A Study on Young Individuals' Mental Health in Sweden
NCT Number: NCT06490120
Acronym: UPIC
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mental Health Issue|Depression, Anxiety|Well-Being, Psychological
Interventions: OTHER: sampling method
Sponsor: Uppsala University
Collaborators: The Swedish Research Council
Sex: ALL
Age: CHILD, ADULT
Enrollment: 3000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-12
Completion Date: 2027-12-31
Locations: Uppsala University, Uppsala, Sweden

Summary:
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.

Primary Outcome Measures: Change in anxiety symptoms, 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., Baseline, 1 year, 2 year for Group 1 and 3|Change in anxiety symptoms, 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., Baseline, 6 months, 1 year, 1.5 years, 2 year for Group 2|Change in depressive symptoms, 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., Baseline, 1 year, 2 year for Group 1 and 3|Change in depressive symptoms, 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., Baseline, 6 months, 1 year, 1.5 years, 2 year for Group 2|Change in well-being, 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., Baseline, 1 year, 2 year for Group 1 and 3|Change in well-being, 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., Baseline, 6 months, 1 year, 1.5 years, 2 year for Group 2
Secondary Outcome Measures: Change in emotional well-being, Self-report: Mental Health Continuum Short Form (MHC-SF). Swedish version. 14 items which assesses how often a statement was true during the past two weeks, reported on a 6-point Likert scale ranging from 0 "never" to 5 "everyday". Statements include emotional, social, and psychological aspects of well-being. Items are summed, yielding a total score ranging from 0 to 70. The total scale score will be used for the assessment of overall mental well-being with higher scores indicating greater levels of positive well-being., Baseline, 1 year, 2 year for Group 1 and 3|Change in emotional well-being, Self-report: Mental Health Continuum Short Form (MHC-SF). Swedish version. 14 items which assesses how often a statement was true during the past two weeks, reported on a 6-point Likert scale ranging from 0 "never" to 5 "everyday". Statements include emotional, social, and psychological aspects of well-being. Items are summed, yielding a total score ranging from 0 to 70. The total scale score will be used for the assessment of overall mental well-being with higher scores indicating greater levels of positive well-being., Baseline, 6 months, 1 year, 1.5 years, 2 year for Group 2|Change in stress, Self-report: Perceived Stress Scale (PSS-10). Swedish version. 10 item ranging from 0 ='never' to 4 ='very often'. Scores for item 4, 5, 7 and 8 need to be reversed (0=4, 1=3, 2=2, 1=4) and all summed to a score ranging 0 to 40. Higher scores indicate higher level of perceived stress., Baseline, 6 months, 1 year, 1.5 years, 2 year for Group 2|Change in stress, Self-report: Perceived Stress Scale (PSS-10). Swedish version. 10 item ranging from 0 ='never' to 4 ='very often'. Scores for item 4, 5, 7 and 8 need to be reversed (0=4, 1=3, 2=2, 1=4) and all summed to a score ranging 0 to 40. Higher scores indicate higher level of perceived stress., Baseline, 1 year, 2 year for Group 1 and 3|Change in sleep, Self-report: The insomnia severity index (ISI). Swedish version. The ISI comprises 7 items that assess current (i.e., preceding 2 weeks) sleep problems. The first three items evaluate the severity of sleep onset, sleep maintenance, and early morning awakening problems. Subsequent items assess current sleep problem, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and amount of worry due to the current sleep problem. Items are rated on a five-point Likert scale ('0' representing none or not at all and '4' representing very much). Total scores range from 0 to 28, with higher combined scores indicating worse insomnia severity., Baseline, 1 year, 2 year for Group 1 and 3|Change in sleep, Self-report: The insomnia severity index (ISI). Swedish version. The ISI comprises 7 items that assess current (i.e., preceding 2 weeks) sleep problems. The first three items evaluate the severity of sleep onset, sleep maintenance, and early morning awakening problems. Subsequent items assess current sleep problem, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and amount of worry due to the current sleep problem. Items are rated on a five-point Likert scale ('0' representing none or not at all and '4' representing very much). Total scores range from 0 to 28, with higher combined scores indicating worse insomnia severity., Baseline, 6 months, 1 year, 1.5 years, 2 year for Group 2|Change in psychological flexibility, Self-report: Selected items from the Multidimensional Psychological Flexibility Inventory (MPFI). Swedish version. 