xml: <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/NCT05989412</url>
    </required_header>
    <id_info>
      <org_study_id>NL84280.078.23</org_study_id>
      <nct_id>NCT05989412</nct_id>
    </id_info>
    <brief_title>Mobile Screening for Major Depressive Disorder in Adults From an Ethnically and Socioeconomically Diverse Population.</brief_title>
    <acronym>MOOD</acronym>
    <official_title>Mobile Screening for Major Depressive Disorder in Adults From an Ethnically and Socioeconomically Diverse Population.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Erasmus Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Erasmus Medical Center</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>
        Major depressive disorder (MDD) is a mental disorder leading to a variety of emotional and&#xD;
        physical problems affecting almost 300 million people worldwide. Long-term treatments for&#xD;
        MDD, including medication and therapy, imposes a significant financial burden on society.&#xD;
        Mobile-based screening interventions might be a promising approach for effectively reducing&#xD;
        MDD symptoms. The investigators hypothesize that the mobile-based screening strategy&#xD;
        evaluated in this proposal will substantially reduce the burden of MDD over time, increase&#xD;
        participants' quality of life, and decrease MDD-related disparities&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The MOOD trial is designed as a prospective, randomized controlled multi-arm trial with three&#xD;
        parallel groups: an intervention group that will be screened 4-weekly for MDD for 12 months&#xD;
        and receives a referral for MDD diagnosis and treatment after one positive test score on the&#xD;
        PHQ-9, an intervention group who will be screened the same as the first group but receives a&#xD;
        referral for MDD diagnosis and treatment after three consecutive positive test scores on the&#xD;
        PHQ-9 and a control group who do not receive mobile-based screening for MDD. Randomization&#xD;
        will be performed by the Your Research application as block randomization with a 1:1:1.5&#xD;
        allocation. The sample size is calculated to be 450 participants in each intervention group&#xD;
        and 675 participants in the control group, considering the 5% loss of observations. Dropouts&#xD;
        due to adverse events are included in the sample size calculations. The intervention will be&#xD;
        powered to demonstrate an effect on the quality of life with 80% power at a 5% significance&#xD;
        threshold. It assumes that averted MDD will results in a 0.40 improvement in quality of life&#xD;
        (per observational data) and that frequent screening will be effective in 40% of participants&#xD;
        with MDD (based on preliminary simulations).&#xD;
  &#xD;
        Participants will follow the individual screening procedure through the application platform&#xD;
        Your Research. Participants will be invited to create a secured personal account, after which&#xD;
        they can log in through a website on their computer/laptop or by installing the Your Research&#xD;
        app on their tablet or mobile phone. There will be a variety of platforms provided for&#xD;
        additional inquiries about the study process, including video calls, chat options, and phone&#xD;
        calls.&#xD;
  &#xD;
        Participants will be recruited through different online and offline strategies to encourage&#xD;
        citizens' participation according to different cultural backgrounds. Offline recruitment&#xD;
        includes in-person interactions with community members referred to be &quot;key figures&quot;, posting&#xD;
        flyers in GP offices and municipal buildings, video promotion, presentations, and by&#xD;
        addressing people personally in public areas. Online recruitment postings will be made on&#xD;
        websites, social media networks, and local radio stations.&#xD;
  &#xD;
        Interested individuals can enroll by visiting the study website, or by initiating an&#xD;
        application procedure through the Your Research app. If preferred, contacting the&#xD;
        investigators through phone or email is also possible. Eligible participants will&#xD;
        subsequently be provided with the patient information form (PIF) as well as an informed&#xD;
        consent form. Participants who complete and return the signed consent form will be enrolled&#xD;
        and randomized in the trial. The informed consent procedure is conducted digitally by using&#xD;
        ValidSign. After randomization, participants will complete the baseline assessment.&#xD;
  &#xD;
        Recruitment will be closely monitored to ensure that the sample size will be reached. If the&#xD;
        sample size is attained, inclusion tactics will be discontinued. Furthermore, to ensure that&#xD;
