doing it alone) in a context of learning without errors. The main dependent variable is the functional connectivity cerebral pattern obtained by means of functional magnetic resonance. Other secondary dependent variables are neurocognitive functioning, the symptomatic pattern and the psychosocial functioning obtained from the psychometric evaluation. All the participants will be evaluated before and after the experimental intervention in neurocognitive areas (Battery will be composed by WAIS-III, RAVLT, Trail Making Test, STROOP color word, WCST, FAS-COWAT), symptomatic area (PANSS) and in social functioning (Social Functioning Scale SFS; Birchwood et al. 1990). The evaluations will be carried out by expert evaluators that will be blind to the experimental distribution. The statistics results analysis will be carry out by means of the statistical package SPSS 15.

Official Title
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Analysis of the Effects of Cognitive Remediation Therapy on Schizophrenia Patients Through fMRI Techniques

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: Cognitive Remediation Therapy
* Behavioral: Psychoeducation
* Other: Healthy controls


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of schizophrenia according to DSM-IV-TR and confirmed by the semi-structured interview (SCID) for the axis 1. Presence of cognitive deficit confirmed by the neuropsychological battery. Stable symptomatology at least during the last six months and the estimation of not modifying pharmacological antipsychotic treatment. Exclusion Criteria: Presence of organic-cerebral affectation due to neurological or traumatic conditions Abuse of psychotropic substances Presence of other psychiatric symptomatology

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Remediation Therapy<br>Cognitive Remediation Therapy -Frontal/Executive Program (Delahunty)- (Wykes and Reeder, 2005) | Behavioral: Cognitive Remediation Therapy<br>* The program has a duration of 40 sessions (one hour of duration), with two sessions for week during four months. It is carried out individually and utilizes paper and pencil tasks. The main technique utilized is the scaffolding (to provide strategies when the patient cannot carry out the task and to withdraw him when he is yet able of doing it alone) in a context of learning without errors.<br>* Other names: Cognitive training, cognitive enhancement;|
| Active Comparator: Psychoeducation<br>Symptom Management Module from the University of California. Liberman & Kopelowicz (1995) | Behavioral: Psychoeducation<br>* The program has a duration of 40 sessions (one hour of duration), with two sessions for week during four months. It is carried out individually and utilizes teaching information and coping skills and neuropsychological issues are not addressed.<br>* Other names: Coping strategies;|
| Other: Healthy Controls<br>Healthy controls | Other: Healthy controls<br>* No intervention<br>* Other names: No intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fMRI patterns of connectivity | Scores on Fractional Anisotropy (FA) index from the Diffusor Technique Images (DTI) and Tract Based Spatial Statistics (TBSS) analyses. Also, scores in the Independent Component Analysis (ICA). | Change from baseline in Fractional Anisotropy an Independent Component Analisys indexes at 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms | Scores on Positive and Negative Syndromes Scale (PANSS) | Change from baseline in Positive and Negative Syndrome Scale (PANSS) scores at time 16 weeks | 
| Social Functioning | Score on Social Functioning Scale (SFS) | Change from baseline in scores of Social Functioning Scale at time 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, cognitive remediation, fMRI