Effects of Transcranial Direct Current Stimulation on Loneliness in Older Adults With Depression: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change in loneliness levels from baseline measured by the UCLA Loneliness Scale from baseline
研究概览
简要总结
High loneliness is prevalent among older adults and is a significant risk factor for major depression and low recovery rates in patients. Current interventions for loneliness are limited. Previous research has demonstrated a link between loneliness, negative social emotions, and reduced resting-state functional connectivity in the lateral prefrontal cortex (LPFC) and the default mode network (DMN). Transcranial direct current stimulation (tDCS) has shown promise in enhancing emotional regulation and connectivity, potentially alleviating loneliness in older adults with depression.
详细描述
Loneliness is a pervasive issue among older adults, significantly increasing the risk of major depression and contributing to low recovery rates in affected individuals. Despite its widespread impact, current interventions aimed at alleviating loneliness remain limited and often ineffective. Research has revealed a strong connection between feelings of loneliness, negative social emotions, and decreased resting-state functional connectivity in key brain regions, particularly the lateral prefrontal cortex (LPFC) and the default mode network (DMN). These findings suggest that the neural underpinnings of loneliness may be targeted to improve emotional well-being.
Transcranial direct current stimulation (tDCS) emerges as a promising intervention in this context, as it has been shown to enhance emotional regulation and improve functional connectivity within these neural networks. By applying low electrical currents to specific brain areas, tDCS may help mitigate feelings of loneliness, thereby fostering a greater sense of social connection among older adults with depression.
Objectives Evaluate the Effects of Repeated tDCS on Loneliness Levels: This trial aims to systematically assess how repeated sessions of tDCS influence loneliness in older adults with major depressive disorder. By comparing these groups, we hope to understand the differential impacts of tDCS on loneliness, taking into account the potential confounding effects of depression.
Elucidate the Neuro-Emotional Mechanisms: A key objective is to uncover the neuro-emotional mechanisms that underlie the effects of tDCS on loneliness. This involves examining changes in neural activity and connectivity patterns in the LPFC and DMN, as well as tracking shifts in negative social emotions that may accompany improvements in loneliness. Understanding these mechanisms could enhance the efficacy of tDCS as an intervention.
Develop Predictive Models for Individualized Treatment Outcomes: Another important aim of this trial is to create predictive models that utilize neuro-emotional data to tailor treatment approaches for individuals. By identifying specific neural and emotional markers that correlate with positive outcomes from tDCS, we can move toward more personalized interventions, potentially improving recovery rates and overall mental health in older adults with depression facing loneliness.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •High loneliness (UCLA Loneliness Scale > 43).
- •Diagnosis of major depressive disorder confirmed by the Structured Clinical Interview for DSM-5 Disorders.
- •absence of suicidal ideation (Hamilton Depression Scale item 3 score ≤ 1).
排除标准
- •Severe neurological diseases.
- •Bipolar disorder, schizophrenia, addiction, or impulse control disorders.
- •Contraindications for tDCS or MRI (e.g., metal implants).
- •Presence of suicidal ideation.
结局指标
主要结局
Change in loneliness levels from baseline measured by the UCLA Loneliness Scale from baseline
时间窗: 2 weeks, 1.5 months and 3.5 months
This outcome measures the change in loneliness levels among participants, assessed using the UCLA Loneliness Scale. Evaluations will occur at baseline, 1 month, and 3 months post-intervention (after the two weeks of intervention, the same as below) to determine the effectiveness of the tDCS intervention on reducing feelings of loneliness in patients with depression.
次要结局
- Change in Emotional and Motivational Ratings from baseline(2 weeks, 1.5 months and 3.5 months)
- changes in Social Participation Levels from baseline(2 weeks, 1.5 months and 3.5 months)
- changes in Social Motivation from baseline(2 weeks, 1.5 months and 3.5 months)
- changes in Social Network from baseline(2 weeks, 1.5 months and 3.5 months)
- changes in Emotional Regulation from baseline(2 weeks, 1.5 months and 3.5 months)
- changes in Affective Traits from baseline(2 weeks, 1.5 months and 3.5 months)
- changes in Reward Sensitivity from baseline(2 weeks, 1.5 months and 3.5 months)
- changes in Depressive Symptoms from baseline(2 weeks, 1.5 months and 3.5 months)
- changes in Resting-State Functional Connectivity from baseline(2 weeks, 1.5 months and 3.5 months)
- Change in social support from baseline(2 weeks, 1.5 months and 3.5 months)
- changes in Emotion Coping from baseline(2 weeks, 1.5 months and 3.5 months)
- changes in Incentive-Driven Behavioural Tendencies from baseline(2 weeks, 1.5 months and 3.5 months)
- changes in Anhedonia level from baseline(2 weeks, 1.5 months and 3.5 months)
研究者
Kangguang Lin
Director of the Department of Affective disorders
Guangzhou Psychiatric Hospital