<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04465435</url>
  </required_header>
  <id_info>
    <org_study_id>FORTE2018-00402</org_study_id>
    <nct_id>NCT04465435</nct_id>
  </id_info>
  <brief_title>Sustainable UNiversity Life (SUN) Study</brief_title>
  <acronym>SUN</acronym>
  <official_title>Sustainable UNiversity Life (SUN): Mental Illness and Pain Conditions Among Students - a Cohort Study to Identify Modifiable Risk and Prognostic Factors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sophiahemmet University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Forte</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sophiahemmet University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In 2017, Socialstyrelsen reported that mental ill-health in young adults had increased by&#xD;
      almost 70% in the previous10 years. A 2014 report showed that 5% of men and 11% of women&#xD;
      18-24 years were diagnosed with depression or anxiety in Stockholm County. Furthermore, 41%&#xD;
      of women 21-24 years have self reported psychological distress. Regarding pain, 28% of men&#xD;
      and 36% of women 16-24 years have disabling neck pain. Little is known about the etiology and&#xD;
      prognosis of poor mental health in university students.&#xD;
&#xD;
      The aim is to advance knowledge about the etiology of depression, anxiety, stress and pain in&#xD;
      undergraduate university students. The investigators will study a cohort of students at&#xD;
      full-year programs at universities in the Stockholm area. Primary research questions are&#xD;
      whether modifiable factors such as sleep quality, lifestyle, screen time and work environment&#xD;
      are independent risk factors for incident episodes or unfavorable trajectories of depression,&#xD;
      anxiety and pain in men and women? To be able to answer these research questions we designed&#xD;
      a prospective cohort study targeting 5000 university students.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study objectives:&#xD;
&#xD;
      The overall study aim is to advance the knowledge about the etiology and prognosis of common&#xD;
      mental health problems (depression, anxiety and stress) and musculoskeletal pain experienced&#xD;
      by undergraduate university students in Sweden.&#xD;
&#xD;
      Specific research questions:&#xD;
&#xD;
      Are modifiable factors as bad sleep quality, meal patterns, low physical activity/sedentary&#xD;
      lifestyle, pain conditions and bad study environment independent risk factors of incident&#xD;
      episodes of troublesome depressive and anxiety symptomatology and musculoskeletal pain and of&#xD;
      unfavorable trajectories of depressive, anxiety, stress and pain symptoms? Are modifiable&#xD;
      factors as bad sleep quality, meal patterns, low physical activity/sedentary lifestyle, pain&#xD;
      conditions and bad study environment independent prognostic factors for recovery from&#xD;
      troublesome depressive and anxiety symptomatology and musculoskeletal pain? Do such potential&#xD;
      risk factors and trajectories vary between men and women? What are the trajectories of sleep&#xD;
      quality, meal patterns, physical activity/sedentary lifestyle, pain and substance use during&#xD;
      one academic year (describe the fluctuations of risk factors)?&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      Cohort study of undergraduate or graduate (up to master level) full time program students, 18&#xD;
      years of age or older, with at least one academic year before graduation, followed-up four&#xD;
      times during an academic year.&#xD;
&#xD;
      Source populations:&#xD;
&#xD;
      The source populations for this project are undergraduate or graduate (up to master level)&#xD;
      full-time program students, 18 years of age or older, with at least one academic year before&#xD;
      graduation at universities in the Stockholm area.&#xD;
&#xD;
      Data collection:&#xD;
&#xD;
      Data collection will be performed with questionnaires through a link sent to students e-mail&#xD;
      address, provided by the participating universities. The students will be able to access the&#xD;
      questionnaire for a four-week period at baseline and each follow-up.&#xD;
&#xD;
      Exposures:&#xD;
&#xD;
      Sleep quality, physical activity and sedentary behavior, substance use in the past three&#xD;
      months (non-medical use), study environment, body image, perfectionism, gambling, compulsive&#xD;
      exercise, social media use, cyberbullying, procrastination and loneliness.&#xD;
&#xD;
      Outcomes:&#xD;
&#xD;
      Outcomes will be measured with the Depression Anxiety Stress Scales-21 (DASS-21). The DASS-21&#xD;
      includes three subscales designed to measure depression, anxiety and stress symptoms in&#xD;
      non-clinical populations with response alternatives on a Likert scale ranging from 0-3.&#xD;
      Higher scores indicate more severe symptoms. Musculoskeletal pain will be measured with the&#xD;
      The Nordic Musculoskeletal pain Questionnaire (NMQ) that cover most potential musculoskeletal&#xD;
      pain sights. The questionnaire measure musculoskeletal symptoms, and pain intensity in nine&#xD;
      body areas: the neck, shoulder, elbow, wrists/hands, upper back, lower back,&#xD;
