Groups 4 Health (Ryhmät Kuntoon) for Mental Well-being: a Feasibility and Controlled Effectiveness Study at the University of Helsinki
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Loneliness
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Loneliness
时间窗: 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
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).
Depression
时间窗: 1) Before the intervention, 3) immediately after the intervention 4) one month follow-up, 5) three months follow-up
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).
次要结局
- Active group memberships(1) Before the intervention, 3) immediately after the intervention 4) one month follow-up, 5) three months follow-up)
- Mental well-being(1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up)
- General well-being(1) Before the intervention, 3) immediately after the intervention 4) one month follow-up, 5) three months follow-up)
- Anxiety(1) Before the intervention, 3) immediately after the intervention 4) one month follow-up, 5) three months follow-up)
- Social anxiety(1) Before the intervention, 3) immediately after the intervention 4) one month follow-up, 5) three months follow-u)
- Health-related quality of life(1) Before the intervention, 2) immediately after the intervention, 3) three months follow-up)
- Use of social and health care services(1) Before the intervention, 2) immediately after the intervention, 3) three months follow-up)
- Time used by facilitators(Immediately after each intervention session, during 8 weeks)
- Study credits(1 year before the intervention, 1 year after the intervention)
- Grade point average(1 year before the intervention, 1 year after the intervention)
- Weighted grade point average(1 year before the intervention, 1 year after the intervention)
研究者
Jari Lahti
Professor
University of Helsinki