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Cognitive Remediation Therapy (CRT) in Adolescents With EOS

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01701609
Enrollment
50
Registered
2012-10-05
Start date
2007-01-31
Completion date
2013-07-31
Last updated
2018-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

early-onset schizophrenia, adolescents, cognition, cognitive remediation therapy

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.

Interventions

BEHAVIORALCognitive Remediation Therapy

Sponsors

Instituto de Salud Carlos III
CollaboratorOTHER_GOV
Centro de Investigación Biomédica en Red de Salud Mental
CollaboratorNETWORK
Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cognitive performance20 weeksChange from baseline in neuropsychological test scores of memory, executive functions, working memory and processing speed at post-treatment evaluation

Secondary

MeasureTime frameDescription
Functional outcome20 weeksChange in real-world functioning scales, self-esteem and caregiver burden at post-treatment evaluation
Symptoms20 weeksChange from baseline in measures of clinical symptoms at post-treatment evaluation

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026