Personalised Transcranial Direct Current Stimulation to Reduce Daily Loneliness in People With Subthreshold Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Changes in self-reported loneliness
研究概览
简要总结
This study evaluates the effects of multi-session transcranial direct current stimulation on loneliness, mood and depressiveness in people with subthreshold depression.
详细描述
Depression-prone individuals will be invited and allocated to three groups, either the personalised transcranial direct current stimulation (tDCS) group, the conventional tDCS group, or the sham control group. After screening and at baseline prior to the tDCS sessions, participants will complete tests and questionnaires on depression symptoms, loneliness and mood. Eligible participants will also be invited to receive functional magnetic resonance imaging (MRI) in a 3-Tesla MRI scanner. There will be a maximum of 10 sessions to be completed after the screening and baseline measures. For both personalised tDCS group and the conventional tDCS group, tDCS with 2 milliampere (mA) intensity will be delivered for 20 minutes in each session. For sham control group, the protocol will be similar, except that the stimulation only happens in the first 30 seconds in each session. Especially for participants allocated to the personalised tDCS group, the stimulation site for each individual in this group may vary, depending on their brain activations and connectivity. The anodal stimulation sites for participants allocated to the conventional tDCS group and the sham control group will be F3 within the left DLPFC. Immediately after and also 3-months after completing all the tDCS sessions, participants will be invited to complete again tests and questionnaires on depressive symptoms in addition to loneliness and mood. Eligible participants will also be invited to receive functional MRI scanning in the 3T MRI scanner again. Participants will also be prompted to self-report daily their loneliness and mood levels throughout the study.
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, 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
- •No histories of learning impairment, major psychiatric disorders including Major Depressive Disorder or neurological disorders
- •At least primary school education
- •Subthreshold depression
排除标准
- •On medication or treatments within 2 weeks prior to the beginning of the study that would affect the individual's brain, cognitive and affective functions
研究组 & 干预措施
Personalised tDCS group
Participants who are assigned to the personalised group will receive anodal tDCS over a individualized stimulation site.
干预措施: Personalized Experimental Transcranial Direct Current Stimulation (tDCS) (Device)
Conventional tDCS group
Participants who are assigned to the Conventional group will receive anodal tDCS over F3.
干预措施: Conventional Experimental Transcranial Direct Current Stimulation (tDCS) (Device)
Sham control group
Participants who are assigned to the Conventional group will receive sham tDCS. The active stimulation will be delivered for the first 30 seconds only.
干预措施: Sham Transcranial Direct Current Stimulation (tDCS) (Device)
结局指标
主要结局
Changes in self-reported loneliness
时间窗: From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session
Loneliness is assessed based on the University of California, Los Angeles (UCLA) loneliness scale and single item, in which higher scores indicate greater degrees of loneliness.
次要结局
- Changes in depressive symptoms(From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session)
- Changes in anxiety symptoms(From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session)
- Changes in self-reported mood(From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session)
- Changes in brain activation and connectivity(From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session)
研究者
WONG Man Lok Nichol
Assistant Professor
Education University of Hong Kong