Cognitive Remediation Therapy (CRT) in Adolescents With EOS

Efficacy of a Cognitive Remediation Treatment in Adolescents With Schizophrenia Spectrum Disorders

Cognitive Remediation Therapy (CRT) can enhance cognitive performance in schizophrenia improving functional outcome. But most of the studies have involved participants who are in average in their mid 30s, and little is known about the efficacy of CRT in adolescents with early-onset schizophrenia (EOS). The aim of this study is to investigate efficacy of CRT in improving cognitive performance and functional outcome in adolescents with EOS. We expect to find that CRT improves cognitive and functional outcomes in adolescents with schizophrenia.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: Cognitive Remediation Therapy

Detailed Description

Early-onset schizophrenia (EOS) is associated with worse course and poor outcome than adulthood schizophrenia. Cognitive deficits are known to be a core feature in EOS, with large deficits on almost all cognitive domains. Importantly, cognitive deficits are known to be strong predictors of psychosocial and functional outcomes in schizophrenia and also in the early-onset form of the illness. Cognitive Remediation Therapy (CRT) is a behavioral training based intervention that aims to improve cognitive processes (attention, memory, executive function, social cognition or metacognition) with the goal of durability and generalization. It has been demonstrated that CRT improve cognitive deficits and functional outcome in adult patients but there are very few studies with adolescent samples.

A controlled randomized study will be carry out with two groups: patients receiving treatment as usual plus CRT, and patients receiving treatment as usual (TAU). The independent variable is the cognitive remediation treatment. The CRT will be applied according to the manual of Wykes and Reeder (2005). The program has a duration of 40 sessions, with two session for week. It is carried out individually and utilizes paper and pencil tasks. The main technique utilized is the scaffolding in a context of learning without errors.

The main dependent variable is the cognitive performance measured through neuropsychological tests. Other secondary dependent variables are functional outcome and clinical symptoms obtained from the psychometric evaluation.

All participants will be evaluated before and after the experimental intervention in several neurocognitive domains, clinical symptoms and functional outcome. The evaluations will be carried out by expert evaluators. Intention-to-treat analysis will be carry out using the statistical package SPSS v 18.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Catalunya
    • Barcelona, Catalunya, Spain, 08036
      • Department of Child and Adolescent Pyshicatry and Psychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age between 12 and 18 years
• a DSM-IV-TR schizophrenia-type disorder (schizophrenia or schizoaffective disorder), with onset before the age of 17
• being clinically and pharmacologically stabilized during the last 6 weeks before the baseline assessment
• the estimation of not modifying pharmacological antipsychotic treatment
• presence of cognitive deficit confirmed by the neuropsychological battery

Exclusion Criteria:

• IQ below 70
• presence of an active misuse disorder
• presence of organic brain syndromes or neurological disorders
• having received electroconvulsive therapy in the previous 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Remediation Therapy; CRT: Frontal/Executive Program. The program has a duration of 40 sessions, with two session for week. Is is carried out individually and utilizes paper and pencil tasks. The main technique utilized is the scaffolding in a context of learning without errors.	Behavioral: Cognitive Remediation Therapy; Other Names: Cognitive training; Cognitive enhancement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive performance	Change from baseline in neuropsychological test scores of memory, executive functions, working memory and processing speed at post-treatment evaluation	20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome	Change in real-world functioning scales, self-esteem and caregiver burden at post-treatment evaluation	20 weeks
Symptoms	Change from baseline in measures of clinical symptoms at post-treatment evaluation	20 weeks

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Instituto de Salud Carlos III; Centro de Investigación Biomédica en Red de Salud Mental
• Investigators: Principal Investigator: Olga Puig, PhD, Hospital Clinic of Barcelona; Study Director: Rafael Penadés, PhD, Hospital Clinic of Barcelona; Study Director: Josefina Castro-Fornieles, MD, Hospital Clinic of Barcelona

Publications and helpful links

General Publications

• Puig O, Penades R, Baeza I, De la Serna E, Sanchez-Gistau V, Bernardo M, Castro-Fornieles J. Cognitive remediation therapy in adolescents with early-onset schizophrenia: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2014 Aug;53(8):859-68. doi: 10.1016/j.jaac.2014.05.012. Epub 2014 Jun 21.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2007
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: October 3, 2012
• First Submitted That Met QC Criteria: October 3, 2012
• First Posted (Estimate): October 5, 2012

Study Record Updates

• Last Update Posted (Actual): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: cognition; adolescents; early-onset schizophrenia; cognitive remediation therapy
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: PI07/90054; ETES07/90054 (Other Grant/Funding Number: ISCIII)