Effects of Cognitive Remediation Therapy on Schizophrenia Patients Through Functional Magnetic Resonance Imaging
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|ClinicalTrials.gov Identifier: NCT01318850|
Recruitment Status : Completed
First Posted : March 21, 2011
Last Update Posted : February 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Behavioral: Cognitive Remediation Therapy Behavioral: Psychoeducation Other: Healthy controls||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Analysis of the Effects of Cognitive Remediation Therapy on Schizophrenia Patients Through fMRI Techniques|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Experimental: Cognitive Remediation Therapy
Cognitive Remediation Therapy -Frontal/Executive Program (Delahunty)- (Wykes and Reeder, 2005)
Behavioral: Cognitive Remediation Therapy
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.
Other Name: Cognitive training, cognitive enhancement
Active Comparator: Psychoeducation
Symptom Management Module from the University of California. Liberman & Kopelowicz (1995)
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.
Other Name: Coping strategies
Other: Healthy controls
Other Name: No intervention
- fMRI patterns of connectivity [ Time Frame: Change from baseline in Fractional Anisotropy an Independent Component Analisys indexes at 16 weeks ]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).
- Symptoms [ Time Frame: Change from baseline in Positive and Negative Syndrome Scale (PANSS) scores at time 16 weeks ]Scores on Positive and Negative Syndromes Scale (PANSS)
- Social Functioning [ Time Frame: Change from baseline in scores of Social Functioning Scale at time 16 weeks ]Score on Social Functioning Scale (SFS)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318850
|Hospital Clinic de Barcelona|
|Barcelona, Spain, 08036|
|Principal Investigator:||Rafael Penadés, Ph.D.||Hospital Clinic of Barcelona|