Neurofeedback Training to Improve Prefrontal Functioning in Older Adults With Subclinical Depression and Anxiety: a Randomised Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Mood symptoms (post)
研究概览
简要总结
Symptoms of depression and anxiety are common in older adults and are associated with poor outcomes and the risk of dementia. The prefrontal cortex (PFC) is crucial for emotion regulation. Poor PFC function may underlie subclinical depression and anxiety symptoms in older people, which could progress to clinical conditions. Neurofeedback training based on electroencephalography (EEG) or functional near-infrared spectroscopy (fNIRS) teaches individuals to self-regulate different aspects of brain activity and induce neurocognitive improvements. This proposed project will examine whether prefrontal EEG and fNIRS neurofeedback training programmes can enhance the mood and cognition of older adults with subclinical depression and anxiety.
详细描述
Background:
Subclinical symptoms of depression and anxiety are common in older adults, with some estimates indicating that these symptoms are present in 10-52% of community-dwelling older adults. Some studies have shown that older adults with subclinical depression and anxiety are more likely than those with low levels of relevant symptoms to be diagnosed with affective disorders and mild cognitive impairment or dementia later in life. Thus, interventions for older people with elevated subclinical symptoms of depression and anxiety are crucial for preventing affective disorders and dementia late in life. During negative emotional experiences, the prefrontal cortex (PFC) plays a pivotal role in downregulating activity. PFC dysfunction may cause different mood and anxiety symptoms.
Neurofeedback training is a non-pharmaceutical neurorehabilitation technique that can potentially improve prefrontal function and enhance mental health and cognitive functions. This technique uses sensory feedback to teach individuals to self-regulate specific brain activities, with the goal of inducing long-term neuroplasticity and functional improvements. Traditionally, neurofeedback training has been conducted using EEG, and much research has applied such training interventions for the treatment of a variety of psychiatric disorders. In recent years, interest in using fNIRS to deliver neurofeedback training has grown. The underlying mechanism of such training with fNIRS is different from that of training with EEG. Compared with EEG, fNIRS has a lower temporal resolution but a higher spatial resolution and is more resilient to movement artifacts. In addition, one recent study showed that patients with social anxiety disorder had reduced anxiety symptoms after fNIRS neurofeedback training.
Research Plan and Methodology:
Design: This proposed project has been designed in accordance with current consensus on the reporting and experimental design of clinical and cognitive-behavioural neurofeedback studies. The participants will be randomly and equally assigned to one of three neurofeedback training groups: (1) sham, (2) EEG, and (3) fNIRS. Each participant will complete a neurophysiological assessment (1) before, (2) immediately after, and (3) 1 month after intervention.
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
- Double (Participant, Investigator)
盲法说明
During each training session, a cap adjusted to the participant's head size will be used to mount the EEG and fNIRS sensors. The hardware setup will be the same for all groups to ensure that both the participant and the experimenter are blinded to the training group.
入排标准
- 年龄范围
- 60 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(i) age of 60-79 years;
- •(ii) right-handedness as assessed using the short form of the Edinburgh Handedness Inventory (Veale, 2014);
- •(iii) a moderate or higher score on at least one of the depression and anxiety subscales (but not necessarily both) of the Depression Anxiety Stress Scale-21 (DASS-21), which has been shown to yield reliable and valid scores;
- •(iv) no history of neurological or psychiatric disorder;
- •(v) no history of traumatic brain injury requiring hospitalisation;
- •(vi) not currently using psychotropic medication;
- •(vii) ability to read Traditional Chinese text;
- •(viii) normal or corrected-to-normal vision; and
- •(ix) a score of at least 19 on the Hong Kong Montreal Cognitive Assessment
排除标准
- •does not fulfill any of the above criteria
研究组 & 干预措施
Sham Group
During training, participants will be asked to follow the instructions on a computer screen and complete five rounds of task. Each round starts with a 30-s rest phase followed by 4.5 min of self-regulation phase. At the rest phase, a fixed cross will appear onscreen, and participants will be instructed to sit still and relax. At the regulation phase, they will be asked to make the person smile (as an intrinsic social reward) but without tips. The intensity of smiling will be manipulated by morphing photographs of a neutral and a happy face and will represent the increase in either frontal alpha asymmetry or frontal oxyhaemoglobin asymmetry. The values at the moment will be compared against the baseline. Participants will undergo a 3-min rest period before and after each training session to track changes in resting-state brain activity. In the sham condition, participants will receive visual feedback based on pre-recordings and/or other participants' recordings.
干预措施: Baseline Training (Other)
fNIRS Group
During training, participants will be asked to follow the instructions on a computer screen and complete five rounds of task. Each round starts with a 30-s rest phase followed by 4.5 min of self-regulation phase. At the rest phase, a fixed cross will appear onscreen, and participants will be instructed to sit still and relax. At the regulation phase, they will be asked to make the person smile (as an intrinsic social reward) but without tips. The intensity of smiling will be manipulated by morphing photographs of a neutral and a happy face and will represent the increase in either frontal alpha asymmetry or frontal oxyhaemoglobin asymmetry. The values at the moment will be compared against the baseline. Participants will undergo a 3-min rest period before and after each training session to track changes in resting-state brain activity. In the fNIRS condition, participants will receive visual feedback based on their own fNIRS recordings.
干预措施: fNIRS (Device)
EEG Group
During training, participants will be asked to follow the instructions on a computer screen and complete five rounds of task. Each round starts with a 30-s rest phase followed by 4.5 min of self-regulation phase. At the rest phase, a fixed cross will appear onscreen, and participants will be instructed to sit still and relax. At the regulation phase, they will be asked to make the person smile (as an intrinsic social reward) but without tips. The intensity of smiling will be manipulated by morphing photographs of a neutral and a happy face and will represent the increase in either frontal alpha asymmetry or frontal oxyhaemoglobin asymmetry. The values at the moment will be compared against the baseline. Participants will undergo a 3-min rest period before and after each training session to track changes in resting-state brain activity. In the EEG condition, participants will receive visual feedback based on their own EEG recordings.
干预措施: EEG (Device)
结局指标
主要结局
Mood symptoms (post)
时间窗: Within 1 week before the first training session, and within 1 week after the last training session
Change in the HADS depression score (The Hospital Anxiety and Depression Scale (HADS) depression score has a minimum value of 0 and a maximum value of 21. Higher scores indicate a worse outcome. A score of 0-7 indicates normal, 8-10 indicates mild depression, 11-14 indicates borderline depression, and 15-21 indicates depression.)
Mood symptoms (follow-up)
时间窗: Within 1 week before the first training session, and within 1 month after the last training session
Change in the HADS depression score at follow up (The Hospital Anxiety and Depression Scale (HADS) depression score has a minimum value of 0 and a maximum value of 21. Higher scores indicate a worse outcome. A score of 0-7 indicates normal, 8-10 indicates mild depression, 11-14 indicates borderline depression, and 15-21 indicates depression.)
Anxiety symptoms (post)
时间窗: Within 1 week before the first training session, and within 1 week after the last training session
Change in the HADS anxiety score (The Hospital Anxiety and Depression Scale (HADS) anxiety score has a minimum value of 0 and a maximum value of 21. Higher scores indicate a worse outcome. A score of 0-7 indicates normal, 8-10 indicates mild anxiety, 11-14 indicates borderline anxiety, and 15-21 indicates anxiety.)
Anxiety symptoms (follow-up)
时间窗: Within 1 week before the first training session, and within 1 month after the last training session
Change in the HADS anxiety score at follow-up (The Hospital Anxiety and Depression Scale (HADS) anxiety score has a minimum value of 0 and a maximum value of 21. Higher scores indicate a worse outcome. A score of 0-7 indicates normal, 8-10 indicates mild anxiety, 11-14 indicates borderline anxiety, and 15-21 indicates anxiety.)
次要结局
- n-back (post; fNIRS)(Within 1 week before the first training session, and within 1 week after the last training session)
- n-back (follow-up; fNIRS)(Within 1 week before the first training session, and within 1 month after the last training session)
- Stroop (post; RT)(Within 1 week before the first training session, and within 1 week after the last training session)
- Stroop (follow-up; RT)(Within 1 week before the first training session, and within 1 month after the last training session)
- Stroop (post; accuracy)(Within 1 week before the first training session, and within 1 week after the last training session)
- Stroop (follow-up; accuracy)(Within 1 week before the first training session, and within 1 month after the last training session)
- Stroop (follow-up; fNIRS)(Within 1 week before the first training session, and within 1 month after the last training session)
- n-back (post; RT)(Within 1 week before the first training session, and within 1 week after the last training session)
- n-back (post; accuracy)(Within 1 week before the first training session, and within 1 week after the last training session)
- Stroop (post; fNIRS)(Within 1 week before the first training session, and within 1 week after the last training session)
- Stroop (post; EEG)(Within 1 week before the first training session, and within 1 week after the last training session)
- n-back (post; EEG)(Within 1 week before the first training session, and within 1 week after the last training session)
- n-back (follow-up; EEG)(Within 1 week before the first training session, and within 1 month after the last training session)
- Stroop (follow-up; EEG)(Within 1 week before the first training session, and within 1 month after the last training session)
- n-back (follow-up; RT)(Within 1 week before the first training session, and within 1 month after the last training session)
- n-back (follow-up; accuracy)(Within 1 week before the first training session, and within 1 month after the last training session)