Efficacy of a Neurofeedback Treatment in Adults With ADHD: a Triple-blind Randomized Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Changes in ADHD symptomatology
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ADHD diagnosis
- •sufficient knowledge of the German language
排除标准
- •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
研究组 & 干预措施
Neurofeedback active
Active neurofeedback training, theta/beta-protocol
干预措施: Neurofeedback active (Behavioral)
Neurofeedback sham
Neurofeedback training is simulated to subjects in this condition
干预措施: Neurofeedback active (Behavioral)
Neurofeedback sham
Neurofeedback training is simulated to subjects in this condition
干预措施: Neurofeedback sham (Behavioral)
Metacognitive Training
Metacognitive training, cognitive behavioral therapy
干预措施: Metacognitive Training (Behavioral)
结局指标
主要结局
Changes in ADHD symptomatology
时间窗: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
Conners' Adult ADHD Rating Scale (CAARS) Scores
次要结局
- Changes in neuropsychological variables: Interference(pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up))
- Changes in event-related potentials 1(pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up))
- Changes in event-related potentials 2(pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up))
- Changes in neuropsychological variables: Attention(pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up))
- Changes in co-morbid depression scores(pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up))
- Changes in co-morbid anxiety scores(pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up))
- Changes in neuropsychological variables: Cognitive Flexibility 1(pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up))
- Changes in electrophysiological markers(pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up))
- Changes in neuropsychological variables: Cognitive Flexibility 2(pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up))
研究者
Dr. Michael Schoenenberg
Efficacy of a Neurofeedback Treatment in Adults With ADHD: a Triple-blind Randomized Placebo-controlled Study
University Hospital Tuebingen