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临床试验/NCT02879604
NCT02879604已完成不适用

Cost-utility Study of a Group of Compensatory Cognitive Remediation in Schizophrenia

University Hospital, Montpellier18 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2018年3月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
218
试验地点
18
主要终点
Cost-utility questionnaire

研究概览

简要总结

Significant cognitive impairment (executive functions, memory, attention) is common in schizophrenia affecting up to 80% of patients. But pharmacological treatments (typical and atypical antipsychotic) do not have impact on cognitive functioning. For over 20 years, alternative non-pharmacological therapeutics have been developed in schizophrenia. These techniques called cognitive remediation specifically target cognitive deficits. The first cognitive remediation available for patients was designed to stimulate new learning, or relearning, of cognitive tasks, and thus to improve certain deficient domains. These procedures were efficient in improving cognition as measured by neurocognitive tests but their impact on functioning and daily life was weak. In a second time, compensatory remediation has been developed. Compensatory approaches seek to make improvements in the patient's functioning by avoiding areas of impairment and recruiting other intact cognitive domains or by creating a supportive external environment. In recent meta-analysis compensatory remediation has larger effect-size than classical cognitive remediation, with an impact on patients psychosocial functioning. Recently, Dr E. Twamley (University of California) developed and tested a group-based, manualized, compensatory cognitive training intervention.

Compensatory cognitive training (CCT) is a low-tech, brief intervention and is easily transposable in community care. Our team translated this method into French. The investigators planned a cost -utility study between CCT and treatment as usual in schizophrenia patients with less than 10 years of evolution.

详细描述

This study will take place over 3 years with a recruitment period of 18 months. After verification of the eligibility criteria and signature of the consent, the patients will be divided into 2 groups by randomization: the intervention group and the control group. The duration of participation of the subjects will be 12 months. Assessments are available in 4 steps (V1 at inclusion, V2 at 3 months, V3 at 6 months and V4 at 12 months). These visits include an assessment of the functioning of patients, symptomatology, quality of life, treatment and care received at all visits, occupational activity and cognitive assessment and social knowledge at V1 and V4.

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
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnostic with schizophrénie
  • Less than 10 years of the evolution of the disease

排除标准

  • History of severe cranial trauma and / or neurological pathology with cognitive impairment
  • Ongoing participation in another study for treatment of negative or cognitive symptoms
  • Ongoing participation in a study on management in psychotherapy for cognitive disorders and negative symptoms

结局指标

主要结局

Cost-utility questionnaire

时间窗: 12 months

Cost difference between the 2 group of patients

次要结局

  • Functioning questionnaire(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (18)

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