      hips/thighs/buttocks, knees and ankle/feet. The questions were modified to ask about the&#xD;
      previous month rather than the previous 12 months as per the original NMQ. Those reporting no&#xD;
      symptoms were assigned a pain score of zero, while those who reported having musculoskeletal&#xD;
      symptoms were also asked to report how intense pain was on average over the last month, on a&#xD;
      scale from zero, which refers to no complaints, to nine, which refers to the pain 'as bad as&#xD;
      it can be'.&#xD;
&#xD;
      Potential confounders:&#xD;
&#xD;
      The investigators will collect the following variables as potential confounders of the&#xD;
      association between the exposures and the outcomes. These confounders were selected based on&#xD;
      our review of the literature.&#xD;
&#xD;
      Sociodemographic variables: age, gender, citizenship, marital status, number of dependents,&#xD;
      parents' marital status, parents' employment status, annual personal and household income,&#xD;
      hours of work per week, living arrangement, and commute time.&#xD;
&#xD;
      Academic variables: Overall average in the past year (first year students will provide the&#xD;
      average for the final year of high school), program of study, year of study.&#xD;
&#xD;
      General health and medically diagnosed comorbidities: The investigators will ask participants&#xD;
      to rate their general health and comorbidities diagnosed by a health care provider in the&#xD;
      past year. We will selected comorbidities that are reported by &gt; 5% of the sample in our&#xD;
      pilot study. In the Canadian pilot study, these include: allergies, arthritis, asthma,&#xD;
      attention disorder/learning disability, eating disorder, hypertension, intestinal or stomach&#xD;
      ulcers, migraine headaches, mood disorder, scoliosis, and sexually transmitted infections.&#xD;
&#xD;
      Data analysis and statistics:&#xD;
&#xD;
      Definition of trajectories: Trajectories of the outcomes depression, anxiety, stress symptoms&#xD;
      and pain will emerge by latent class growth mixture models (LCGMM) that allows for the&#xD;
      identification of multiple underlying trajectories within a defined population. In LCGMM,&#xD;
      each trajectory is defined by its own growth parameters (intercept, linear slope), which are&#xD;
      assumed to be latent. We will use the Baysian Information Criteria (BIC), Bootstrap&#xD;
      Likelihood Ratio Test (BLRT) and entropy (measure of uncertainty) to determine whether our&#xD;
      4-trajactory hypothesis offers the best fitting solution for the data. Also trajectories of&#xD;
      sleep quality, food insecurity, physical activity/sedentary lifestyle, and substance use will&#xD;
      be identified with this method.&#xD;
&#xD;
      Associations between exposures and trajectories: The investigators will use multinomial&#xD;
      logistic regression analyses to determine the associations between each of the exposures and&#xD;
      trajectories of outcomes. The investigators will report the associations as odds ratios (OR)&#xD;
      and 95% confidence intervals (95% CI). The investigators will first build bivariate models to&#xD;
      measure the crude associations between the exposures and trajectories. To identify&#xD;
      confounders, the investigators will build models to test whether the inclusion of each&#xD;
      potential confounder produced a ≥ 10% change in any of the associations.&#xD;
&#xD;
      Associations between exposures and incident cases of depression, anxiety, stress symptoms and&#xD;
      pain: At baseline, the investigators will identify a sub-cohort of students at risk of&#xD;
      developing troublesome depressive and anxiety symptoms and pain respectively. The&#xD;
      investigators will use Kaplan-Meier estimates to describe the incidence and discrete time&#xD;
      survival analysis to measure the associations between the exposures and the outcome. In all&#xD;
      models, the reference category will be the level of exposure hypothesized to be associated&#xD;
      with the lowest risk of the outcome. ORs and 95% CIs will be used to describe the strength&#xD;
      and direction of association. The same approach as described above will be used to identify&#xD;
      prognostic factors (starting with a sub-cohort under &quot;risk&quot; of recovery) and for control for&#xD;
      confounding.&#xD;
&#xD;
      Sample size: The investigators estimated the number of parameters that could be included in&#xD;
      the multinomial logistic regression models based on distributions of participants across the&#xD;
      four hypothesized trajectories (no symptoms; improvement; worsening; and persistent) using&#xD;
      two diverse distribution scenarios. In scenario 1, we hypothesized that 70% have no symptoms,&#xD;
      13% experience worsening, 10% improve and 7% have persistent symptoms. In scenario 2, the&#xD;
      investigator hypothesized equal distribution (25%) across trajectories. Based on these&#xD;
      assumptions, the investigators estimated that the models could accommodate between 32&#xD;
      parameters if the investigators recruit 1000 students (scenario 1) to as many as 234&#xD;
      parameters if the investigators recruit 5000 participants (scenario 2).&#xD;
&#xD;