        questionnaire assessments are completed and that participants remain in the study,&#xD;
        researchers will automatically send reminders via several contact channels based on the&#xD;
        participants' preferences (email, push notifications, SMS). Participants will be compensated&#xD;
        for their participation at the end of the study. Depending on the study arm and the number of&#xD;
        completed questionnaires the participants can earn up to €50 in gift cards. Participants have&#xD;
        the option to withdraw from the study at any moment during the trial. Recruitment will take&#xD;
        place between November 2023 and April 2024.&#xD;
  &#xD;
        Primary and secondary outcome measures for the MOOD study will be collected using&#xD;
        mobile-based questionnaires. Data can be collected throughout the study and stored using&#xD;
        encrypted digital files within password-protected folders with access limited to a restricted&#xD;
        number of researchers. To protect confidentiality, participants will be granted a unique&#xD;
        participant identification number upon registration. This number, as well as the associated&#xD;
        personal information, is only available to the lead investigator and team members under their&#xD;
        supervision. Contact information will be kept separate from any other research data gathered&#xD;
        throughout the study. After the study is finished, all data will be safely archived for 15&#xD;
        years within Erasmus Medical Center. Once all outcome data has been collected, it will be&#xD;
        exported to a statistics program. Members of the research team will examine and clean the&#xD;
        data. All data will be kept and stored in accordance with the Personal Data Protection Act.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">September 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>The investigators will randomize 1575 eligible respondents across three arms, in a 1.5:1:1 fashion. The three arms comprise a control arm, a screening arm with limited participant referral for treatment (after three positive test scores on Patient Health questionnaire-9 (PHQ-9) or suicidal ideation), and a screening arm with standard referral for participants with moderate-severe symptoms of major depression (single positive test score on PHQ-9 questionnaire).</intervention_model_description>
      <primary_purpose>Screening</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Quality of life scores over time</measure>
      <time_frame>24 months</time_frame>
      <description>Primary outcomes of the trial include participants' quality of life after 24 months as measured by the EQ-5D-5L. EQ-5D-5L will also be assessed at baseline, and again at 6 and 12 months.&#xD;
  The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. A higher digit number means a worse outcome. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Major depressive disorder symptoms</measure>
      <time_frame>12 months</time_frame>
      <description>The investigators will also examine the occurrence and severity of symptoms as measured by the PHQ-9. If participants are not referred to their GP due to one or three consecutive positive test scores on PHQ-9 during the course of the 12-month intervention period, PHQ-9 will be evaluated every four weeks for both intervention groups.&#xD;
  The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression including 9 questions and a 4-scale-based answer option (Not at all, Several days, More than half the days, Nearly every day). Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe, and severe depression, respectively. Scores on the PHQ-9 range from 0 to 27. A higher score means a worse outcome</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Screening adherence</measure>
      <time_frame>12 months</time_frame>
      <description>Measurements of participation</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">1575</enrollment>
    <condition>Major Depressive Disorder</condition>
    <arm_group>
      <arm_group_label>Control arm</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>a control arm where the investigators will only measure the quality of life using the EQ-5D questionnaire. This measurement will be performed at the same time as both screening arms.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard referral</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>a screening arm with standard participant referral for diagnosis at the general practitioner's office (after 1 positive test score on the PHQ-9 questionnaire or suicidal ideation).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Limited referral</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>a screening arm with limited participant referral for diagnosis at the general practitioner's office (after three consecutive positive test scores on the PHQ-9 questionnaire or suicidal ideation).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Patient health questionnaire-9 via the Your Research application</intervention_name>
