Biomarkers of Environment Sensitivity

NCT07594080 | Active Not Recruiting

• 1 other identifier: K143391
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress; Mental Health and General Well-being

Outcome Measures

Primary Outcomes (4)

• Change in negative psychological symptoms

  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 the baseline to the follow-up (after intervention).

• Change in somatic symptoms

  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 to follow-up (after intervention).

• Change in positive psychological indicators

  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 to follow-up (after intervention).

• Change in coping strategies

  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 to follow-up (after intervention).

Study Arms (2)

Stress handling training

EXPERIMENTAL

Behavioral: Williams Life Skills Stress Management Training

Placebo intervention

PLACEBO COMPARATOR

Behavioral: Placebo Intervention

Interventions

Williams Life Skills Stress Management Training BEHAVIORAL

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.

Stress handling training

Placebo Intervention BEHAVIORAL

Seminars about stress biology structured similarly as in the active arm.

Placebo intervention

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Stable mental state
• Right-handed
• Not taking regular medication (exception: in females, the use of hormonal contraceptives and oral iron supplements is permitted)

You may not qualify if:

• 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

Sponsors & Collaborators

• Semmelweis University: lead
• National Research, Development and Innovation Office, Hungary: collaborator

Study Sites (1)

Semmelweis University

Budapest, 1089, Hungary

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start: November 1, 2022
• Primary Completion: March 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)