Evaluating Cognitive Computer Training as a Tool for Returning Earlier to Work After Depression
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Employment status of the participants at nine months follow-up
研究概览
简要总结
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.
详细描述
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
- 20 Years 至 63 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •neurological disease of the central nervous system
- •alcohol or substance abuse
- •pregnancy
- •receiving disability pension
- •receiving electroconvulsive therapy within the last 6 weeks.
结局指标
主要结局
Employment status of the participants at nine months follow-up
时间窗: When the study is completed, approximately 15 months
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.
次要结局
- The difference in learning from baseline to 3 months follow-up in the intervention group compared to the control group.(approximately nine months)
- The difference in working memory from baseline to 3 months follow-up in the intervention group compared to the control group.(approximately nine months)
- The difference in concentration from baseline to 3 months follow-up in the intervention group compared to the control group.(approximately nine months)
- The difference in attention from baseline to 3 months follow-up in the intervention group compared to the control group(approximately nine months)
- The difference in psychomotor speed from baseline to 3 months follow-up in the intervention group compared to the control group.(approximately nine months)
- The difference in executive function from baseline to 3 months follow-up in the intervention group compared to the control group.(approximately nine months)
研究者
Kjeld Andersen
Professor
University of Southern Denmark