      <description>Both intervention arms will have 4-weekly screening with either lenient follow-up or screening with stricter follow-up for a time period of one year. Data will be collected via an app designed by Your Research which runs on Microsoft Azure server, as the primary of participants' response collection. A dedicated backup system will serve as a secondary data collection.</description>
      <arm_group_label>Limited referral</arm_group_label>
      <arm_group_label>Standard referral</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  At least 18 years old Live in Rotterdam Zuid&#xD;
  &#xD;
            -  Have a smartphone&#xD;
  &#xD;
            -  Give informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - Is currently treated by a psychologist or psychiatrist&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Inge de Kok, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Erasmus Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Michelle Zandbergen, Msc</last_name>
      <phone>+31621509410</phone>
      <email>m.zandbergen@erasmusmc.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Erik Jansen, Msc</last_name>
      <phone>+31 6 48931356</phone>
      <email>e.e.l.jansen@erasmusmc.nl</email>
    </overall_contact_backup>
    <reference>
      <citation>Abdoli N, Salari N, Darvishi N, Jafarpour S, Solaymani M, Mohammadi M, Shohaimi S. The global prevalence of major depressive disorder (MDD) among the elderly: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2022 Jan;132:1067-1073. doi: 10.1016/j.neubiorev.2021.10.041. Epub 2021 Nov 4.</citation>
      <PMID>34742925</PMID>
    </reference>
    <reference>
      <citation>Almeida OP. Prevention of depression in older age. Maturitas. 2014 Oct;79(2):136-41. doi: 10.1016/j.maturitas.2014.03.005. Epub 2014 Mar 22.</citation>
      <PMID>24713453</PMID>
    </reference>
    <reference>
      <citation>Gotlib IH, Goodman SH, Humphreys KL. Studying the Intergenerational Transmission of Risk for Depression: Current Status and Future Directions. Curr Dir Psychol Sci. 2020 Apr 1;29(2):174-179. doi: 10.1177/0963721420901590. Epub 2020 Feb 24.</citation>
      <PMID>33758474</PMID>
    </reference>
    <reference>
      <citation>Hall CA, Reynolds-Iii CF. Late-life depression in the primary care setting: challenges, collaborative care, and prevention. Maturitas. 2014 Oct;79(2):147-52. doi: 10.1016/j.maturitas.2014.05.026. Epub 2014 Jun 7.</citation>
      <PMID>24996484</PMID>
    </reference>
    <reference>
      <citation>GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8. Erratum In: Lancet. 2019 Jun 22;393(10190):e44.</citation>
      <PMID>30496104</PMID>
    </reference>
    <reference>
      <citation>Kalibatseva Z, Leong FT. Depression among Asian Americans: Review and Recommendations. Depress Res Treat. 2011;2011:320902. doi: 10.1155/2011/320902. Epub 2011 Sep 27.</citation>
      <PMID>21961060</PMID>
    </reference>
    <reference>
      <citation>Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.</citation>
      <PMID>11556941</PMID>
    </reference>
    <reference>
      <citation>Liu Q, He H, Yang J, Feng X, Zhao F, Lyu J. Changes in the global burden of depression from 1990 to 2017: Findings from the Global Burden of Disease study. J Psychiatr Res. 2020 Jul;126:134-140. doi: 10.1016/j.jpsychires.2019.08.002. Epub 2019 Aug 10.</citation>
      <PMID>31439359</PMID>
    </reference>
    <reference>
      <citation>O'Connor EA, Whitlock EP, Beil TL, Gaynes BN. Screening for depression in adult patients in primary care settings: a systematic evidence review. Ann Intern Med. 2009 Dec 1;151(11):793-803. doi: 10.7326/0003-4819-151-11-200912010-00007.</citation>
      <PMID>19949145</PMID>
    </reference>
    <reference>
      <citation>Park LT, Zarate CA Jr. Depression in the Primary Care Setting. N Engl J Med. 2019 Feb 7;380(6):559-568. doi: 10.1056/NEJMcp1712493.</citation>
      <PMID>30726688</PMID>
    </reference>
    <reference>
      <citation>Posternak MA, Miller I. Untreated short-term course of major depression: a meta-analysis of outcomes from studies using wait-list control groups. J Affect Disord. 2001 Oct;66(2-3):139-46. doi: 10.1016/s0165-0327(00)00304-9.</citation>
      <PMID>11578666</PMID>
    </reference>
    <reference>
      <citation>Rohde P, Lewinsohn PM, Klein DN, Seeley JR, Gau JM. Key Characteristics of Major Depressive Disorder Occurring in Childhood, Adolescence, Emerging Adulthood, Adulthood. Clin Psychol Sci. 2013 Jan;1(1):10.1177/2167702612457599. doi: 10.1177/2167702612457599.</citation>
      <PMID>24273703</PMID>
    </reference>
    <reference>
      <citation>Siu AL; US Preventive Services Task Force (USPSTF); Bibbins-Domingo K, Grossman DC, Baumann LC, Davidson KW, Ebell M, Garcia FA, Gillman M, Herzstein J, Kemper AR, Krist AH, Kurth AE, Owens DK, Phillips WR, Phipps MG, Pignone MP. Screening for Depression in Adults: US Preventive Services Task Force Recommendation Statement. JAMA. 2016 Jan 26;315(4):380-7. doi: 10.1001/jama.2015.18392.</citation>
