Biomarkers of Environment Sensitivity
29 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
125
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Budapest, Hungría, 1089
- Semmelweis University
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Stress handling 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.
|
|
Comparador de placebos: Placebo intervention
|
Seminars about stress biology structured similarly as in the active arm.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in negative psychological symptoms
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de noviembre de 2022
Finalización primaria (Actual)
31 de marzo de 2026
Finalización del estudio (Estimado)
31 de octubre de 2026
Fechas de registro del estudio
Enviado por primera vez
11 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
11 de mayo de 2026
Publicado por primera vez (Actual)
18 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- K143391
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .