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临床试验/NCT01701609
NCT01701609已完成不适用

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

Hospital Clinic of Barcelona2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2007年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Cognitive performance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Cognitive Remediation Therapy

Experimental

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.

干预措施: Cognitive Remediation Therapy (Behavioral)

结局指标

主要结局

Cognitive performance

时间窗: 20 weeks

Change from baseline in neuropsychological test scores of memory, executive functions, working memory and processing speed at post-treatment evaluation

次要结局

  • Functional outcome(20 weeks)
  • Symptoms(20 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Olga Puig

Olga Puig Navarro

Hospital Clinic of Barcelona

研究点 (2)

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