Clinical trial NCT01318850: 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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
cognitive remediation
fMRI
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: University of Barcelona
name: Centro de Investigación Biomédica en Red de Salud Mental
First posted: 2011-03-21
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: fMRI patterns of connectivity
timeFrame: Change from baseline in Fractional Anisotropy an Independent Component Analisys indexes at 16 weeks
Secondary outcomes:
measure: Symptoms
timeFrame: Change from baseline in Positive and Negative Syndrome Scale (PANSS) scores at time 16 weeks
measure: Social Functioning
timeFrame: Change from baseline in scores of Social Functioning Scale at time 16 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Rafael Penadés, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.