12 items where rate how often they experience each statement during the last 2 weeks, with responses given on a 6-point scale ranging from never true (1) to always true (6)., Baseline, 1 year, 2 year for Group 1 and 3|Change in Psychological Flexibility, Self-report: Selected items from the Multidimensional Psychological Flexibility Inventory (MPFI). Swedish version. 12 items where rate how often they experience each statement during the last 2 weeks, with responses given on a 6-point scale ranging from never true (1) to always true (6)., Baseline, 6 months, 1 year, 1.5 years, 2 year for Group 2|Change in effortful control, Self-report: The Adult Temperament Questionnaire (ATQ). Swedish version. 19 items where Each item is rated on a 7-point Likert scale, ranging from 1 = 'extremely untrue of you' to 7 = 'extremely true of you'., Baseline, 1 year, 2 year for Group 1 and 3|Change in effortful control, Self-report: The Adult Temperament Questionnaire (ATQ). Swedish version. 19 items where Each item is rated on a 7-point Likert scale, ranging from 1 = 'extremely untrue of you' to 7 = 'extremely true of you'., Baseline, 6 months, 1 year, 1.5 years, 2 year for Group 2|Change in emotion regulation, Self-report: The Adolescents' Emotion Regulation Strategies Questionnaire-Extended (AERSQ-E). Swedish version. 23 items with each item rated on a 5-point scale, ranging from 1 = 'very rarely/never' to 5 = 'very often/always'., Baseline, 1 year, 2 year for Group 1 and 3|Change in emotion regulation, Self-report: The Adolescents' Emotion Regulation Strategies Questionnaire-Extended (AERSQ-E). Swedish version. 23 items with each item rated on a 5-point scale, ranging from 1 = 'very rarely/never' to 5 = 'very often/always'., Baseline, 6 months, 1 year, 1.5 years, 2 year for Group 2|Individual health data, Self-report: height, weight, sexual health, menstrual bleeding pattern, physical health, psychological diagnosis and treatments., Baseline for Group 1, 2, 3|Individual health data, Self-report: height, weight, sexual health, menstrual bleeding pattern, physical health, psychological diagnosis and treatments., 6 months for Group 2|Individual health data, Self-report: height, weight, sexual health, menstrual bleeding pattern, physical health, psychological diagnosis and treatments., 1 year for Group 1, 2, 3|Individual health data, Self-report: height, weight, sexual health, menstrual bleeding pattern, physical health, psychological diagnosis and treatments., 1.5 year Group 2|Individual health data, Self-report: height, weight, sexual health, menstrual bleeding pattern, physical health, psychological diagnosis and treatments., 2 year for Group 1, 2, 3|Health behaviours, Self-report: physical activity, habits related to smoking, alcohol use, caffein, food and fluid intake. Social media use and leisure time., Baseline for Group 1, 2, 3|Health behaviours, Self-report: physical activity, habits related to smoking, alcohol use, caffein, food and fluid intake. Social media use and leisure time., 6 months for Group 2|Health behaviours, Self-report: physical activity, habits related to smoking, alcohol use, caffein, food and fluid intake. Social media use and leisure time., 1 year for Group 1, 2, 3|Health behaviours, Self-report: physical activity, habits related to smoking, alcohol use, caffein, food and fluid intake. Social media use and leisure time., 1.5 year Group 2|Health behaviours, Self-report: physical activity, habits related to smoking, alcohol use, caffein, food and fluid intake. Social media use and leisure time., 2 year for Group 1, 2, 3|Sociodemographic data, Self-report: country of birth, gender, sexual identity, living situation, employment, education., Baseline for Group 1, 2, 3|Sociodemographic data, Self-report: country of birth, gender, sexual identity, living situation, employment, education., 6 months for Group 2|Sociodemographic data, Self-report: country of birth, gender, sexual identity, living situation, employment, education., 