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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01318850
• Other study ID #: PI070258
• Status: Completed
• Phase: N/A
• First received: March 18, 2011
• Last updated: February 19, 2016
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: February 2011
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.
• 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:
• Healthy controls
No intervention

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Centro de Investigación Biomédica en Red de Salud Mental, University of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Penadés R, Pujol N, Catalán R, Masana G, García-Rizo C, Bargalló N, González-Rodríguez A, Vidal-Piñeiro D, Bernardo M, Junqué 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. — View Citation

Penadés R, Pujol N, Catalán R, Massana G, Rametti G, García-Rizo C, Bargalló N, Gastó C, Bernardo M, Junqué 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change from baseline in Fractional Anisotropy an Independent Component Analisys indexes at 16 weeks	No
Secondary	Symptoms	Scores on Positive and Negative Syndromes Scale (PANSS)	Change from baseline in Positive and Negative Syndrome Scale (PANSS) scores at time 16 weeks	No
Secondary	Social Functioning	Score on Social Functioning Scale (SFS)	Change from baseline in scores of Social Functioning Scale at time 16 weeks	No