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Biomarkers of Environment Sensitivity

29 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

125

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Węgry
      • Budapest, Węgry, 1089
        • Semmelweis University

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Stress handling training
Behawioralne: 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.
Komparator placebo: Placebo intervention
Behawioralne: Placebo Intervention
Seminars about stress biology structured similarly as in the active arm.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in negative psychological symptoms
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Semmelweis University

Współpracownicy

National Research, Development and Innovation Office, Hungary

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 listopada 2022

Zakończenie podstawowe (Rzeczywisty)

31 marca 2026

Ukończenie studiów (Szacowany)

31 października 2026

Daty rejestracji na studia

Pierwszy przesłany

11 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 maja 2026

Pierwszy wysłany (Rzeczywisty)

18 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

2 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • K143391

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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