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Physiological, Hormonal, and DNA-based Mechanisms of Psychosocial Stress and Therapeutic Effect

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2025 to Sep 12, 2025
    • Site details revised
    v3
  2. Secondary endpoints revised (16)
    • Study description expanded, about 12 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this trial is to learn if the Groups 4 Health (G4H) intervention is effective in supporting student well-being at the University of Helsinki. It will also learn about the factors that may influence the efficacy of the intervention (such as facilitators characteristics, stress physiology and changes in gene expression). The main questions it aims to answer are: 1. Is the G4H intervention effective and cost-effective in supporting student well-being? 2. To what extent participants' physiological, hormonal, or molecular characteristics mediate the therapeutic effect of the G4H 3. To what extent participants' genotype moderates the effect of the G4H 4. To what extent facilitators' characteristics mediate or moderate the effect of the G4H Data is collected from both the intervention participants and the facilitators. The G4H facilitators will: * Facilitate the G4H intervention. * Fill in questionnaires and provide physiological and molecular measurements before, during, and after the G4H intervention. The G4H participants will: * Participate in the G4H intervention. * Fill in questionnaires and provide physiological, hormonal and molecular measurements before, during, and after the G4H intervention.
Trial Details
NCT Number NCT07152652
Lead Sponsor University of Helsinki
Collaborators: Strategic Research Council, Finland, University of Eastern Finland, Finnish Institute for Health and Welfare, Finnish Cultural Foundation
Conditions
(from sponsor)		 Well-Being, Psychological, Loneliness
Related terms Anxiety Disorders, Depression, Psychological Well-Being, Social Isolation
Enrollment 148 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov