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临床试验/NCT07594080
NCT07594080进行中(未招募)不适用

Genetic and Brain Correlates of Sensitivity to Positive and Negative Environment: New Predictive Markers of Stress Management Intervention Outcome

Semmelweis University1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2022年11月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
125
试验地点
1

研究概览

简要总结

Most of the common mental disorders are heritable to a certain extent but environmental factors have an important role influencing whether the disorder will develop or not. These factors can be negative (e.g. loss of job or death of a loved one) that increase the risk of disorders but also positive (e.g. friends that provide support in need or doing sport regularly) that prevent the development of symptoms. This study investigates whether those who are sensitive to negative impacts may be also more sensitive to positive circumstances. If this is true, improving the environment of these people, for example offering psychotherapy, may help them more than to those who are not sensitive to the environment. More than 500 000 participants' genetic data is used to investigate which genetic factors are associated with sensitivity to environment. This information will be used to determine genetic sensitivity to environment in independent participants who went through functional magnetic resonance brain imaging. Therefore, the study will examine whether sensitive and non-sensitive peoples' brain respond differently to positive and negative stimuli. Finally, tests will determine how sensitivity to environment influences the effectiveness of an intervention that psychologists use to improve stress coping in young adults. This method aims to identify biomarkers to predict the effectiveness of this intervention. In summary, the study will enhance the understanding of why some people are more sensitive to environmental influences and how this information can be utilized to select the most suitable therapy for them.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Stable mental state
  • Right-handed
  • Not taking regular medication (exception: in females, the use of hormonal contraceptives and oral iron supplements is permitted)

排除标准

  • Current somatic or neurological disorder, or a history of such conditions that may affect neurophysiological functioning (poor physical health may influence mental state and thereby affect the results)
  • Current or past major psychiatric disorder based on medical history or according to DSM-5 diagnostic criteria, with the exception of unipolar depression, anxiety disorders, and eating disorders, provided that:
  • the participant is currently asymptomatic or exhibits only mild residual symptoms,
  • the disorder does not cause significant functional impairment or distress, and
  • there is no absolute indication for pharmacological treatment
  • Risky or endangering behavior, or lack of adequate insight into illness
  • Regular use of medication (exception: in females, the use of hormonal contraceptives and oral iron supplements is permitted)
  • Alcoholism or other substance abuse
  • Contraindications for fMRI participation: Metal implants that may compromise participant safety during scanning or cause artifacts in image acquisition
  • Pregnancy

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Juhász Gabriella

Full Professor

Semmelweis University

研究点 (1)

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