      <PMID>26813211</PMID>
    </reference>
    <reference>
      <citation>Sobocki P, Jonsson B, Angst J, Rehnberg C. Cost of depression in Europe. J Ment Health Policy Econ. 2006 Jun;9(2):87-98.</citation>
      <PMID>17007486</PMID>
    </reference>
    <reference>
      <citation>Steensma C, Loukine L, Orpana H, McRae L, Vachon J, Mo F, Boileau-Falardeau M, Reid C, Choi BC. Describing the population health burden of depression: health-adjusted life expectancy by depression status in Canada. Health Promot Chronic Dis Prev Can. 2016 Oct;36(10):205-213. doi: 10.24095/hpcdp.36.10.01.</citation>
      <PMID>27768557</PMID>
    </reference>
    <reference>
      <citation>Whiteford HA, Harris MG, McKeon G, Baxter A, Pennell C, Barendregt JJ, Wang J. Estimating remission from untreated major depression: a systematic review and meta-analysis. Psychol Med. 2013 Aug;43(8):1569-85. doi: 10.1017/S0033291712001717. Epub 2012 Aug 10.</citation>
      <PMID>22883473</PMID>
    </reference>
    <reference>
      <citation>Yildiz B, Schuring M, Knoef MG, Burdorf A. Chronic diseases and multimorbidity among unemployed and employed persons in the Netherlands: a register-based cross-sectional study. BMJ Open. 2020 Jul 2;10(7):e035037. doi: 10.1136/bmjopen-2019-035037.</citation>
      <PMID>32616488</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
      <investigator_full_name>Inge MCM de Kok</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Randomized controlled trial</keyword>
    <keyword>Major depressive disorder</keyword>
    <keyword>Screening intervention</keyword>
    <keyword>eHealth</keyword>
    <keyword>Mental health</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depressive Disorder</mesh_term>
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder, Major</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data of participants that did not grant permission to reuse their data for future research will have to be removed. Furthermore, further pseudonymisation and/or aggregation of the pseudonymised dataset would be required to secure the privacy of the participants and avoid indirect identification.&#xD;
  The accessibility of the collected data could be important for potential follow-up research of this project and/or similar national/international projects that would like to perform analyses on our data because not much is known yet on the implementation of screening for MDD.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>The data will be published within 10 months and will be available from then on.</ipd_time_frame>
      <ipd_access_criteria>Open source publication</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05989412
  org study id: NL84280.078.23
  nct id: NCT05989412
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Major depressive disorder (MDD) is a mental disorder leading to a variety of emotional and
        physical problems affecting almost 300 million people worldwide. Long-term treatments for
        MDD, including medication and therapy, imposes a significant financial burden on society.
        Mobile-based screening interventions might be a promising approach for effectively reducing
        MDD symptoms. The investigators hypothesize that the mobile-based screening strategy
        evaluated in this proposal will substantially reduce the burden of MDD over time, increase
        participants' quality of life, and decrease MDD-related disparities
  The MOOD trial is designed as a prospective, randomized controlled multi-arm trial with three
        parallel groups: an intervention group that will be screened 4-weekly for MDD for 12 months
        and receives a referral for MDD diagnosis and treatment after one positive test score on the
        PHQ-9, an intervention group who will be screened the same as the first group but receives a
        referral for MDD diagnosis and treatment after three consecutive positive test scores on the
        PHQ-9 and a control group who do not receive mobile-based screening for MDD. Randomization
        will be performed by the Your Research application as block randomization with a 1:1:1.5
        allocation. The sample size is calculated to be 450 participants in each intervention group
        and 675 participants in the control group, considering the 5% loss of observations. Dropouts
        due to adverse events are included in the sample size calculations. The intervention will be
        powered to demonstrate an effect on the quality of life with 80% power at a 5% significance
        threshold. It assumes that averted MDD will results in a 0.40 improvement in quality of life
        (per observational data) and that frequent screening will be effective in 40% of participants
        with MDD (based on preliminary simulations).
