Clinical trial NCT06542029: Interventions for the Wellbeing of Students At the University of Helsinki
Official title: Groups 4 Health (Ryhmät Kuntoon) for Mental Well-being: a Feasibility and Controlled Effectiveness Study At the University of Helsinki
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Well-Being, Psychological
Keywords: University Students
Group Intervention
Mental Health
Loneliness
Social Isolation
Anxiety
Depression
Social Anxiety
Social Cohesion
Equality
Inclusion
Motivation
Controlled study
Groups 4 Health
Adherence
Acceptance and Commitment Therapy
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Strategic Research Council, Finland
name: University of Eastern Finland
name: Finnish Institute for Health and Welfare
First posted: 2024-08-07
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a parallel-arm non-randomized controlled clinical trial. The participants are assigned to the different intervention arms based on their preference (the students can sign up for an intervention of their choosing).
Primary purpose: TREATMENT

Brief 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.

Detailed description: Groups for health (G4H) is a manualized brief intervention based on social identity theory aiming to improve mental well-being by promoting social connectedness and belonging as well as reducing loneliness by building the participants' social identity capital in the context of group experience.

The Effectiveness of the G4H intervention has been studied in two Australian randomized controlled trials (RCT) as well as in one Australian controlled experiment. The RCT studies showed that G4H decreased loneliness and social anxiety and increased group memberships significantly more than treatment as usual and that in comparison with cognitive-behavioral therapy (CBT), both interventions reduced loneliness as effectively in the beginning of the intervention period, but the G4H group showed continued reduction in loneliness at the end of the intervention period and in the follow-up. Both interventions reduced depressive symptoms significantly and there were no differences between G4H and CBT. In all three controlled studies on the effects of G4H, inclusion criteria for the study were low mood and loneliness.

At present research on the effectiveness of G4H outside Australia is lacking and the cost-effectiveness of the G4H intervention or determinants of intervention effectiveness have not been evaluated. Consequently, this study focuses on the feasibility, effectiveness, and cost-effectiveness of the G4H among the University of Helsinki (UH) students in Finland. Moreover, students will not be excluded based on lack of loneliness or symptoms of depression.

The participants are students at the UH who have either; A) applied for three brief interventions for students' well-being: "Ryhmät kuntoon" -course (G4H at the UH), groups facilitated by the study psychologists, or online course for students' well-being (active intervention groups), or B) students who are not attending to any active interventions for mental well-being or promotion of studying skills (no-intervention control group). The students will be recruited for the active intervention groups and no-intervention group by email, website, and social media advertisements circulated by the UH media and communications services, communications services at the faculties, student health services, and student organizations. The interventions will be organized at the UH and are free for the UH students.

Data on the outcome measures is collected before and during the intervention as well as in 1- and 3-months follow-ups. Appropriate statistical methods including linear mixed model analyses will be used to study the effectiveness of the G4H intervention.

In addition to the outcome measures, data on the participants' and facilitators' background will be collected. The participant background questionnaire is filled out before the intervention and it consists of information on age, gender, birth date, mother tongue, marital status, household composition, residential situation, employment status, education, income, subjective health, readiness to attend to the intervention, social support, academic skills, and situational intrinsic and extrinsic motivation. Data gathered from UH registries include information on study rights (faculty, degree programs, fields of study) and their starting years, on active and passive registration, completed degrees, and information on learning and studies, such as approaches to learning, experiences of the teaching-learning environment, stress, and experiences of study-related burnout during studies and work during studies (HowULearn and HowUStudy questionnaires). This data is gathered to account for these factors in the statistical analyses and to analyze if these factors influence the effectiveness and cost-effectiveness of the intervention.

To investigate how facilitators' individual professional and personal characteristics may predict intervention process and effectiveness, G4H facilitators will fill self-report measures both before and during the interventions. Before initiating the intervention, facilitators will fill questionnaires related to personality traits (Extra-Short Five questionnaire), attachment style (Experiences in Close Relationships -questionnaire), and self-experiences in close personal relationships (Trainee Background Information Form). After the week 3 session, the facilitators' experiences of their current skillfulness, difficulties, and emotions in group work is measured based on an abbreviated version of the self-reported Trainee Current Practice Report. In addition, the facilitators' experiences of the group working alliance will be surveyed, based on a modified version of the Therapist Working Alliance Inventory Short Form.

In the collection of the quantitative data, both paper-and-pencil and electronic versions of the questionnaires will be used. Those in the active intervention groups will fill in the data as part of the sessions during the interventions or in the frequency of the sessions if the questionnaires are provided electronically and those in the no-intervention group will fill-in the questionnaires based on the email reminders of the electronic data collection system (time interval between reminders resembling interval between sessions in the active intervention groups). Data is collected before the intervention, during the intervention (week 3), immediately after the intervention and in one- and three-months follow-ups.

