Effects of Cognitive Remediation Therapy on Schizophrenia Patients Through Functional Magnetic Resonance Imaging
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cognitive Remediation Therapy
Psychoeducation
Healthy controls
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, cognitive remediation, fMRI
Eligibility Criteria
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
Sites / Locations
- Hospital Clinic de Barcelona
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
Cognitive Remediation Therapy
Psychoeducation
Healthy Controls
Arm Description
Cognitive Remediation Therapy -Frontal/Executive Program (Delahunty)- (Wykes and Reeder, 2005)
Symptom Management Module from the University of California. Liberman & Kopelowicz (1995)
Healthy controls
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Symptoms
Scores on Positive and Negative Syndromes Scale (PANSS)
Social Functioning
Score on Social Functioning Scale (SFS)
Full Information
NCT ID
NCT01318850
First Posted
March 18, 2011
Last Updated
February 19, 2016
Sponsor
Hospital Clinic of Barcelona
Collaborators
University of Barcelona, Centro de Investigación Biomédica en Red de Salud Mental
1. Study Identification
Unique Protocol Identification Number
NCT01318850
Brief Title
Effects of Cognitive Remediation Therapy on Schizophrenia Patients Through Functional Magnetic Resonance Imaging
Official Title
Analysis of the Effects of Cognitive Remediation Therapy on Schizophrenia Patients Through fMRI Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
University of Barcelona, Centro de Investigación Biomédica en Red de Salud Mental
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, cognitive remediation, fMRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Remediation Therapy
Arm Type
Experimental
Arm Description
Cognitive Remediation Therapy -Frontal/Executive Program (Delahunty)- (Wykes and Reeder, 2005)
Arm Title
Psychoeducation
Arm Type
Active Comparator
Arm Description
Symptom Management Module from the University of California. Liberman & Kopelowicz (1995)
Arm Title
Healthy Controls
Arm Type
Other
Arm Description
Healthy controls
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation Therapy
Other Intervention Name(s)
Cognitive training, cognitive enhancement
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Other Intervention Name(s)
Coping strategies
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Healthy controls
Other Intervention Name(s)
No intervention
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
fMRI patterns of connectivity
Description
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).
Time Frame
Change from baseline in Fractional Anisotropy an Independent Component Analisys indexes at 16 weeks
Secondary Outcome Measure Information:
Title
Symptoms
Description
Scores on Positive and Negative Syndromes Scale (PANSS)
Time Frame
Change from baseline in Positive and Negative Syndrome Scale (PANSS) scores at time 16 weeks
Title
Social Functioning
Description
Score on Social Functioning Scale (SFS)
Time Frame
Change from baseline in scores of Social Functioning Scale at time 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael Penadés, Ph.D.
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
23452665
Citation
Penades R, Pujol N, Catalan R, Massana G, Rametti G, Garcia-Rizo C, Bargallo N, Gasto C, Bernardo M, Junque C. Brain effects of cognitive remediation therapy in schizophrenia: a structural and functional neuroimaging study. Biol Psychiatry. 2013 May 15;73(10):1015-23. doi: 10.1016/j.biopsych.2013.01.017. Epub 2013 Feb 26. Erratum In: Biol Psychiatry. 2014 Mar 1;75(5):425.
Results Reference
background
PubMed Identifier
26777884
Citation
Penades R, Pujol N, Catalan R, Masana G, Garcia-Rizo C, Bargallo N, Gonzalez-Rodriguez A, Vidal-Pineiro D, Bernardo M, Junque C. Cortical thickness in regions of frontal and temporal lobes is associated with responsiveness to cognitive remediation therapy in schizophrenia. Schizophr Res. 2016 Mar;171(1-3):110-6. doi: 10.1016/j.schres.2016.01.006. Epub 2016 Jan 15.
Results Reference
background
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Effects of Cognitive Remediation Therapy on Schizophrenia Patients Through Functional Magnetic Resonance Imaging
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