Physiological, Hormonal, and DNA-based Mechanisms of Psychosocial Stress and Therapeutic Effect
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Loneliness
研究概览
简要总结
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:
- Is the G4H intervention effective and cost-effective in supporting student well-being?
- To what extent participants' physiological, hormonal, or molecular characteristics mediate the therapeutic effect of the G4H
- To what extent participants' genotype moderates the effect of the G4H
- 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.
详细描述
This study is a randomized waitlist-controlled trial for investigating the efficacy and cost-efficacy of Groups 4 Health (G4H) brief psychosocial intervention for loneliness among the students at the University of Helsinki. Furthermore, several biological and psychosocial mechanisms that may exert the effects of psychosocial stress and therapeutic change are studied. In addition to various psychosocial factors, the mechanisms include genetic factors and epigenetic alterations, hypothalamic-pituitary axis (HPA) activity (cortisol), and parasympathetic (heart rate variability) and sympathetic (alpha amylase) function of the autonomic nervous system (ANS).
This trial will investigate:
- The efficacy and cost-efficacy of the G4H in a wait-list randomized controlled trial (RCT)
- To what extent participants' physiological, hormonal or molecular measures of ANS, cortisol, alpha amylase, and Deoxyribonucleic Acid methylation (DNAm) mediate the therapeutic effect of the G4H.
- To what extent participants' genotype moderates the effects of the G4H.
- To what extent facilitators' characteristics mediates or moderates the effect of the G4H.
The participants will be randomized to start the G4H immediately after randomization or after the waitlist-period of 19 weeks (7 weeks active G4H + 3 months follow-up). The G4H includes five facilitated group sessions and will be delivered over a 7-week period. Data is collected before, during, and after the intervention, as well as in 1-, 3-, and 12-month follow-ups. The waitlist control group does not provide 12-months follow-up data, as they receive the intervention after the 19 weeks waitlist-period.
METHODS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (age 18 and above)
- •Student in the University of Helsinki, Finland
- •Able to speak/read Finnish, Swedish, or English
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, 6) 12 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, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up, 5) 12-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).
Active group memberships
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, 6) 12-months follow-up
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).
Mental well-being
时间窗: 1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up, 5) 12-months follow-up
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).
General well-being
时间窗: 1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up, 5) 12-months follow-up
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).
Anxiety
时间窗: 1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up, 5) 12-months follow-up
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).
Social anxiety
时间窗: 1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up, 5) 12-months follow-up
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).
次要结局
- Perceived Stress(1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up, 5) 12-months follow-up)
- Self- and other-compassion(1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up, 5) 12-months follow-up)
- 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 accumulated over one year(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)
- Study burnout risk(1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up, 5) 12-months follow-up)
- Sleep quality(1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up, 5) 12-months follow-up)
- Salivary cortisol(The participants provide the samples on two consecutive days 1) before the intervention 2) after the intervention, and 3) at 3-months follow-up. The sampling times are 0, 30, 45, and 60 minutes after awakening (4 samples per day).)
- Salivary alpha-amylase(The participants provide the samples on two consecutive days 1) before the intervention 2) after the intervention, and 3) at 3-months follow-up. The sampling times are 0, 30, 45, and 60 minutes after awakening (4 samples per day). The alpha amylase awake)
- Daily positive and negative affect(1) Before the intervention, 2) During the intervention, 3) immediately after the intervention, 4) three months follow-up])
- Daily health-related information(1) Before the intervention, 2) During the intervention, 3) immediately after the intervention, 4) three months follow-up)
- Daily momentary loneliness(1) Before the intervention, 2) During the intervention, 3) immediately after the intervention, 4) three months follow-up)
- Daily satisfaction with life(1) Before the intervention, 2) During the intervention, 3) immediately after the intervention, 4) three months follow-up)
- Perceived Stress(1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up, 5) 12-months follow-up)
- Self- and other-compassion(1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up, 5) 12-months follow-up)
- Daily health-related information(1) Before the intervention, 2) During the intervention, 3) immediately after the intervention, 4) three months follow-up)
- Daily momentary loneliness(1) Before the intervention, 2) During the intervention, 3) immediately after the intervention, 4) three months follow-up)
- Daily satisfaction with life(1) Before the intervention, 2) During the intervention, 3) immediately after the intervention, 4) three months follow-up)
研究者
Jari Lahti
Professor
University of Helsinki