1 year for Group 1, 2, 3|Sociodemographic data, Self-report: country of birth, gender, sexual identity, living situation, employment, education., 1.5 year Group 2|Sociodemographic data, Self report: country of birth, gender, sexual identity, living situation, employment, education., 2 year for Group 1, 2, 3|Social factors, Self-report: sense of community and belonging, and experience of violence and harassment, Baseline for Group 1, 2, 3|Social factors, Self-report: sense of community and belonging, and experience of violence and harassment, 6 months for Group 2|Social factors, Selfreport: sense of community and belonging, and experience of violence and harassment, 1 year for Group 1, 2, 3|Social factors, Self-report: sense of community and belonging, and experience of violence and harassment, 1.5 year Group 2|Social factors, Self-report: sense of community and belonging, and experience of violence and harassment, 2 year for Group 1, 2, 3|Explorative identification of biomarkers, Optional at home blood sample, extraction and analysis of about 800 biomarkers and ratios of metabolic pathways, including steroid-, hormone-, neurotransmitter- and lipid regulation, Baseline for Group 2, 3|Explorative identification of biomarkers, At home blood sample, extraction and analysis of about 800 biomarkers and ratios of metabolic pathways, including steroid-, hormone-, neurotransmitter- and lipid regulation, 6 months for Group 2, 3|Behavioral test, approach-avoidance conflict, Data from online, remote behavioural tests. Measures of basic psychological mechanisms of importance for mental health such as approach-avoidance conflict., Baseline for Group 1, 2, 3|Behavioral test, emotional regulation, Data from online, remote behavioural tests. Measures of basic psychological mechanisms of importance for mental health such as emotional regulation., Baseline for Group 1, 2, 3|Behavioral test, risk-taking, Data from online, remote behavioural tests. Measures of basic psychological mechanisms of importance for mental health such as risk-taking., Baseline for Group 1, 2, 3|Behavioral test, influence of ambiguity, Data from online, remote behavioural tests. Measures of basic psychological mechanisms of importance for mental health such as influence of ambiguity., Baseline for Group 1, 2, 3|Behavioral test, approach-avoidance conflict, Data from online, remote behavioural tests. Measures of basic psychological mechanisms of importance for mental health such as approach-avoidance conflict., 1 year for Group 1, 2, 3|Behavioral test, emotional regulation, Data from online, remote behavioural tests. Measures of basic psychological mechanisms of importance for mental health such as emotional regulation., 1 year for Group 1, 2, 3|Behavioral test, risk-taking, Data from online, remote behavioural tests. Measures of basic psychological mechanisms of importance for mental health such as risk-taking., 1 year for Group 1, 2, 3|Behavioral test, influence of ambiguity, Data from online, remote behavioural tests. Measures of basic psychological mechanisms of importance for mental health such as influence of ambiguity., 1 year for Group 1, 2, 3|Behavioral test, approach-avoidance conflict, Data from online, remote behavioural tests. Measures of basic psychological mechanisms of importance for mental health such as approach-avoidance conflict., 2 year for Group 1, 2, 3|Behavioral test, emotional regulation, Data from online, remote behavioural tests. Measures of basic psychological mechanisms of importance for mental health such as emotional regulation., 2 year for Group 1, 2, 3|Behavioral test, risk-taking, Data from online, remote behavioural tests. Measures of basic psychological mechanisms of importance for mental health such as risk-taking., 2 year for Group 1, 2, 3|Behavioral test, influence of ambiguity, Data from online, remote behavioural tests. Measures of basic psychological mechanisms of importance for mental health such as influence of ambiguity., 2 year for Group 1, 2, 3|Change in curiosity, Self Report: Five-Dimensional Curiosity Scale Revised (5DCR). Swedish version. 7 selected items from Five-Dimensional Curiosity Scale Revised (5DCR). 7-point scale ranging from 1 = 'does not describe me' to 7 = 'describes me completely'., Baseline, 1 year, 2 year for Group 1 and 3|Change in curiosity, Self-report: Five-Dimensional Curiosity Scale Revised (5DCR). Swedish version. 7 selected items from Five-Dimensional Curiosity Scale Revised (5DCR). 7-point scale ranging from 1 = 'does not describe me' to 7 = 'describes me completely'., Baseline, 6 months, 1 year, 1.5 years, 2 year for Group 2|Change in perceived meaningfulness of leisure, Self-report: 1 item. 4-point scale ranging from not at all meaningful (0) to absolutely meaningful (4)., Baseline, 1 year, 2 year for Group 1 and 3|Change in perceived meaningfulness of leisure, Self-report: 1 item. 4-point scale ranging from not at all meaningful (0) to absolutely meaningful (4)., Baseline, 6 months, 1 year, 1.5 years, 2 year for Group 2
