The Functional Mechanism of the Neurovascular Coupling: an fMRI-EEG Study in Depressive Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in depression symptoms severity from baseline to mid-treatment
研究概览
简要总结
The aim of the study is to compare the effects of the self-regulation (neurofeedback) of the fMRI signal of the prefrontal cortex in depression to ones of more conventional non-pharmacological treatment, primarily, psychotherapy.
详细描述
The study was devoted to the neural, clinical, and psychological effects of the rt-fMRI neurofeedback for mild/moderate depression. Recruited unmedicated patients suffering from depression were assigned either to the fMRI neurofeedback (8 sessions of the left prefrontal cortex activity regulation) or to the active control group, i.e., a double dosage of cognitive-behavioral treatment or EEG neurofeedback (preliminary aborted). Depression symptoms were measured at baseline, at mid-treatment, and at post-treatment points. Some inventories of depression and related traits were also given. In the rt-fMRI group, self-regulation learning was also estimated by means of the fMRI signal change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of unipolar depressive disorder on ICD-10 (F32, F33, F34.1)
- •Sufficient self-regulation ability (verified with 3 sessions of ALAY EEG neurofeedback)
排除标准
- •Serious somatic, mental, or substance abuse problem other than depression
- •Depression secondary to other mental or somatic conditions
- •Psychotic features in depression or comorbid psychotic disorder
- •Serious suicide risk
- •Seasonal depression
- •Receiving or planning to receive psychotropic medications
- •Receiving cardiovascular medications
- •General MRI exclusions
- •Current pregnancy
- •IQ<70 (established with Raven's progressive matrices)
- •Previous experience with neurofeedback
研究组 & 干预措施
Real-time fMRI neurofeedback (rt-fMRI NFB)
The duration of a session was approximately a half-hour. The course duration was 8 sessions. The preferred frequency was once a week, however, the schedule was flexibly adjusted for patients' convenience.
干预措施: Real-time fMRI neurofeedback (rt-fMRI NFB) (Behavioral)
Сognitive behavioral therapy (CBT)
The duration of a session was approximately an hour/hour and a half. The course duration was 8 individual and 8 group sessions and included home assignments. The preferred frequency was twice a week, however, the schedule was flexibly adjusted for patients' convenience and for improving benefits of the treatment.
干预措施: Сognitive behavioral therapy (CBT) (Behavioral)
EEG neurofeedback (EEG NFB)
The duration of a session was approximately a half-hour. The course duration was 16 sessions. The preferred frequency was twice a week, however, the schedule was flexibly adjusted for patients' convenience.
Group was preliminarily aborted for lack of time and participants in order to assign more patients to the abovementioned arms.
干预措施: EEG neurofeedback (EEG NFB) (Behavioral)
结局指标
主要结局
Change in depression symptoms severity from baseline to mid-treatment
时间窗: 2.5 months on average
Montgomery-Asberg Depression Rating Scale (MADRS), scores ranging 0-54, higher scores indicate more severe depression
Change in depression symptoms severity from baseline to end-treatment
时间窗: 4.5 months on average
Montgomery-Asberg Depression Rating Scale (MADRS), scores ranging 0-54, higher scores indicate more severe depression
次要结局
- Change in subjective depression severity, test 1 from baseline to end-treatment(4.5 months on average)
- Change in subjective depression severity, test 1 from baseline to mid-treatment(2.5 months on average)
- Change in the raw estimate of subjective depression severity from baseline to mid-treatment(2.5 months on average)
- Change in subjective depression severity, test 2 from baseline to end-treatment(4.5 months on average)
- Change in the raw estimate of subjective depression severity from baseline to end-treatment(4.5 months on average)
- Change in subjective depression severity, test 2 from baseline to mid-treatment(2.5 months on average)