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临床试验/NCT03407950
NCT03407950撤回不适用

Cognitive Remediation Program for Hospitalized in the Long Term Patients With Deficit Schizophrenia : Impact on the Capacities of Autonomy

University Hospital, Montpellier1 个研究点 分布在 1 个国家开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Social autonomy

研究概览

简要总结

Schizophrenia is a chronic disease with deficit in social interaction and lost of autonomy in daily life. Negative symptoms as blunted affect, avolition, social deficit and anhedonia and cognition were prognosis and functioning key's factors. Psychotropic medications have shown only poor effect to improve negative symptoms and cognition as attention, memory and cognitive flexibility. So, cognitive remediation programs were developped to focus cognitive disorders. The IPT (Integrated Psychological Treatment) is one of the most complete program with modules on cognitive and social abilities. The aim of this study is to evaluate the efficacy of IPT+ program to improve autonomy capacities of long stay inpatients suffering from schizophrenia 6 at the end of the program With IPT+ this study will improve autonomy capacities for patients suffering from deficit schizophrenia and allowed patients to go out hospital earlier than before.

详细描述

Schizophrenia is a chronic disease with deficit in social interaction and lost of autonomy in daily life. Negative symptoms as blunted affect, avolition, social deficit and anhedonia and cognition were prognosis and functioning key's factors. Psychotropic medications have shown only poor effect to improve negative symptoms and cognition as attention, memory and cognitive flexibility. So, cognitive remediation programs were developped to focus cognitive disorders. The IPT (Integrated Psychological Treatment) is one of the most complete program with modules on cognitive and social abilities. The aim of this study is to evaluate the efficacy of IPT+ program to improve autonomy capacities of long stay inpatients suffering from schizophrenia 6 at the end of the program The secondary objectives are to evaluate autonomy 6 months after the program, to evaluate the efficacy of the program on negative symptoms, quality of life, cognitive functions, social cognition and duration of hospitalisation.

This study propose a randomised controlled study with 2 arms, with blind evaluation to compare the IPT+ versus treatment as usual (TAU). The follow up will be 6 month for the With IPT+ this study will improve autonomy capacities for patients suffering from deficit schizophrenia and allowed patients to go out hospital earlier than before.

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
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •age > 18 and < 60
  • •Diagnosis of schizophrenia on DSM 5
  • •criteria of deficit schizophrenia with the schedule for deficit syndrome
  • •inpatient at inclusion with at least 6 month of hospitalisation during the last 2 years
  • •clinically stable
  • •able to understand, talk and read french
  • •signing consent form

排除标准

  • •change in psychotropic treatment during the last month
  • •psychotherapy in the last 8 months or planned during the study
  • •CDSS score > 9
  • •drug dependency during the last year
  • •unstable somatic disease
  • •somatic disease with impact on cognition

研究组 & 干预措施

Group IPT+

Other

2 sessions of IPT+ by week during 6 months

干预措施: IPT+ (Behavioral)

Control Group

Other

group without specific therapy (Treatment as usual) but same number and duration of each sessions than IPT+

干预措施: Treatment as usual (Behavioral)

结局指标

主要结局

Social autonomy

时间窗: 6 months

Evaluated by Social autonomy Scale (EAS). It's a scale composing by 17 highly-rated items from 0 to 6 (total score varying 0 in 102, a low score indicating a better social autonomy).

次要结局

  • Clinical symptomatology(6 and 12 months)
  • Clinical cognition(6 and 12 months)
  • Clinical functioning(6 and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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