Biomarkers of Environment Sensitivity
2026年5月29日 更新者：Dr. Juhász Gabriella、Semmelweis University
Genetic and Brain Correlates of Sensitivity to Positive and Negative Environment: New Predictive Markers of Stress Management Intervention Outcome
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.
研究概览
地位
主动，不招人
条件
研究类型
介入性
注册 (实际的)
125
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Budapest、匈牙利、1089
- Semmelweis University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- Stable mental state
- Right-handed
- Not taking regular medication (exception: in females, the use of hormonal contraceptives and oral iron supplements is permitted)
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Stress handling training
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The Hungarian version (http://www.eletkeszsegek.hu) of Williams LifeSkills experience (Williams RB, Williams VP.
Adaptation and implementation of an evidence-based behavioral medicine program in diverse global settings: The Williams LifeSkills experience.
Transl Behav Med.
2011 Jun;1(2):303-12.
doi: 10.1007/s13142-011-0030-6.) was used as intervention.
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安慰剂比较：Placebo intervention
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Seminars about stress biology structured similarly as in the active arm.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in negative psychological symptoms
大体时间：From baseline at enrollment to after the first exam period (approximately 3-5 months), after the second exam period (approximately 7-10 months), and after the third exam period (approximately 14-17 months)
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Changes in Depression Anxiety Stress Scales (DASS-21) score is expected (Lovibond PF & Lovibond SH (1995) Behav Res Ther 33(3):335-343.).
The scale involves the assessment of depression, anxiety, and stress-with a total score range between 0 and 21 for each subscale, which is multiplied by 2 for final scoring (0 to 42 per scale).
For the Depression scale, scores between 10 and 13 mean mild depression, 14 to 20 moderate depression, 21 to 27 severe depression, and 28 or above extremely severe depression.
For the Anxiety scale, scores between 8 and 9 mean mild anxiety, 10 to 14 moderate anxiety, 15 to 19 severe anxiety, and 20 or above extremely severe anxiety.
For the Stress scale, scores between 15 and 18 mean mild stress, 19 to 25 moderate stress, 26 to 33 severe stress, and 34 or above extremely severe stress.
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From baseline at enrollment to after the first exam period (approximately 3-5 months), after the second exam period (approximately 7-10 months), and after the third exam period (approximately 14-17 months)
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Change in somatic symptoms
大体时间：From baseline at enrollment to after the first exam period (approximately 3-5 months), after the second exam period (approximately 7-10 months), and after the third exam period (approximately 14-17 months)
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Changes in Patient Health Questionnaire-15 (PHQ-15) scores (Kroenke K, Spitzer RL, & Williams JBW (2002) The PHQ-15: Validity of a new measure for evaluating the severity of somatic symptoms.
Psychosom Med 64(2):258-266.) is expected.
The scale involves the assessment of somatic symptom severity and the potential presence of somatization, with a score range between 0 and 30.
Scores between 5 and 9 mean mild somatic symptom severity, 10 to 14 moderate somatic symptom severity, and 15 or above severe somatic symptom severity
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From baseline at enrollment to after the first exam period (approximately 3-5 months), after the second exam period (approximately 7-10 months), and after the third exam period (approximately 14-17 months)
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Change in positive psychological indicators
大体时间：From baseline at enrollment to after the first exam period (approximately 3-5 months), after the second exam period (approximately 7-10 months), and after the third exam period (approximately 14-17 months)
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Changes in Mental Health Continuum Short Form (MHC-SF) (Keyes CLM (2006) Mental health in adolescence: Is America's youth flourishing?
Am J Orthopsychiat 76(3):395-402.) is expected.
The scale involves the assessment of positive mental health across three domains-emotional, social, and psychological well-being-with a total continuous score range between 0 and 70, where higher scores indicate greater overall well-being.
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From baseline at enrollment to after the first exam period (approximately 3-5 months), after the second exam period (approximately 7-10 months), and after the third exam period (approximately 14-17 months)
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Change in coping strategies
大体时间：From baseline at enrollment to after the first exam period (approximately 3-5 months), after the second exam period (approximately 7-10 months), and after the third exam period (approximately 14-17 months)
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Changes in Coping Inventory for Stressful Situations (CISS-48) (Endler NS, Parker JDA, & Butcher JN (1993) A Factor-Analytic Study of Coping Styles and the Mmpi-2 Content Scales.
J Clin Psychol 49(4):523-527.) is expected.
The scale involves the assessment of an individual's multidimensional coping styles in response to stress, with each of its three primary subscales (yielding a subscale score range between 16 and 80).
Scores are converted to standardized T-scores (M=50, SD=10) compared against gender- and age-specific norm groups.
Higher comparative scores on the Task-Oriented coping subscale mean a dominant tendency to utilize purposeful, problem-focused action.
Higher scores on the Emotion-Oriented subscale mean a dominant tendency to focus on emotional distress, self-blame, or somatic responses.
Higher scores on the Avoidance-Oriented subscale mean a dominant tendency to cognitively or behaviorally disengage.
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From baseline at enrollment to after the first exam period (approximately 3-5 months), after the second exam period (approximately 7-10 months), and after the third exam period (approximately 14-17 months)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年11月1日
初级完成 (实际的)
2026年3月31日
研究完成 (估计的)
2026年10月31日
研究注册日期
首次提交
2026年5月11日
首先提交符合 QC 标准的
2026年5月11日
首次发布 (实际的)
2026年5月18日
研究记录更新
最后更新发布 (实际的)
2026年6月2日
上次提交的符合 QC 标准的更新
2026年5月29日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.