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.
調査の概要
状態
積極的、募集していない
研究の種類
介入
入学 (実際)
125
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Budapest、ハンガリー、1089
- Semmelweis University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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プラセボコンパレーター：Placebo intervention
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Seminars about stress biology structured similarly as in the active arm.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in negative psychological symptoms
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2022年11月1日
一次修了 (実際)
2026年3月31日
研究の完了 (推定)
2026年10月31日
試験登録日
最初に提出
2026年5月11日
QC基準を満たした最初の提出物
2026年5月11日
最初の投稿 (実際)
2026年5月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月2日
QC基準を満たした最後の更新が送信されました
2026年5月29日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。