En Longitudinell Observationsstudie om Unga Individers Psykiska hälsa i Sverige
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Change in well-being
研究概览
简要总结
The goal of this observational study is to increase our knowledge about the mental health of young individuals and to establish a valid and comprehensive method for assessing mental health in young individuals (15-29 years) that can improve our capacity to promote mental health and address mental health problems.
The specific aims of the proposed project are: 1) To determine the extent and course of mental health in young men and women over a two-year period and discern the added value of multimodal data to assess and predict mental health problems. 2) To demonstrate the feasibility of different assessment methods of mental health in young individuals.
Participants will be able to provide:
- Survey data - mental health outcome measures are used to assess mental well-being and mental health problems, and sociodemographic and individual health data are collected to explore potential confounders with the primary outcomes.
- Behavioral testing - online/remote behavioral assessments such as approach-avoidance conflict, emotional regulation, risk-taking-attitude and cognitive tests.
- National register data - sociodemographic data including age, country of birth, education, school absence, sickness absence and income, inpatient (hospital) and outpatient specialist care, information on e.g. psychiatric conditions and pain conditions and psychiatric care and use of psychotropic medication.
- Blood-based biological marker - monitoring of about 800 biomarkers, carefully selected to target the most important metabolic pathways, including steroid-, hormone-, neurotransmitter- and lipid regulation.
- Passive data by digital phenotyping - automatically collected data from for example smartphone sensors and activity logs.
- App- and survey metadata - app usage, when a survey was opened, time taken to answer separate measures and questions, completion of full survey, and any changes made in survey responses.
Researchers will compare 3 different assessment protocols, with participants providing data at different time points, this in order to see demonstrate feasibility and methods for future studies on mental health in young individuals. Establishment of feasibility is done by collecting data on: recruitment rate, adherence and acceptance of study procedures including mode of data collection.
详细描述
In Sweden, reports show an increase in mental health problems of young people, in particular of young women. This increase is poorly understood, calling for more rigorous studies to clarify extent and severity of the problems, but also, to inform practices on how to adequately assess youth mental health.
The purpose of this project is to increase our knowledge about the mental health of young women and men and to establish a valid and comprehensive method for assessing mental health in young individuals that can improve our capacity to promote mental health and address mental health problems. A multimodal data approach is applied, comprising a feasibility study on methods of assessment of mental health in young individuals.
The specific aims of the proposed project are: 1) To determine the extent and course of mental health in young women and men over a two-year period and discern the added value of multimodal data to assess and predict mental health problems. 2) To demonstrate the feasibility of different assessment methods of mental health in young women and men. Establishment of feasibility is done by collecting data on: recruitment rate, adherence and acceptance of study procedures including mode of data collection.
There is a common opinion in Sweden and internationally that mental health problems have increased over the past decades. More research is needed to understand this proposed increase in mental health problems and to clarify if the reports reflect a genuine deterioration in mental health. Existing studies have been criticized for not being able to provide reliable estimates of mental health problems due to heterogeneity in study designs and limitations including lack of use of established, comprehensive measures. The national surveys that indicate a deterioration of mental health in young women in Sweden rely on reports from single questions. Although less respondent burden, the validity and reliability of using single questions to assess concepts such as anxiety and depression can be disputed. Moreover, existing studies provide cross-sectional point estimates rather than prospective time lines, which generally result in more accurate and reliable data.
Traditional methodologies with sole reliance on self-reported data to provide accurate and reliable estimates to better understand mental health of young women may not be the way forward. For instance, metabolomics biomarkers taken from for example blood or urine have gained interest for its ability to screen new and unsuspected pathways involved in psychiatric disorders, and fear conditioning and extinction protocols as well as behavioural testing of e.g. avoidance and distress tolerance have shown promise in detecting and predicting mental health. Combining self-report data with information from such other data sources presents a promising approach, yet the use of multimodal data is an understudied area in mental health research. Moreover, with the ubiquity of smartphones along with advances in technology, it is now possible to use digital devices such as smartphones to assess and track certain behaviours, which makes it possible to address some of the drawbacks of traditional assessment methods. Behavioural real-time data on e.g., participant's symptoms, functions, and social environment in nonclinical settings collected from digital devices holds considerable potential for detecting, understanding and predicting psychiatric conditions, mood disorders, and depressive symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 29 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age at recruitment
- •ownership of smartphone
排除标准
- 未提供
结局指标
主要结局
Change in well-being
时间窗: Baseline, 6 months, 1 year, 1.5 years, 2 year for Group 2
Self-report: Well-Being Index (WHO-5). Swedish version. 5 items ranging from 0 ='at no time', to 5 ='all the time'. The 5 items are summed to a score ranging from 0 to 25, 0 representing worst possible and 25 representing best possible quality of life.
Change in depressive symptoms
时间窗: Baseline, 6 months, 1 year, 1.5 years, 2 year for Group 2
Self-report: Patient Health Questionnaire - 9 (PHQ-9+1), Swedish version. 9 items ranging from 0 ='not at all', to 3 ='almost every day'. 1 item ranging from 0 ='no difficulties, to 3 = 'extreme difficulties'. The first 9 items are summed to a sum score ranging from 0 to 27, where: 0-4 = no signs of depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, 20-27 = severe depression. Item 10 is reported as a single item where high scores indicate high interference with daily function.
Change in anxiety symptoms
时间窗: Baseline, 6 months, 1 year, 1.5 years, 2 year for Group 2
Self-report: Generalised Anxiety Disorder (GAD-7). Swedish version. 7 items ranging from 0 ='not at all', to 3 ='almost every day'. 1 item ranging from 0 ='no difficulties, to 3 = 'extreme difficulties'. 1 item ranging from 0 ='not at all, to 3 = 'very disturbing'. The first 7 items are summed to a sum score ranging from 0 to 21, where: 0-4 = no signs of anxiety, 5-9 = mild GAD, 10-14 = moderate GAD, 15-21 = severe GAD. Item 8 is reported as a single item where higher score means higher interference.
次要结局
- Change in Psychological Flexibility(Baseline, 6 months, 1 year, 1.5 years, 2 year for Group 2)
- Behavioral test, emotional regulation(2 year for Group 1, 2, 3)
- Change in perceived meaningfulness of leisure(Baseline, 6 months, 1 year, 1.5 years, 2 year for Group 2)
- Change in sleep(Baseline, 6 months, 1 year, 1.5 years, 2 year for Group 2)
- Change in psychological flexibility(Baseline, 1 year, 2 year for Group 1 and 3)
- Change in effortful control(Baseline, 6 months, 1 year, 1.5 years, 2 year for Group 2)
- Social factors(2 year for Group 1, 2, 3)
- Change in emotional well-being(Baseline, 6 months, 1 year, 1.5 years, 2 year for Group 2)
- Change in stress(Baseline, 1 year, 2 year for Group 1 and 3)
- Explorative identification of biomarkers(6 months for Group 2, 3)
- Behavioral test, influence of ambiguity(2 year for Group 1, 2, 3)
- Change in curiosity(Baseline, 6 months, 1 year, 1.5 years, 2 year for Group 2)
- Individual health data(2 year for Group 1, 2, 3)
- Health behaviours(2 year for Group 1, 2, 3)
- Behavioral test, approach-avoidance conflict(2 year for Group 1, 2, 3)
- Behavioral test, risk-taking(2 year for Group 1, 2, 3)
- Change in emotion regulation(Baseline, 6 months, 1 year, 1.5 years, 2 year for Group 2)
- Sociodemographic data(2 year for Group 1, 2, 3)