  
        Participants will follow the individual screening procedure through the application platform
        Your Research. Participants will be invited to create a secured personal account, after which
        they can log in through a website on their computer/laptop or by installing the Your Research
        app on their tablet or mobile phone. There will be a variety of platforms provided for
        additional inquiries about the study process, including video calls, chat options, and phone
        calls.
  
        Participants will be recruited through different online and offline strategies to encourage
        citizens' participation according to different cultural backgrounds. Offline recruitment
        includes in-person interactions with community members referred to be "key figures", posting
        flyers in GP offices and municipal buildings, video promotion, presentations, and by
        addressing people personally in public areas. Online recruitment postings will be made on
        websites, social media networks, and local radio stations.
  
        Interested individuals can enroll by visiting the study website, or by initiating an
        application procedure through the Your Research app. If preferred, contacting the
        investigators through phone or email is also possible. Eligible participants will
        subsequently be provided with the patient information form (PIF) as well as an informed
        consent form. Participants who complete and return the signed consent form will be enrolled
        and randomized in the trial. The informed consent procedure is conducted digitally by using
        ValidSign. After randomization, participants will complete the baseline assessment.
  
        Recruitment will be closely monitored to ensure that the sample size will be reached. If the
        sample size is attained, inclusion tactics will be discontinued. Furthermore, to ensure that
        questionnaire assessments are completed and that participants remain in the study,
        researchers will automatically send reminders via several contact channels based on the
        participants' preferences (email, push notifications, SMS). Participants will be compensated
        for their participation at the end of the study. Depending on the study arm and the number of
        completed questionnaires the participants can earn up to €50 in gift cards. Participants have
        the option to withdraw from the study at any moment during the trial. Recruitment will take
        place between November 2023 and April 2024.
  
        Primary and secondary outcome measures for the MOOD study will be collected using
        mobile-based questionnaires. Data can be collected throughout the study and stored using
        encrypted digital files within password-protected folders with access limited to a restricted
        number of researchers. To protect confidentiality, participants will be granted a unique
        participant identification number upon registration. This number, as well as the associated
        personal information, is only available to the lead investigator and team members under their
        supervision. Contact information will be kept separate from any other research data gathered
        throughout the study. After the study is finished, all data will be safely archived for 15
        years within Erasmus Medical Center. Once all outcome data has been collected, it will be
        exported to a statistics program. Members of the research team will examine and clean the
        data. All data will be kept and stored in accordance with the Personal Data Protection Act.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The investigators will randomize 1575 eligible respondents across three arms, in a 1.5:1:1 fashion. The three arms comprise a control arm, a screening arm with limited participant referral for treatment (after three positive test scores on Patient Health questionnaire-9 (PHQ-9) or suicidal ideation), and a screening arm with standard referral for participants with moderate-severe symptoms of major depression (single positive test score on PHQ-9 questionnaire).
  primary purpose: Screening
  masking: None (Open Label)
  measure: Quality of life scores over time
  time frame: 24 months
  description: Primary outcomes of the trial include participants' quality of life after 24 months as measured by the EQ-5D-5L. EQ-5D-5L will also be assessed at baseline, and again at 6 and 12 months.
  The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. A higher digit number means a worse outcome. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
  measure: Major depressive disorder symptoms
  time frame: 12 months
  description: The investigators will also examine the occurrence and severity of symptoms as measured by the PHQ-9. If participants are not referred to their GP due to one or three consecutive positive test scores on PHQ-9 during the course of the 12-month intervention period, PHQ-9 will be evaluated every four weeks for both intervention groups.
