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Completed

NCT Number: NCT01318850

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Remediation Therapy

Behavioral

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 names: Cognitive training, cognitive enhancement

Psychoeducation

Behavioral

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 names: Coping strategies

Healthy controls

Other

No intervention

Other names: No intervention

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

  2. Social Functioning

    Time frame: Change from baseline in scores of Social Functioning Scale at time 16 weeks

    Score on Social Functioning Scale (SFS)

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Centro de Investigación Biomédica en Red de Salud Mental
  • University of Barcelona

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 21, 2011
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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