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Interventions for the Wellbeing of Students At the University of Helsinki

Study acronym: INSIGHT
StatusUnknown
PhaseNot applicable
Started
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Record status
This record was last updated September 19, 2024 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Notable Primary endpoints: 7 to 2
    • Secondary endpoints: 6 to 11
    v3
  3. Minor Study title shortened, about 1 wordv2
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 psychological, social, and health consequences of psychological ill-being, particularly loneliness, are well-documented among students, which underlines the importance of providing adequate support. Groups 4 Health (G4H) is a promising psychosocial group intervention focused on improving well-being by supporting social connectedness and belonging. In earlier Australian studies G4H has decreased loneliness and social anxiety and increased group memberships significantly more than treatment as usual. When compared to cognitive behavioral therapy G4H has showed continued reduction in the participants' loneliness at the end of the intervention period and in the follow-up. Research on the G4H intervention's effectiveness outside Australia and research on the intervention's cost-effectiveness is lacking. Therefore, this clinical study investigates the feasibility, effectiveness, and cost-effectiveness of the G4H among the University of Helsinki students in Finland. The effectiveness and cost-effectiveness of the G4H will be compared to two other active intervention groups: the well-being groups facilitated by the study psychologists at the University of Helsinki and an online course for students' well-being. Effectiveness will also be compared to students who do not participate in any well-being courses or interventions. The investigators hypothesize that all the active intervention groups promote student well-being. Questionnaires and University of Helsinki registry data will be gathered before and after the interventions to evaluate the effectiveness and cost-effectiveness of the interventions. The factors that influence the intervention's effectiveness and cost-effectiveness will also be studied. In addition to these research questions, qualitative methods are used to explore the challenges and possibilities identified in the G4H-intervention regarding inclusion and equality.
Trial Details
NCT Number NCT06542029
Lead Sponsor University of Helsinki
Collaborators: Strategic Research Council, Finland, University of Eastern Finland, Finnish Institute for Health and Welfare
Conditions
(from sponsor)
Well-Being, Psychological
Related terms Anxiety Disorders, Depression, Psychological Well-Being, Social Isolation
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov