Utilizing Transcranial Direct Current Stimulation (tDCS) to Alleviate Subthreshold Depression Via Distinct Positive and Negative Emotion Pathways
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Depressive symptoms
研究概览
简要总结
The goal of this clinical trial is to investigate how transcranial direct current stimulation (tDCS) affects emotion functions in young adults aged 18-35 from the local community, including both male and female participants. The main question[s] it aims to answer are:
- Does tDCS improve emotional functions, such as mood regulation and motivation, in individuals with subthreshold depression (StD)?
- Can tDCS enhance emotional regulation compared to a sham stimulation (placebo)?
Researchers will compare participants receiving tDCS on either the left dorsolateral prefrontal cortex (lDLPFC) or right ventrolateral prefrontal cortex (rVLPFC) with those receiving sham stimulation to see if tDCS has a stronger effect on emotional functions.
Participants will:
- Complete online and in-person screening to assess depressive symptoms using the Chinese version of the Beck Depression Inventory II (C-BDI-II) and be selected based on their depressive symptoms (C-BDI-II score ≥ 13).
- Be randomly assigned to one of three groups: lDLPFC tDCS, rVLPFC tDCS, or Sham control group (1:1:1 ratio).
- Receive 10 sessions of tDCS or Sham tDCS over 2 weeks, with each session lasting 20 minutes.
- Complete assessments at baseline, post-intervention, 1-month follow-up, and 3-month follow-up, with each assessment lasting 2-2.5 hours. This includes questionnaires and perform emotional and cognitive tasks.
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)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-35 years
- •Fluency in Cantonese or Mandarin
- •Normal or corrected-to-normal vision and hearing
- •IQ > 75% Quantile in Raven's SPM
- •At least 9 years of formal education
- •Right-handedness
排除标准
- •Past or current major physical illness or psychiatric disorders
- •Use of psychotropic medication in the past 6 months
- •Pregnancy (for women)
- •Any condition that prevents safe tDCS use (e.g., brain injury, implants)
- •Previous participation in neuromodulation in the past 3 months
研究组 & 干预措施
IDLPFC tDCS
This intervention is a 20 minutes per session, two-week tDCS neuromodulation of IDLPFC region (anode: F3, cathode: FP2) designed to reduce depressive symptoms via enhancing positive emotion functions, thereby reducing anhedonia.
干预措施: Transcranial Direct Current Stimulation (Device)
rVLPFC tDCS
This intervention is a 20 minutes per session, two-week tDCS neuromodulation of rVLPFC region (anode: F6, cathode: FP1) designed to reduce depressive symptoms via regulating negative emotion functions, thereby reducing depressed mood.
干预措施: Transcranial Direct Current Stimulation (Device)
Sham tDCS
This is a 20 minutes per session, two-week Sham comparator of IDLPFC/rVLPFC region, participants will receive tDCS for 30 seconds at either IDLPFC/rVLPFC at the beginning of each session to stimulate real neuromodulation.
干预措施: Sham tDCS (Device)
结局指标
主要结局
Depressive symptoms
时间窗: Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105)
The Beck Depression Inventory-II Chinese Version measures change in depressive symptoms. The total score range is 0-63, higher score indicates more severe depressive symptoms.
次要结局
- Anhedonia severity(Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105))
- Affective trait(Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105))
- Anhedonia symptoms(Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105))
- Behavioural motivation trait(Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105))
- Reward sensitivity(Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105))
- Emotion regulation function(Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105))
- Coping to adversity(Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105))
- Apathy symptom(Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105))
- Perceived loneliness(Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105))
- Stress level(Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105))
- Emotion ratings of words(Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105))
- Instrumental behavioural motivation(Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105))
- Emotional inhibition control(Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105))
- Working memory(Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105))
- Cognitive control function(Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105))
研究者
Zhengxi Shao
Associate Professor
The University of Hong Kong