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Biomarkers of Environment Sensitivity

29 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

125

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Ungheria
      • Budapest, Ungheria, 1089
        • Semmelweis University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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:

    1. the participant is currently asymptomatic or exhibits only mild residual symptoms,
    2. the disorder does not cause significant functional impairment or distress, and
    3. 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Stress handling training
Comportamentale: Williams Life Skills Stress Management Training
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.
Comparatore placebo: Placebo intervention
Comportamentale: Placebo Intervention
Seminars about stress biology structured similarly as in the active arm.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in negative psychological symptoms
Lasso di tempo: 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)
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.
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)
Change in somatic symptoms
Lasso di tempo: 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)
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
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)
Change in positive psychological indicators
Lasso di tempo: 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)
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.
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)
Change in coping strategies
Lasso di tempo: 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)
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.
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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Semmelweis University

Collaboratori

National Research, Development and Innovation Office, Hungary

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 novembre 2022

Completamento primario (Effettivo)

31 marzo 2026

Completamento dello studio (Stimato)

31 ottobre 2026

Date di iscrizione allo studio

Primo inviato

11 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 maggio 2026

Primo Inserito (Effettivo)

18 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • K143391

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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