      Covid-19 sub-study:&#xD;
&#xD;
      The recruitment and data collection for the cohort study took place before and during the&#xD;
      Covid-19 pandemic.Therefore, the investigators started a more fequent recording of levels of&#xD;
      pain, axiety and depression from May 2020 with weekly text messages. The data Collection&#xD;
      before and during the pandemic provide a chance to investigate the change in symptoms of&#xD;
      depression, anxiety and stress and lifestyle behaviors in relation to the pandemic. The&#xD;
      specific research questions with regards to this Covid-19-related sub-study are: 1) Are there&#xD;
      any changes regarding symptoms of mental health problems during the first month of the&#xD;
      pandemic? 2) Will students display changes in healthy lifestyle behaviors such as sleep&#xD;
      patterns and quality, meal pattern, exercise and substance use during the first month of the&#xD;
      pandemic and 3) Different trajectories of symptoms of low mood, worry and pain during the&#xD;
      course of the pandemic will be measured weekly with the aim of identifying factors related to&#xD;
      unfavorable trajectories.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 19, 2019</start_date>
  <completion_date type="Anticipated">January 31, 2032</completion_date>
  <primary_completion_date type="Actual">December 15, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Musculoskeletal pain</measure>
    <time_frame>2019-2022</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mental health problems</measure>
    <time_frame>2019-2022</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain related to the Covid-19 pandemic.</measure>
    <time_frame>2019-2020</time_frame>
    <description>Web-based questionnaires comparing students entering the study before the Covid-19 pandemic and after. 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental health problems related to the Covid-19 pandemic.</measure>
    <time_frame>2019-2020</time_frame>
    <description>Web-based questionnaires comparing students entering the study before the Covid-19 pandemic and after. Outcome measures: Depression Anxiety Stress Scale-21(DASS-21). DASS-21 (3 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 of anxiety and depression.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">4262</enrollment>
  <condition>Mental Health Issue</condition>
  <condition>Musculoskeletal Pain</condition>
  <arm_group>
    <arm_group_label>SUN-participants</arm_group_label>
    <description>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.&#xD;
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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Web-based self-report questionnaires</intervention_name>
    <description>Web-based self-report questionnaires based on well established instruments.</description>
    <arm_group_label>SUN-participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Focus Group Interviews</intervention_name>
    <description>Group conversation with open-ended questions with 7-10 students/group on topics relevant to the aim of the study.</description>
    <arm_group_label>SUN-participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        University students attending selected universities in Stockholm, Sweden. A number of&#xD;
        universities are included representing different educational programs such as medicine and&#xD;
        life sciences, business, social sciences and technology. There is a majority of student&#xD;
        from medical. and life science educational programs. The aim is to include a total of 5000&#xD;
        students.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Students at selected universities/colleges in the Stockholm area attending selected&#xD;
        educational programs with at least one remaining academic year before graduating. Students&#xD;
        from matriculation to master level studies are invited to participate. Participants need to&#xD;
        be 18 years of age or older, have access to a smart phone, laptop or tablet and speak&#xD;
        sufficient Swedish or English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>All 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.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Eva Skillgate, Professor, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sophiahemmet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sophiahemmet University</name>
      <address>
        <city>Stockholm</city>
        <state>SE</state>
        <zip>11486</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>November 17, 2022</last_update_submitted>
  <last_update_submitted_qc>November 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cohort study</keyword>
  <keyword>Depression</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Stress</keyword>
  <keyword>Pain</keyword>
  <keyword>Lifestyle</keyword>
  <keyword>Students</keyword>
  <keyword>Risk Factors</keyword>
  <keyword>Prognostic factors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Parallell studies in Norway and Canada have been planned for cross-cultural comparisons with merged data sets.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04465435
org study id: FORTE2018-00402
nct id: NCT04465435
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
Study objectives:

