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临床试验/NCT02038465
NCT02038465Unknown不适用

REMEDIATION COGNITIVE DE LA MÉMOIRE AUTOBIOGRAPHIQUE DANS LA SCHIZOPHRENIE AU MOYEN DE SENSECAM

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
Specificity of memories recovered by using the SenseCam camera during the trial

研究概览

简要总结

The aim of the study is to assess the efficiency of SenseCam® in patients with schizophrenia by comparing two cognitive remediation methods of autobiographical memory.Patients and control participants will be invited to carry SenseCam® during 7 hours per day minimum and for 4 successive days. Each ending day when carry SenseCam®, they will be asked to go to the laboratory where 4 types of interventions will be successively done according to the randomization: 1) a simple visual retrospective procedure (SVR), 2) a visual retrospective procedure coupled with a specific cueing intervention (VR-SC), 3) a verbal retrospective (VbR) and 4) no intervention (control condition).The testing phase will take place 14 days after the last day of data collection and will consist in a cued recall task and a recognition task using the pictures obtained by the SenseCam® of the participants.According to our hypotheses, the vividness of memories will be higher in events subjected to the VR-SC procedure than in events subjected to the SVR and VbR procedures. This effect is expected for both patients with schizophrenia and controls participants. Since strategies to enrich memory details will be explicitly given to the patients when using the VR-SC procedure, we assume that patients will be able to normalize their scores.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • for both patients and controls
  • male or female willing to participate and who have signed up the legal document
  • under the protection of health insurancefor patients only
  • schizophrenia or schizo-affective disorder according to the DSM-IV
  • TR criteria
  • clinically stable for at least 2 monthsfor controls only
  • no psychiatric history

排除标准

  • for both patients and controls
  • current severe or unstable somatic illness
  • neurological history (epilepsia, brain injury, brain surgery…)
  • current substance use disorder (DSM-IV-TR)
  • current major depressive disorder (DSM-IV-TR)
  • mental retardation (IQ < 70)
  • pregnancy, breast feeding
  • current legal controlfor patients only
  • treatment comprising benzodiazepines
  • benzodiazepines intake during the last 3 weeksfor controls only
  • psychotropic intake during the last 3 weeks

结局指标

主要结局

Specificity of memories recovered by using the SenseCam camera during the trial

时间窗: 1 month

Test the effectiveness of two techniques of cognitive remediation of autobiographical memory using an innovative tool called SenseCam.This specificity will be evaluated by the experimenter by scoring wealth in detail memories reported during the cued recall task

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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