Cognitive Computer Training in Patients With Depression
2016年6月29日 更新者：Kjeld Andersen、University of Southern Denmark
Evaluating Cognitive Computer Training as a Tool for Returning Earlier to Work After Depression
Cognitive impairment plays an important role in functional recovery and leads to long-term sickness absence.
Therefore there is a need of a treatment specifically improving cognitive functions.
In this pilot study the investigators aim to evaluate the feasibility of using cognitive computer training in patients with unipolar depression to enhance cognitive performance.
Further the investigators investigate whether this intervention shortens sick leave.
研究概览
详细说明
This study will evaluate cognitive computer training on patients in remission from depression by measuring the compliance and effect, investigating whether patients returned earlier to work and examine patients' physical and psychological health. This is done by comparing an intervention group and a control group.
Outpatients from psychiatric department Odense in Denmark will be recruited from December 2015 to July 2017.
At enrolment the participants wil be randomized 1:1 to either the intervention group or the control group. After the participants will complete a clinical interview and answer the The Short Form (36) Health Survey (SF-36) questionnaire. The participants' cognitive function and depression severity will be measured at baseline and three months follow-up. At nine months follow-up the participants will receive an email with the SF-36 questionnaire and questions about their education and work status, which they were required to answer.
The intervention is a cognitive computer program, consisting of different computer games. The intervention will start at enrolment and finish at the three months follow-up. The participants in the intervention group will do trainings session lasting 10-20 minutes three times a week. Each participant ends up with a total of 36 training sessions.
研究类型
介入性
注册 (预期的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Region of southern Denmark
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Odense C、Region of southern Denmark、丹麦、5000
- 招聘中
- Research Unit of Psychiatry, Psychiatric Unit Odense - University function
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接触：
- Anja F Elliott, BACH.MED.
- 电话号码：+4560795724
- 邮箱：anjaelliott@hotmail.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 63年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- a diagnosis of a moderate to severe unipolar depression according to the International Classification of Diseases -10 criteria
- receiving antidepressant medicine
- completed their treatment for depression
- not be in any risk of suicide
- study or work on reduced hours, be unemployed or on long-term sickness leave at enrolment.
Exclusion Criteria:
- neurological disease of the central nervous system
- alcohol or substance abuse
- pregnancy
- receiving disability pension
- receiving electroconvulsive therapy within the last 6 weeks.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Cognitive computer training
This is the intervention group receiving cognitive computer training three times a week for three months.
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COGNIFIT is cognitive computer training.
Its purpose is to improve cognitive function and is designed to accommodate each individual's cognitive strengths and weaknesses.
The cognitive computer training last three months and must be done three times a week, in session lasting 10-20 minutes.
其他名称：
|
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无干预：cogntrol group
The control group do not receive cognitive computer training for three months
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Employment status of the participants at nine months follow-up
大体时间：When the study is completed, approximately 15 months
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Questionnaire about employment status and will be send to the participants via email at nine months follow-up.
The questionnaire include questions according to: current working situation; why they are not working; when they started working; do they work at the same workplace; do they have the same work assignments as before they got ill; do whey work the same number of hour as before the got ill.
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When the study is completed, approximately 15 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The difference in concentration from baseline to 3 months follow-up in the intervention group compared to the control group.
大体时间：approximately nine months
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Concentration is measured by The Digit Span Test
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approximately nine months
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The difference in attention from baseline to 3 months follow-up in the intervention group compared to the control group
大体时间：approximately nine months
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Attention is measured by The Letter Cancellation Test
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approximately nine months
|
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The difference in working memory from baseline to 3 months follow-up in the intervention group compared to the control group.
大体时间：approximately nine months
|
Working memory is measured by The Letter Number Sequencing
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approximately nine months
|
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The difference in learning from baseline to 3 months follow-up in the intervention group compared to the control group.
大体时间：approximately nine months
|
Learning is measured by the Rey Auditory Verbal Learning Test.
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approximately nine months
|
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The difference in executive function from baseline to 3 months follow-up in the intervention group compared to the control group.
大体时间：approximately nine months
|
Executive function is measured by The Verbal Fluency
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approximately nine months
|
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The difference in psychomotor speed from baseline to 3 months follow-up in the intervention group compared to the control group.
大体时间：approximately nine months
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Psychomotor speed is measured by The Trial Making Test (TMT).
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approximately nine months
|
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The difference in executive function from baseline to 3 months follow-up in the intervention group compared to the control group.
大体时间：approximately nine months
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Executive function is measured by The Tower of London
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approximately nine months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Compliance of cognitive computer training
大体时间：approximately nine months
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The participants were supposed to do 36 sessions of cognitive computer training during three months.
The actual completed trainings sessions are available on the website of the cognitive computer training, called COGNIFIT.
The compliance is defined as the percentage of actual completed training sessions of the 36 sessions of training.
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approximately nine months
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The difference in health status from baseline to 9 months follow-up in the intervention group compared to the control group.
大体时间：approximately 15 months
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The health status is measured by a patient-reported survey called the The Short Form (36) Health Survey (SF-36) questionnaire
|
approximately 15 months
|
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The difference in depression severity from baseline to 3 months follow-up in the intervention group compared to the control group.
大体时间：approximately nine months
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The depression severity is measured by Hamilton Rating Scale for Depression (17-items)
|
approximately nine months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Bent Nielsen, Prof.MD、University of Southern Denmark
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年12月1日
初级完成 (预期的)
2017年10月1日
研究完成 (预期的)
2017年10月1日
研究注册日期
首次提交
2016年6月6日
首先提交符合 QC 标准的
2016年6月29日
首次发布 (估计)
2016年7月4日
研究记录更新
最后更新发布 (估计)
2016年7月4日
上次提交的符合 QC 标准的更新
2016年6月29日
最后验证
2016年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.