      The overall study aim is to advance the knowledge about the etiology and prognosis of common
      mental health problems (depression, anxiety and stress) and musculoskeletal pain experienced
      by undergraduate university students in Sweden.

      Specific research questions:

      Are modifiable factors as bad sleep quality, meal patterns, low physical activity/sedentary
      lifestyle, pain conditions and bad study environment independent risk factors of incident
      episodes of troublesome depressive and anxiety symptomatology and musculoskeletal pain and of
      unfavorable trajectories of depressive, anxiety, stress and pain symptoms? Are modifiable
      factors as bad sleep quality, meal patterns, low physical activity/sedentary lifestyle, pain
      conditions and bad study environment independent prognostic factors for recovery from
      troublesome depressive and anxiety symptomatology and musculoskeletal pain? Do such potential
      risk factors and trajectories vary between men and women? What are the trajectories of sleep
      quality, meal patterns, physical activity/sedentary lifestyle, pain and substance use during
      one academic year (describe the fluctuations of risk factors)?

      Study design:

      Cohort study of undergraduate or graduate (up to master level) full time program students, 18
      years of age or older, with at least one academic year before graduation, followed-up four
      times during an academic year.

      Source populations:

      The source populations for this project are undergraduate or graduate (up to master level)
      full-time program students, 18 years of age or older, with at least one academic year before
      graduation at universities in the Stockholm area.

      Data collection:

      Data collection will be performed with questionnaires through a link sent to students e-mail
      address, provided by the participating universities. The students will be able to access the
      questionnaire for a four-week period at baseline and each follow-up.

      Exposures:

      Sleep quality, physical activity and sedentary behavior, substance use in the past three
      months (non-medical use), study environment, body image, perfectionism, gambling, compulsive
      exercise, social media use, cyberbullying, procrastination and loneliness.

      Outcomes:

      Outcomes will be measured with the Depression Anxiety Stress Scales-21 (DASS-21). The DASS-21
      includes three subscales designed to measure depression, anxiety and stress symptoms in
      non-clinical populations with response alternatives on a Likert scale ranging from 0-3.
      Higher scores indicate more severe symptoms. Musculoskeletal pain will be measured with the
      The Nordic Musculoskeletal pain Questionnaire (NMQ) that cover most potential musculoskeletal
      pain sights. The questionnaire measure musculoskeletal symptoms, and pain intensity in nine
      body areas: the neck, shoulder, elbow, wrists/hands, upper back, lower back,
      hips/thighs/buttocks, knees and ankle/feet. The questions were modified to ask about the
      previous month rather than the previous 12 months as per the original NMQ. Those reporting no
      symptoms were assigned a pain score of zero, while those who reported having musculoskeletal
      symptoms were also asked to report how intense pain was on average over the last month, on a
      scale from zero, which refers to no complaints, to nine, which refers to the pain 'as bad as
      it can be'.

      Potential confounders:

      The investigators will collect the following variables as potential confounders of the
      association between the exposures and the outcomes. These confounders were selected based on
      our review of the literature.

      Sociodemographic variables: age, gender, citizenship, marital status, number of dependents,
      parents' marital status, parents' employment status, annual personal and household income,
      hours of work per week, living arrangement, and commute time.

      Academic variables: Overall average in the past year (first year students will provide the
      average for the final year of high school), program of study, year of study.

      General health and medically diagnosed comorbidities: The investigators will ask participants
      to rate their general health and comorbidities diagnosed by a health care provider in the
      past year. We will selected comorbidities that are reported by > 5% of the sample in our
      pilot study. In the Canadian pilot study, these include: allergies, arthritis, asthma,
      attention disorder/learning disability, eating disorder, hypertension, intestinal or stomach
      ulcers, migraine headaches, mood disorder, scoliosis, and sexually transmitted infections.

      Data analysis and statistics:

      Definition of trajectories: Trajectories of the outcomes depression, anxiety, stress symptoms
      and pain will emerge by latent class growth mixture models (LCGMM) that allows for the
      identification of multiple underlying trajectories within a defined population. In LCGMM,
      each trajectory is defined by its own growth parameters (intercept, linear slope), which are
      assumed to be latent. We will use the Baysian Information Criteria (BIC), Bootstrap
      Likelihood Ratio Test (BLRT) and entropy (measure of uncertainty) to determine whether our
      4-trajactory hypothesis offers the best fitting solution for the data. Also trajectories of
      sleep quality, food insecurity, physical activity/sedentary lifestyle, and substance use will
      be identified with this method.

