A Study on Young Individuals' Mental Health in Sweden

NCT06490120 | Not Yet Recruiting

• 1 other identifier: UU20230127
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mental Health Issue; Depression, Anxiety; Well-Being, Psychological

Keywords

Mental Health; Trajectories; Multimodal; Young Individuals; Ecological momentary assessment

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (50)

• Change in emotional well-being

  Baseline, 1 year, 2 year for Group 1 and 3

• Change in emotional well-being

  Baseline, 6 months, 1 year, 1.5 years, 2 year for Group 2

• Change in stress

  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

• Change in sleep

  Baseline, 1 year, 2 year for Group 1 and 3

Other Outcomes (24)

• Feasibility, Recruitment

  Baseline

• Feasibility, Number of participants that adhere to each assessment protocol (group)

  Throughout the 2 year study period

• Feasibility, Acceptance of study

  Throughout the 2 year study period

Study Arms (3)

Protocol 1

Mental health is assessed over the course of 2 years, by survey on three occasions: at baseline and follow-ups at 1 and 2 years later.

Other: sampling method

Protocol 2

Mental health is assessed over the course of 2 years, by survey on five occasions: at baseline and 6, 12, 18 and 24 months later.

Other: sampling method

Protocol 3

Mental health is assessed over the course of 2 years, by survey on three occasions: at baseline and follow-ups at 1 and 2 years later. Additionally, a real-time data capture method, ecological momentary assessments (EMA) will be applied directly after baseline and 6, 12 and 18 months later. Participants in group 3 will asked to complete daily registrations using a selection of self-report measures during a one month period. The self-report questions will be distributed via the application with about 5 to 15 questions at a time.

Other: sampling method

Interventions

sampling method OTHER

feasibility outcomes will be compared between the 3 groups

Protocol 1; Protocol 2; Protocol 3

Eligibility Criteria

• Age: 15 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Men and women in the general population in Sweden aged 15-29 years at recruitment

You may qualify if:

• age at recruitment
• ownership of smartphone

You may not qualify if:

• N/A

Sponsors & Collaborators

• Uppsala University: lead
• The Swedish Research Council: collaborator

Study Sites (1)

Uppsala University

Uppsala, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples, analysed for proteomics, metabolomics

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Study Officials

• Pernilla Åsenlöf, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pernilla Asenlof, PhD

CONTACT

+ 46 18 471 47 68; pernilla.asenlof@uu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: July 8, 2024
• Study Start: August 12, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 8, 2024

Record last verified: 2024-06

Locations

SE (1)