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

This study has been completed.
Sponsor:
Collaborators:
University of Barcelona
Centro de Investigación Biomédica en Red de Salud Mental
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01318850
First received: March 18, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Schizophrenia
 Behavioral: Cognitive Remediation Therapy
Behavioral: Psychoeducation
Other: No intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analysis of the Effects of Cognitive Remediation Therapy on Schizophrenia Patients Through fMRI Techniques

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • fMRI patterns of connectivity [ Time Frame: Change from baseline in Fractional Anisotropy an Independent Component Analisys indexes at 16 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from baseline in Positive and Negative Syndrome Scale (PANSS) scores at time 16 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Score on Social Functioning Scale (SFS)


Enrollment: 45
Study Start Date: January 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Remediation Therapy 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 Behavioral: Psychoeducation
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
Healthy Controls Other: No intervention
No intervention
Other Name: No intervention

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01318850

Locations
Spain
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
University of Barcelona
Centro de Investigación Biomédica en Red de Salud Mental
Investigators
Principal Investigator: Rafael Penadés, Ph.D. Hospital Clinic de Barcelona
  More Information

No publications provided

Responsible Party: Rafael Penadés, Hospital Clínic de Barcelona
ClinicalTrials.gov Identifier: NCT01318850     History of Changes
Other Study ID Numbers: PI070258
Study First Received: March 18, 2011
Last Updated: March 18, 2011
Health Authority: Spain: Ministry of Health

Keywords provided by Hospital Clinic of Barcelona:
schizophrenia
cognitive remediation
fMRI

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013