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临床试验/NCT02988518
NCT02988518Unknown不适用

Evaluation of a Cognitive Remediation Program on Patients With Bipolar Disorders, With Memory Complaints

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
41
试验地点
2
主要终点
Evolution of the global functioning between the inclusion and the end of the program

研究概览

简要总结

Bipolar disorder is a major health concern. Intercritical periods are marked with residual symptoms, both thymic and cognitive, which affects quality of life of patients, but also the quality of observance. The implementation of cognitive remediation programs could be interesting. The aim of this study is to evaluate the overall performance on euthymic bipolar patients with memory complaints included in the program named "COGMED", targeting the working memory.

The impact of this program on compliance, quality of life, and memory complaints will be evaluated.

The investigator will measure whether there is a correlation between working memory and overall performances.

Finally, the investigator will try to achieve a profile of bipolar patients in whom the Cogmed program is particularly effective on a plan of overall performance.

详细描述

Patients with bipolar disorder and memory complaints will be recruited.

Two visits :

  1. at baseline (V0) : the investigator evaluate bipolar disorder, treatment, mood, quality of life, global functioning, and memory complaints. Patients also have a neuropsychological assessment. The COGMED program is proposed to patients with memory complaints and explain by the investigator
  2. 4-6 weeks after the end of the program (11-13 weeks after V1) : the same evaluation is realized to compare score before and after the program of cognitive remediation.

Between the two visits the patient will benefit of COGMED program, at home, during 5 weeks.

COGMED is a remediation cognitive program, based on working memory, consisting on daily exercises at home on a computer.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Months 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Evolution of the global functioning between the inclusion and the end of the program

时间窗: At 6 weeks

evaluation of variation of global functioning will be realized by the Functioning Assessment Short Test (FAST) scale after COGMED program

次要结局

  • Observance(At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion))
  • Quality of life(At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion))
  • Correlation between working memory and global functioning(At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion))
  • Memory complaints(At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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