fMRI Based Neurofeedback as a Treatment Method for Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at the end of intervention (after 5th session)
研究概览
简要总结
The purpose of the study is to investigate whether neurofeedback delivered via functional magnetic resonance imaging signals can be used to train depressed patients to self-regulate emotion networks and whether this improves clinical symptoms.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •major depressive disorder (MDD) diagnosis
- •stable antidepressant dose medication
排除标准
- •Other physical or psychiatric disorders
- •Current substance abuse
- •Current psychotherapy or other specific intervention
- •Exclusion criteria applicable to MRI
研究组 & 干预措施
Emotion network up-regulation
Participants use fMRI-based neurofeedback to train the upregulation of brain areas that respond to positive affective pictures (as identified during a functional localiser scan).
干预措施: fMRI-based neurofeedback (Other)
Place processing network up-regulation
Participants use fMRI-based neurofeedback to train the upregulation of brain areas that respond to place and house pictures (as identified during a functional localiser scan).
干预措施: fMRI-based neurofeedback (Other)
结局指标
主要结局
Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at the end of intervention (after 5th session)
时间窗: Before start trial (baseline), after intervention (appr. 2 months)
次要结局
- Change from Baseline in Hospital Anxiety and Depression Scale (HADS) anxiety score at the end of intervention (after 5th session)(Baseline, end of intervention (appr. 2 months))
- Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at follow-up(Baseline, 3-month follow-up)
- Change from Baseline in Hospital Anxiety and Depression Scale (HADS) anxiety score at follow-up(Baseline, 3-month follow-up)
- Change from Baseline in Hospital Anxiety and Depression Scale (HADS) depression score at the end of intervention (after 5th session)(Baseline, end of intervention (appr. 2 months))
- Change from Baseline in the Quality of Life Scale (QOLS) at the end of intervention (after 5th session)(Baseline, end of intervention (appr. 2 months))
- Change from Baseline in Hospital Anxiety and Depression Scale (HADS) depression score at follow-up(Baseline, 3-month follow-up)
- Change from Baseline in the Quality of Life Scale (QOLS) at follow-up(Baseline, 3-month follow-up)
- Change from Baseline in the European Quality of Life-5 dimensions scale (EQ-5D) at follow-up(Baseline, 3-month follow-up)
- Change from Baseline in the European Quality of Life-5 dimensions scale (EQ-5D) at the end of intervention (after 5th session)(Baseline, end of intervention (appr. 2 months))
研究者
David Linden
Professor of Translational Neuroscience
Cardiff University