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临床试验/NCT05501951
NCT05501951Unknown不适用

Reduce High-risk Behaviours Under Chronic Stress Via tDCS-induced Neural Plasticity

LI Cheng0 个研究点目标入组 255 人开始时间: 2022年10月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
255
主要终点
Changes in risk taking behavior

研究概览

简要总结

The persistent political conflicts and COVID-19 pandemic have led to elevated chronic stress levels in Hong Kong, with far-reaching and profound negative impacts on the citizen's mental health. An important pathway via which chronic stress negatively impacts health is through promoting high-risk behaviours, such as addiction, suicide, and antisocial acts. Therefore, testing means to break the association between chronic stress and high-risk behaviour is essential to reducing the adverse consequences of stress and promoting stress resilience. The transcranial direct current stimulation (tDCS) may be a viable method for reducing risky tendency in high-stress individuals, through modulating brain functions and plasticity. Although single-session tDCS has been shown to reliably reduce risky decision making and behaviours acutely, its efficacy over extended periods of time has not been demonstrated, particularly among non-clinical samples. Being able to show that tDCS could lead to long-lasting reduction of risky tendency is necessary for promoting the wide application of this method in therapeutic settings. In this project, we aim to conduct a randomised control trial to systematically and comprehensively test whether 10 sessions of tDCS on either the dorsolateral prefrontal cortex or the orbitofrontal cortex would lead to reduction in risky tendency not only immediately after treatment, but also at 1 month and 3 months after treatment.

Participants will be healthy male and female adults (21-40 years old) under relatively high levels of chronic stress, as selected from an online survey prior to the study.

Participants will be randomly allocated to one of 3 treatment groups: DLPFC tDCS, OFC tDCS, and sham control. At baseline, participants will complete several risk-taking assessments, including an established computerised task that measures both risk taking and a cognitive bias that was shown to increase irrational risky tendency (illusion of control), an established questionnaire that measures risky decision making in real-life scenarios, and a scale measuring past engagement in common risky activities.

Participants will also complete various personality and mood questionnaires, along with assessments on important cognitive abilities. We hypothesized that both DLPFC and OFC tDCS would reduce risk taking across the 3 timepoints, but the effect of DLPFC tDCS would be mediated by reduction in cognitive bias, whereas that of OFC tDCS would be mediated by increase in inhibition functions. These hypotheses will be tested by linear mixed models and mediation analyses. Additional exploratory analyses also test whether the tDCS effect would be moderated by relevant personality factors such as impulsivity.

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
21 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 21-40 years;
  • Fluent in reading and writing Chinese (Cantonese or Mandarin);
  • Right-handed as assessed with the Edinburgh Handedness Inventory;
  • Normal or corrected-to-normal vision and hearing;
  • IQ>90 as assessed with the Test of Nonverbal Intelligence, 4th edition (TONI-IV)

排除标准

  • Past or present physical illness, organic brain disorder, traumatic brain injury, addiction, impulse control disorder, psychotic disorder, affective disorder, or any other major neurological or psychological condition;
  • First-degree relative with past or present major psychological disorder or suicidal behaviour;
  • Intake of psychotropic medication or any other medication that may affect cognition in the 6 months preceding the study day;
  • (For women) being pregnant;
  • any contraindication for tDCS, such as having a cerebral implant or history (either personal or family) of seizure. The psychological conditions will be assessed using the Structured Clinical Interview for DSM-5 Disorders-Clinician Version (SCID-5-CV).

结局指标

主要结局

Changes in risk taking behavior

时间窗: Baseline; 1-month follow up; 3-month follow up

Changes in risk taking will be assessed using the IoC card gambling task

次要结局

未报告次要终点

研究者

发起方
LI Cheng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

LI Cheng

Postdoctoral fellow

The University of Hong Kong

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