Cognitive Remediation Therapy (CRT) in Adolescents With EOS

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Behavioral: Cognitive Remediation Therapy

• Registration Number: NCT01701609
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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.

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 Timeline

• Study Start: 2007-01
• Study First Submitted: 2012-10-03
• Study First Submitted QC: 2012-10-03
• Study First Posted: 2012-10-05
• Primary Completion: 2012-12
• Study Completion: 2013-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Remediation Therapy	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Child and Adolescent Pyshicatry and Psychology; 🇪🇸 Barcelona, Catalunya, Spain