      Associations between exposures and trajectories: The investigators will use multinomial
      logistic regression analyses to determine the associations between each of the exposures and
      trajectories of outcomes. The investigators will report the associations as odds ratios (OR)
      and 95% confidence intervals (95% CI). The investigators will first build bivariate models to
      measure the crude associations between the exposures and trajectories. To identify
      confounders, the investigators will build models to test whether the inclusion of each
      potential confounder produced a ≥ 10% change in any of the associations.

      Associations between exposures and incident cases of depression, anxiety, stress symptoms and
      pain: At baseline, the investigators will identify a sub-cohort of students at risk of
      developing troublesome depressive and anxiety symptoms and pain respectively. The
      investigators will use Kaplan-Meier estimates to describe the incidence and discrete time
      survival analysis to measure the associations between the exposures and the outcome. In all
      models, the reference category will be the level of exposure hypothesized to be associated
      with the lowest risk of the outcome. ORs and 95% CIs will be used to describe the strength
      and direction of association. The same approach as described above will be used to identify
      prognostic factors (starting with a sub-cohort under "risk" of recovery) and for control for
      confounding.

      Sample size: The investigators estimated the number of parameters that could be included in
      the multinomial logistic regression models based on distributions of participants across the
      four hypothesized trajectories (no symptoms; improvement; worsening; and persistent) using
      two diverse distribution scenarios. In scenario 1, we hypothesized that 70% have no symptoms,
      13% experience worsening, 10% improve and 7% have persistent symptoms. In scenario 2, the
      investigator hypothesized equal distribution (25%) across trajectories. Based on these
      assumptions, the investigators estimated that the models could accommodate between 32
      parameters if the investigators recruit 1000 students (scenario 1) to as many as 234
      parameters if the investigators recruit 5000 participants (scenario 2).

      Covid-19 sub-study:

      The recruitment and data collection for the cohort study took place before and during the
      Covid-19 pandemic.Therefore, the investigators started a more fequent recording of levels of
      pain, axiety and depression from May 2020 with weekly text messages. The data Collection
      before and during the pandemic provide a chance to investigate the change in symptoms of
      depression, anxiety and stress and lifestyle behaviors in relation to the pandemic. The
      specific research questions with regards to this Covid-19-related sub-study are: 1) Are there
      any changes regarding symptoms of mental health problems during the first month of the
      pandemic? 2) Will students display changes in healthy lifestyle behaviors such as sleep
      patterns and quality, meal pattern, exercise and substance use during the first month of the
      pandemic and 3) Different trajectories of symptoms of low mood, worry and pain during the
      course of the pandemic will be measured weekly with the aim of identifying factors related to
      unfavorable trajectories.
observational model: Cohort
time perspective: Prospective
measure: Musculoskeletal pain
time frame: 2019-2022
description: 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.
measure: Mental health problems
time frame: 2019-2022
description: 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.
measure: Pain related to the Covid-19 pandemic.
time frame: 2019-2020
description: Web-based questionnaires comparing students entering the study before the Covid-19 pandemic and after. 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.
measure: Mental health problems related to the Covid-19 pandemic.
time frame: 2019-2020
description: Web-based questionnaires comparing students entering the study before the Covid-19 pandemic and after. Outcome measures: Depression Anxiety Stress Scale-21(DASS-21). DASS-21 (3 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 of anxiety and depression.
arm group label: SUN-participants
description: 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.
intervention type: Other
intervention name: Web-based self-report questionnaires
description: Web-based self-report questionnaires based on well established instruments.
arm group label: SUN-participants
intervention type: Other
intervention name: Focus Group Interviews
description: Group conversation with open-ended questions with 7-10 students/group on topics relevant to the aim of the study.
arm group label: SUN-participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: All 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.
minimum age: 18 Years
maximum age: N/A
last name: Eva Skillgate, Professor, Ph.D.
role: Principal Investigator
affiliation: Sophiahemmet
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Musculoskeletal Pain
sharing ipd: Undecided
ipd description: Parallell studies in Norway and Canada have been planned for cross-cultural comparisons with merged data sets.