NCT04465435

Brief Summary

In 2017, Socialstyrelsen reported that mental ill-health in young adults had increased by almost 70% in the previous10 years. A 2014 report showed that 5% of men and 11% of women 18-24 years were diagnosed with depression or anxiety in Stockholm County. Furthermore, 41% of women 21-24 years have self reported psychological distress. Regarding pain, 28% of men and 36% of women 16-24 years have disabling neck pain. Little is known about the etiology and prognosis of poor mental health in university students. The aim is to advance knowledge about the etiology of depression, anxiety, stress and pain in undergraduate university students. The investigators will study a cohort of students at full-year programs at universities in the Stockholm area. Primary research questions are whether modifiable factors such as sleep quality, lifestyle, screen time and work environment are independent risk factors for incident episodes or unfavorable trajectories of depression, anxiety and pain in men and women? To be able to answer these research questions we designed a prospective cohort study targeting 5000 university students.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,262

participants targeted

Target at P75+ for all trials

Timeline
70mo left

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Aug 2019Jan 2032

Study Start

First participant enrolled

August 19, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
10.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2032

Expected
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

2.3 years

First QC Date

June 17, 2020

Last Update Submit

April 25, 2024

Conditions

Keywords

Cohort studyDepressionAnxietyStressPainLifestyleStudentsRisk FactorsPrognostic factors

Outcome Measures

Primary Outcomes (2)

  • Musculoskeletal pain

    Repeated measures with web-based questionnaires, 5 times (every 3 months), over one year. Outcome measures: Musculoskeletal pain will be measured with the The Nordic Musculoskeletal Questionnaire (NMQ). The NMQ measure musculoskeletal symptoms, and pain intensity in nine body areas: neck, shoulder, elbow, wrists/hands, upper back, lower back, hips/thighs/buttocks, knees, ankle/feet. The questions were modified to assess previous month rather than the previous 12 months as per the original NMQ. No symptoms = a pain score of 0, while the participants who report musculoskeletal symptoms also report average pain intensity over the last month, on a scale from 0 (no complaints), to 9 (pain 'worst possible'). Weekly text messages measure levels of pain.

    2019-2022

  • Mental health problems

    Repeated measures with web-based questionnaires, 5 times (every 3 months), over one year. Outcome measures: Depression Anxiety Stress Scale-21(DASS-21). DASS-21 includes three subscales (range 0-3, score 0-63, higher scores = more symptoms) to measure depression, anxiety and stress symptoms in nonclinical populations. Weekly text messages measure levels anxiety and depression.

    2019-2022

Secondary Outcomes (2)

  • Pain related to the Covid-19 pandemic.

    2019-2020

  • Mental health problems related to the Covid-19 pandemic.

    2019-2020

Study Arms (1)

SUN-participants

University students enrolled in a selected university in Stockholm, studying on a full-time educational program with at least one academic year left before graduation. There is no intervention. The exposures are repeated measures, 5 times (every three months), using web-based self-report questionnaires during one academic year. Also weekley SMS are used to measure depression, anxiety and pain intensity.

Other: Web-based self-report questionnairesOther: Focus Group Interviews

Interventions

Web-based self-report questionnaires based on well established instruments.

SUN-participants

Group conversation with open-ended questions with 7-10 students/group on topics relevant to the aim of the study.

SUN-participants

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAll students invited to participate in the study answer the question about gender identity - female, male or other. All analyses with regard to gender in the study are based on self-representation based on these three categories.
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

University students attending selected universities in Stockholm, Sweden. A number of universities are included representing different educational programs such as medicine and life sciences, business, social sciences and technology. There is a majority of student from medical. and life science educational programs. The aim is to include a total of 5000 students.

You may qualify if:

  • Students at selected universities/colleges in the Stockholm area attending selected educational programs with at least one remaining academic year before graduating. Students from matriculation to master level studies are invited to participate. Participants need to be 18 years of age or older, have access to a smart phone, laptop or tablet and speak sufficient Swedish or English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sophiahemmet University

Stockholm, SE, 11486, Sweden

Location

Related Publications (3)

  • Edlund K, Sundberg T, Johansson F, Onell C, Rudman A, Holm LW, Grotle M, Jensen I, Cote P, Skillgate E. Sustainable UNiversity Life (SUN) study: protocol for a prospective cohort study of modifiable risk and prognostic factors for mental health problems and musculoskeletal pain among university students. BMJ Open. 2022 Apr 4;12(4):e056489. doi: 10.1136/bmjopen-2021-056489.

    PMID: 35379630BACKGROUND
  • Larsson K, Onell C, Edlund K, Kallberg H, Holm LW, Sundberg T, Skillgate E. Lifestyle behaviors in Swedish university students before and during the first six months of the COVID-19 pandemic: a cohort study. BMC Public Health. 2022 Jun 16;22(1):1207. doi: 10.1186/s12889-022-13553-7.

  • Edlund K, Johansson F, Lindroth R, Bergman L, Sundberg T, Skillgate E. Body image and compulsive exercise: are there associations with depression among university students? Eat Weight Disord. 2022 Oct;27(7):2397-2405. doi: 10.1007/s40519-022-01374-x. Epub 2022 Feb 18.

MeSH Terms

Conditions

Musculoskeletal PainDepressionAnxiety DisordersPain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorMental Disorders

Study Officials

  • Eva Skillgate, Professor, Ph.D.

    Sophiahemmet

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 17, 2020

First Posted

July 10, 2020

Study Start

August 19, 2019

Primary Completion

December 15, 2021

Study Completion (Estimated)

January 31, 2032

Last Updated

April 30, 2024

Record last verified: 2024-04

Locations