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

NCT01318850 | Completed DMC

• 1 other identifier: PI070258
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

schizophrenia; cognitive remediation; fMRI

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Symptoms

  Change from baseline in Positive and Negative Syndrome Scale (PANSS) scores at time 16 weeks

• Social Functioning

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

Study Arms (3)

Cognitive Remediation Therapy

EXPERIMENTAL

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

Behavioral: Cognitive Remediation Therapy

Psychoeducation

ACTIVE COMPARATOR

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

Behavioral: Psychoeducation

Healthy Controls

OTHER

Healthy controls

Other: Healthy controls

Interventions

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.

Also known as: Cognitive training, cognitive enhancement

Cognitive Remediation Therapy

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.

Also known as: Coping strategies

Psychoeducation

Healthy controls OTHER

No intervention

Also known as: No intervention

Healthy Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Presence of organic-cerebral affectation due to neurological or traumatic conditions
• Abuse of psychotropic substances
• Presence of other psychiatric symptomatology

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• University of Barcelona: collaborator
• Centro de Investigación Biomédica en Red de Salud Mental: collaborator

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Related Publications (2)

• 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.

  PMID: 23452665 BACKGROUND

• 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.

  PMID: 26777884 BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Interventions

Cognitive Training; Coping Skills

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Rafael Penadés, Ph.D.

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: March 18, 2011
• First Posted: March 21, 2011
• Study Start: January 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 22, 2016

Record last verified: 2011-02

Locations

ES (1)