In addition to the quantitative data collection the investigators will explore the challenges and possibilities identified in the G4H-intervention regarding inclusion and equality. Three methods of data collection are used: 1) participant observations, 2) interviews with G4H participants and facilitators and 3) focus groups with young people who belong to minorities. In this sub-study, the aim is to examine challenges and possibilities identified in the G4H-intervention regarding inclusion and equality and whether G4H promotes long-term inclusion and equality among the participants.

Participant observations are conducted in the meetings of the G4H group and interviews are conducted with a subset of facilitators and intervention participants in the end of the intervention period. The follow-up interviews will be conducted 6 months, 12 months and 3 years after the first interview. The facilitators and participants of G4H will be mailed information about the study and an informed consent will be acquired before the first session. The participant observation focuses on the interaction in the groups and the experiences of facilitators and participants, in order to gain knowledge about how the groups work, what kinds of issues they deal with and especially how inclusion and equality are accomplished in the groups (are there minority participants, can participants influence the themes dealt with in the groups, or is inclusion and equality taken into account in some other ways in the groups). Following the ethnographic research tradition, the researcher takes part in the activities of the groups instead of observing them from the outside. Depending on their preferences, the study participants (both facilitators and participants in the groups) will be interviewed in a group, in pairs or individually, in facilities located outside the university (for example in a study room of a local library).

In addition, focus groups are arranged with young people belonging to minority groups with increased risk of marginalization or mental health problems. In the focus groups, young people are asked to comment on the design/description of G4H in terms of equality and inclusion, with the goal of enhancing inclusivity by listening to their views on the interventions and accumulation knowledge on the fit between the interventions and their specific needs. The focus groups target young people belonging to sexual and/or gender minorities, young people with immigrant background and young people with disabilities. These groups represent youth minorities with a high risk of loneliness. To date, research on their experiences of different services is lacking. All the interviews will be tape-recorded and later transcribed.

Written informed consent is gathered from all participants. The participants who have given their consent have the option to withdraw from the study at any point. Students who are currently undergoing other (mental health) treatment will not be interviewed to avoid causing them further stress.

Eligibility criteria: Inclusion criteria

* Adult (age 18 and above)
* Student in the University of Helsinki, Finland
* Able to speak/read Finnish, Swedish, or English

Exclusion criteria:

- None

Primary outcomes:
measure: Loneliness
timeFrame: 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
measure: Depression
timeFrame: 1) Before the intervention, 3) immediately after the intervention 4) one month follow-up, 5) three months follow-up
Secondary outcomes:
measure: Active group memberships
timeFrame: 1) Before the intervention, 3) immediately after the intervention 4) one month follow-up, 5) three months follow-up
measure: Mental well-being
timeFrame: 1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up
measure: General well-being
timeFrame: 1) Before the intervention, 3) immediately after the intervention 4) one month follow-up, 5) three months follow-up
measure: Anxiety
timeFrame: 1) Before the intervention, 3) immediately after the intervention 4) one month follow-up, 5) three months follow-up
measure: Social anxiety
timeFrame: 1) Before the intervention, 3) immediately after the intervention 4) one month follow-up, 5) three months follow-u
measure: Health-related quality of life
timeFrame: 1) Before the intervention, 2) immediately after the intervention, 3) three months follow-up
measure: Use of social and health care services
timeFrame: 1) Before the intervention, 2) immediately after the intervention, 3) three months follow-up
measure: Time used by facilitators
timeFrame: Immediately after each intervention session, during 8 weeks
measure: Study credits
timeFrame: 1 year before the intervention, 1 year after the intervention
measure: Grade point average
timeFrame: 1 year before the intervention, 1 year after the intervention
measure: Weighted grade point average
timeFrame: 1 year before the intervention, 1 year after the intervention
Other outcomes:
measure: Mood
timeFrame: 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
measure: Identification with the intervention
timeFrame: During intervention (week 3)
measure: Participant adherence
timeFrame: Immediately after each intervention session, during 8 weeks
measure: Facilitator's fidelity to the manual
timeFrame: Immediately after each intervention session, during 8 weeks
measure: Participants' Working alliance
timeFrame: During intervention (week 3)
measure: Facilitators' Working alliance
timeFrame: During intervention (week 3)
Locations:
city: Helsinki
country: Finland
facility: University of Helsinki
state: Uusimaa
Study officials:
affiliation: University of Helsinki
name: Jari M Lahti, PhD
role: PRINCIPAL_INVESTIGATOR
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