Other Outcome Measures: Feasibility, Recruitment, Number of individuals needed to be approached to include desired number of participants at baseline in every age group., Baseline|Feasibility, Number of participants that adhere to each assessment protocol (group), Number of participants that adhere to each assessment protocol (group). For participants' in group 3, number of participants that adhere to the EMA will be registered for each monitoring period., Throughout the 2 year study period|Feasibility, Acceptance of study, Number of individuals that consent to participate in the study., Throughout the 2 year study period|Feasibility, Acceptance of optional parts of study, Number of individuals that consent to participate in any of the optional data collection procedures of the study., Throughout the 2 year study period|Feasibility, Completion rates, Completion rates for the data collection procedures will be assessed. Completion rate means the ratio of the number of participants who complete a data procedure to the total number of participants eligible., Throughout the 2 year study period|Feasibility, Missing data, Amount of missing values in survey responses., Throughout the 2 year study period|National registry data, Health care episodes in inpatient (hospital), Data on health care episodes in inpatient (hospital)., Pre-baseline and continuous over the 2 year study period|National registry data, Outpatient specialist care, Data on outpatient specialist care, including psychiatric care., Pre-baseline and continuous over the 2 year study period|National registry data, Psychiatric conditions, Data on psychiatric conditions., Pre-baseline and continuous over the 2 year study period|National registry data, Pain conditions, Data on pain conditions., Pre-baseline and continuous over the 2 year study period|National registry data, Co-morbidity of psychiatric and pain conditions, Data on co-morbidity of psychiatric and pain conditions., Pre-baseline and continuous over the 2 year study period|National registry data, Psychotropic medication, Use of psychotropic medication., Pre-baseline and continuous over the 2 year study period|National registry data, School absence, Data on school absence., Pre-baseline and continuous over the 2 year study period|Smartphone sensor data, Internet usage, Sensor data on internet usage., Continuous over the 2 year study period|Smartphone sensor data, Reachability, Sensor data on reachability (if connected or not to cellular network, Wi-Fi)., Continuous over the 2 year study period|Smartphone sensor data, General smartphone activity, Sensor data on general smartphone activity (processor use (%)), Continuous over the 2 year study period|Smartphone sensor data, Internet activity, Sensor data include on internet activity (kb/s)., Continuous over the 2 year study period|Smartphone sensor data, Internet availability, Sensor data on internet availability., Continuous over the 2 year study period|Smartphone sensor data, Charger use, Sensor data on charger use., Continuous over the 2 year study period|Smartphone sensor data, Geographical movement patterns, Sensor data geographical movement patterns (measured with location services (GPS) and the accelerometer., Continuous over the 2 year study period|Survey and app metadata, Survey opened, App usage: when a survey was opened., Continuous over the 2 year study period|Survey and app metadata, Time to answer separate measures and questions, App usage: time taken to answer separate measures and questions., Continuous over the 2 year study period|Survey and app metadata, Completion of full survey, App usage: completion of full survey., Continuous over the 2 year study period|Survey and app metadata, Changes made in survey responses, App usage: any changes made in survey responses., Continuous over the 2 year study period