Clinical Evaluation of Functional Near-infrared Spectroscopy for Anxiety Monitoring and Neurofeedback.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Change in anxiety level as reported in Visual Analog Scale (VAS)
研究概览
简要总结
The objective of this subproject is to validate the efficacy of the fNIRS real-time anxiety monitoring and neurofeedback system. In the first year, the cerebral hemodynamics measured by commercial fNIRS during resting state and cognitive tasks from 60 generalized anxiety disorder (GAD) patients and 30 healthy subjects will be processed and analyzed using AI algorithms. The novel anxiety fNIRS biomarker will be identified and correlated to clinical anxiety scales (such as HARS and STAI). In the second year, the validity and responsiveness of the AI-fNIRS biomarker will be validated. The accuracy of using AI-fNIRS biomarker to predict the diagnosis of GAD (according to DSM-5) and anxiety rating scales will be calculated from 60 GAD patients and 30 healthy subjects. In the third year, a neurofeedback method using AI-fNIRS biomarkers to guide digital cognitive behavior therapy (dCBT) through visual/audio cues will be developed. A pilot study with 12 GAD patients will be performed to test the feasibility of mindfulness training during AI-fNIRS neurofeedback. In the fourth year, a large scale RCT will be performed to validate the therapeutic efficacy of AI-fNIRS neurofeedback dCBT in 40 patients with GAD. The protocol of using real-time AI-fNIRS biomarkers as a neurofeedback to augment mindfulness training will be optimized according to previous year.
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
- Triple (Participant, Care Provider, 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
- 是
入选标准
- •Being diagnosed with generalized anxiety disorder (GAD) by psychiatrists based on DSM-V.
- •Native Chinese speakers.
- •Right-handers.
- •Normal vision without or after correction.
- •Normal hearing and verbal expression.
- •Regular returns of medical or psychological intervention during participation.
排除标准
- •Being diagnosed with other major neurological or mental disorders.
结局指标
主要结局
Change in anxiety level as reported in Visual Analog Scale (VAS)
时间窗: Baseline, 4-week intervention, and 2 months after 4-week intervention.
VAS is a self-report measure. Participants are required to draw a 10 cm line representing their anxiety spectrum, and mark their subjective feelings of anxiety level on it, with the highest on the right end.
Change in physiological anxious symptoms indicated by Heart Rate Variability (HRV)
时间窗: Baseline, 4-week intervention, and 2 months after 4-week intervention.
Measured with NeXus-10MKII (Mind Media, the USA), HRV serves as a physiological index of anxiety. Subjects with anxiety will show lower HRV than healthy individuals.
Change in cerebral hemodynamics from functional near-infrared spectroscopy (fNIRS)
时间窗: Baseline, 4-week intervention, and 2 months after 4-week intervention.
fNIRS is an optical brain monitoring technique. It serves as an ideal tool to record brain activities based on hemodynamics during various cognitive or motor tasks. The regions of interest are bihemispheric prefrontal cortices.
Change in severity of physiological and psychological anxious symptoms as assessed by Hamilton Anxiety Rating Scale (HARS)
时间窗: Baseline, 4-week intervention, and 2 months after 4-week intervention.
Hamilton Anxiety Rating Scale (HARS) is a frequently-used scale in clinical psychiatric fields to assess the severity of anxious symptoms. Conducted by well-trained clinicians, HARS consists of 14 items and can be classified into 2 domains: physiological and psychological anxious symptoms. The minimum and maximum values are 0 and 56 respectively, with higher scores represent worse outcomes.
Change in temporary and long-term anxiety levels as assessed by State-Trait Anxiety Inventory (STAI)
时间窗: Baseline, 4-week intervention, and 2 months after 4-week intervention.
State-Trait Anxiety Inventory (STAI) is a self-report measure of subjective feelings of anxiety. It consists of 2 subscales: state and trait anxiety, with the former characteristic of temporary states of emotion and the latter dealing with the frequency of anxiety and other related emotion in general conditions. The minimum and maximum values of each subscale are 20 and 80 respectively. The higher the score, the higher the level of anxiety.
次要结局
- Change in severity of depressive symptoms as assessed by Hamilton Depression Rating Scale (HAM-D)(Baseline, 4-week intervention, and 2 months after 4-week intervention.)
- Change in performance on emotional dual N-back task(Baseline, 4-week intervention, and 2 months after 4-week intervention.)
- Change in Pittsburgh Sleep Quality Index (PSQI)(Baseline, 4-week intervention, and 2 months after 4-week intervention.)