Interventions for the Wellbeing of Students at the University of Helsinki
NCT Number: NCT06542029
Acronym: INSIGHT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Well-Being, Psychological
Interventions: BEHAVIORAL: Groups 4 Health (G4H)|BEHAVIORAL: The study psychologists' group intervention|BEHAVIORAL: Towards better well-being and studying -online course
Sponsor: University of Helsinki
Collaborators: Strategic Research Council, Finland|University of Eastern Finland|Finnish Institute for Health and Welfare
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-03-20
Completion Date: 2026-07-31
Locations: University of Helsinki, Helsinki, Uusimaa, 00014, Finland

Summary:
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.

Primary Outcome Measures: Loneliness, Loneliness is measured with the 4 and 8-item short forms of the revised University of California, Los Angeles Loneliness Scale (ULS-4 and ULS-8, response options: 1=never, 2=rarely, 3=sometimes, 4=often, lower score means better outcome)., 1) Before the intervention, 2) During the intervention (week 3), 3) immediately after the intervention, 4) one month follow-up, 5) three months follow-up|Active group memberships, Multiple group memberships are assessed with the 4-item Exeter Identity Transition Scale (response options: 1 = strongly disagree, 7 = strongly agree, higher score means better outcome)., 1) Before the intervention, 3) immediately after the intervention 4) one month follow-up, 5) three months follow-up|Mental well-being, Mental well-being is assessed with the 7-item Short Warwick-Edinburgh Mental Wellbeing Scale (response options: 1=not at all, 2=rarely, 3=occasionally, 4=often, 5=all the time, higher score means better outcome)., 1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up|General well-being, General well-being is assessed with the 14-item General Population version of the Clinical Outcomes in Routine Evaluation (response options: 0=not at all, 1=only occasionally, 2=sometimes, 3=often, 4=most of/all of the time, lower score means better outcome)., 1) Before the intervention, 3) immediately after the intervention 4) one month follow-up, 5) three months follow-up|Depression, Symptoms of depression are assessed with the 9-item Patient Health Questionnaire (response options: 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day, lower score means better outcome)., 1) Before the intervention, 3) immediately after the intervention 4) one month follow-up, 5) three months follow-up|Anxiety, Symptoms of anxiety are assessed with the 7-item Generalized Anxiety Disorder Questionnaire (response options: 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day, lower score means better outcome)., 1) Before the intervention, 3) immediately after the intervention 4) one month follow-up, 5) three months follow-up|Social anxiety, Social anxiety is assessed with the 3-item Mini Social Phobia Inventory (response options: 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day, lower score means better outcome)., 1) Before the intervention, 3) immediately after the intervention 4) one month follow-up, 5) three months follow-up
Secondary Outcome Measures: Study credits, Overall accumulated study credit data is gathered from the UH registries. These data will be used both as measures of effectiveness of the interventions and to account for the confounders in the statistical analyses., 1 year before the intervention, 1 year after the intervention|Grade point average, One year grade point average is gathered from the UH registries. These data will be used both as measures of effectiveness of the interventions and to account for the confounders in the statistical analyses., 1 year before the intervention, 1 year after the intervention|Weighted grade point average, Weighted grade point average is determined by the grades of each course weighted by the number of credits gained for it., 1 year before the intervention, 1 year after the intervention|Health-related quality of life, Health-related quality of life is measured with the Euro Quality of Life - 5 dimension - 5 level questionnaire (EQ-5D-5L). The measure has 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) comprising of five statements of which the respondent can choose the option that best describes their situation. Higher score means better outcome. This measure is used to calculate the cost-effectiveness of the interventions., 1) Before the intervention, 2) immediately after the intervention, 3) three months follow-up|Use of Social and Health care services, The use of social and health care services for mental health is measured with a self-report questionnaire (medications, health care appointments, hospitalization, counseling). The use of health care services will be monetarized by using Finnish national unit costs. This measure is used to calculate the cost-effectiveness of the interventions., 1) Before the intervention, 2) immediately after the intervention, 3) three months follow-up|Time used by facilitators, The time used for planning, executing, and assessing the G4H sessions is reported by the facilitators. This measure is used to calculate the cost-effectiveness of the interventions., Immediately after each intervention session, during 8 weeks
Other Outcome Measures: Mood, Mood is measured with scale from 0 (extremely bad mood) to 7 (extremely good mood), 1) Before the intervention, 2) During the intervention (week 3), 3) immediately after the intervention, 4) one month follow-up, 5) three months follow-up|Identification with the intervention, Identification with the intervention group is assessed with the Single-Item Social Identification -measure (response options: 1 = fully disagree, 7 = fully agree, higher score means better outcome)., During intervention (week 3)|Participant adherence, The number of participants consented vs the number of participants completing the intervention, attendance rate of individual sessions, Immediately after each intervention session, during 8 weeks|Facilitator's fidelity to the manual, To monitor fidelity to the G4H manual, the facilitators of the G4H groups will complete a short checklist at the end of each session to determine compliance to the protocol., Immediately after each intervention session, during 8 weeks|Participants' Working alliance, Participants' experience of working alliance is assessed with the 12-item Working Alliance Inventory Short and Revised (response options: 1 = never, 2 = rarely, 3 = occasionally, 4 = sometimes, 5 = often, 6 = very often, 7 = always, 3 subscales: goal, task, bond, higher score means better outcome), During intervention (week 3)|Facilitators' Working alliance, Facilitators' working alliance is assessed with an 18-item version of the Therapist Working Alliance Inventory Short Form (response options: 1 = never, 2 = rarely, 3 = occasionally, 4 = sometimes, 5 = often, 6 = very often, 7 = always, 3 subscales: goal, task, bond, higher score means better outcome), During intervention (week 3)