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

NCT ID: NCT01318850

Last Updated: 2016-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-12-31

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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive Remediation Therapy

Cognitive Remediation Therapy -Frontal/Executive Program (Delahunty)- (Wykes and Reeder, 2005)

Group Type EXPERIMENTAL

Cognitive Remediation Therapy

Intervention Type 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.

Psychoeducation

Symptom Management Module from the University of California. Liberman \& Kopelowicz (1995)

Group Type ACTIVE_COMPARATOR

Psychoeducation

Intervention Type 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.

Healthy Controls

Healthy controls

Group Type OTHER

Healthy controls

Intervention Type OTHER

No intervention

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Healthy controls

No intervention

Intervention Type OTHER

Other Intervention Names

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Cognitive training, cognitive enhancement Coping strategies No intervention

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Barcelona

OTHER

Sponsor Role collaborator

Centro de Investigación Biomédica en Red de Salud Mental

NETWORK

Sponsor Role collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Rafael Penades

Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rafael Penadés, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

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Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 23452665 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26777884 (View on PubMed)

Other Identifiers

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PI070258

Identifier Type: -

Identifier Source: org_study_id

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