Efficacy of Neurofeedback Training in Adults With ADHD
2017年3月8日 更新者：Dr. Michael Schoenenberg、University Hospital Tuebingen
Efficacy of a Neurofeedback Treatment in Adults With ADHD: a Triple-blind Randomized Placebo-controlled Study
Neurofeedback training (NFT) has been frequently investigated as an alternative treatment for ADHD mainly in children and adolescents. However, randomized double-blind trials that include a sham-neurofeedback control group are lacking, as well as studies examining the efficacy of NFT in adult ADHD populations. The inclusion of a sham-neurofeedback group is crucial to monitor and exclude unspecific effects.
This study aims to investigate the efficacy of NFT as compared to a sham-feedback condition and a cognitive behavioral treatment in adults with persistent ADHD.
Efficacy is assessed on several outcome parameters, such as symptom severity, neuropsychological variables (e.g., attention, memory), and EEG parameters.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
118
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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Baden-Württemberg
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Tuebingen、Baden-Württemberg、德国、72076
- Universitat Tubingen
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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
18年 至 60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:
- ADHD diagnosis
- sufficient knowledge of the German language
Exclusion criteria:
- psychiatric disorder(s) lifetime (bipolar disorder, schizophrenia, schizoaffective disorder, borderline personality disorder)
- neurological disorder (e.g., epilepsy)
- current substance abuse disorder
- receives psychotherapy (e.g., CBT) or medication
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：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Neurofeedback active
Active neurofeedback training, theta/beta-protocol
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假比较器：Neurofeedback sham
Neurofeedback training is simulated to subjects in this condition
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其他名称：
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有源比较器：Metacognitive Training
Metacognitive training, cognitive behavioral therapy
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其他名称：
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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 |
|---|---|---|
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Changes in ADHD symptomatology
大体时间：pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
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Conners' Adult ADHD Rating Scale (CAARS) Scores
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pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in co-morbid depression scores
大体时间：pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
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Beck Depression Inventory (BDI) Scores
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pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
|
Changes in co-morbid anxiety scores
大体时间：pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
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State Trait Anxiety Inventory (STAI) Scores
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pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
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Changes in neuropsychological variables: Attention
大体时间：pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
Continuous Performance Test (CPT), Errors in Omission and Errors in Commission
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pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
|
Changes in neuropsychological variables: Interference
大体时间：pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
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Stroop Color-Word Test, Interference scores
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pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
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Changes in neuropsychological variables: Cognitive Flexibility 1
大体时间：pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
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Test for Attentional Performance (TAP) - Flexibility, RT in ms and Errors
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pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
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Changes in neuropsychological variables: Cognitive Flexibility 2
大体时间：pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
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Inventory for Complex Attention (INKA), Items correctly performed
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pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
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Changes in electrophysiological markers
大体时间：pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
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Ln-transformed theta/beta ratio
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pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
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Changes in event-related potentials 1
大体时间：pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
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Contingent Negative Variation Amplitudes
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pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
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Changes in event-related potentials 2
大体时间：pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
Emitted P 300 Amplitudes
|
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
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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：Michael Schönenberg, Dr、University Hospital Tuebingen
- 学习椅：Martin Hautzinger, Prof. Dr.、University Hospital Tuebingen
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2013年2月1日
初级完成 (实际的)
2015年12月1日
研究完成 (实际的)
2016年11月1日
研究注册日期
首次提交
2013年2月21日
首先提交符合 QC 标准的
2013年6月18日
首次发布 (估计)
2013年6月21日
研究记录更新
最后更新发布 (实际的)
2017年3月13日
上次提交的符合 QC 标准的更新
2017年3月8日
最后验证
2017年3月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
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.
Neurofeedback active的临床试验
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Sophiahemmet UniversityKarolinska Institutet; Linnaeus University; The Swedish School of Sport and Health Sciences; Stockholm... 和其他合作者尚未招聘