  The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression including 9 questions and a 4-scale-based answer option (Not at all, Several days, More than half the days, Nearly every day). Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe, and severe depression, respectively. Scores on the PHQ-9 range from 0 to 27. A higher score means a worse outcome
  measure: Screening adherence
  time frame: 12 months
  description: Measurements of participation
  arm group label: Control arm
  arm group type: No Intervention
  description: a control arm where the investigators will only measure the quality of life using the EQ-5D questionnaire. This measurement will be performed at the same time as both screening arms.
  arm group label: Standard referral
  arm group type: Experimental
  description: a screening arm with standard participant referral for diagnosis at the general practitioner's office (after 1 positive test score on the PHQ-9 questionnaire or suicidal ideation).
  arm group label: Limited referral
  arm group type: Experimental
  description: a screening arm with limited participant referral for diagnosis at the general practitioner's office (after three consecutive positive test scores on the PHQ-9 questionnaire or suicidal ideation).
  intervention type: Other
  intervention name: Patient health questionnaire-9 via the Your Research application
  description: Both intervention arms will have 4-weekly screening with either lenient follow-up or screening with stricter follow-up for a time period of one year. Data will be collected via an app designed by Your Research which runs on Microsoft Azure server, as the primary of participants' response collection. A dedicated backup system will serve as a secondary data collection.
  arm group label: Limited referral
  arm group label: Standard referral
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Inge de Kok, PhD
  role: Principal Investigator
  affiliation: Erasmus Medical Center
  last name: Michelle Zandbergen, Msc
  phone: +31621509410
  email: m.zandbergen@erasmusmc.nl
  last name: Erik Jansen, Msc
  phone: +31 6 48931356
  email: e.e.l.jansen@erasmusmc.nl
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  PMID: 34742925
  citation: Almeida OP. Prevention of depression in older age. Maturitas. 2014 Oct;79(2):136-41. doi: 10.1016/j.maturitas.2014.03.005. Epub 2014 Mar 22.
  PMID: 24713453
  citation: Gotlib IH, Goodman SH, Humphreys KL. Studying the Intergenerational Transmission of Risk for Depression: Current Status and Future Directions. Curr Dir Psychol Sci. 2020 Apr 1;29(2):174-179. doi: 10.1177/0963721420901590. Epub 2020 Feb 24.
  PMID: 33758474
  citation: Hall CA, Reynolds-Iii CF. Late-life depression in the primary care setting: challenges, collaborative care, and prevention. Maturitas. 2014 Oct;79(2):147-52. doi: 10.1016/j.maturitas.2014.05.026. Epub 2014 Jun 7.
  PMID: 24996484
  citation: GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8. Erratum In: Lancet. 2019 Jun 22;393(10190):e44.
  PMID: 30496104
  citation: Kalibatseva Z, Leong FT. Depression among Asian Americans: Review and Recommendations. Depress Res Treat. 2011;2011:320902. doi: 10.1155/2011/320902. Epub 2011 Sep 27.
  PMID: 21961060
  citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
  PMID: 11556941
  citation: Liu Q, He H, Yang J, Feng X, Zhao F, Lyu J. Changes in the global burden of depression from 1990 to 2017: Findings from the Global Burden of Disease study. J Psychiatr Res. 2020 Jul;126:134-140. doi: 10.1016/j.jpsychires.2019.08.002. Epub 2019 Aug 10.
  PMID: 31439359
  citation: O'Connor EA, Whitlock EP, Beil TL, Gaynes BN. Screening for depression in adult patients in primary care settings: a systematic evidence review. Ann Intern Med. 2009 Dec 1;151(11):793-803. doi: 10.7326/0003-4819-151-11-200912010-00007.
  PMID: 19949145
  citation: Park LT, Zarate CA Jr. Depression in the Primary Care Setting. N Engl J Med. 2019 Feb 7;380(6):559-568. doi: 10.1056/NEJMcp1712493.
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  citation: Posternak MA, Miller I. Untreated short-term course of major depression: a meta-analysis of outcomes from studies using wait-list control groups. J Affect Disord. 2001 Oct;66(2-3):139-46. doi: 10.1016/s0165-0327(00)00304-9.
  PMID: 11578666
  citation: Rohde P, Lewinsohn PM, Klein DN, Seeley JR, Gau JM. Key Characteristics of Major Depressive Disorder Occurring in Childhood, Adolescence, Emerging Adulthood, Adulthood. Clin Psychol Sci. 2013 Jan;1(1):10.1177/2167702612457599. doi: 10.1177/2167702612457599.
  PMID: 24273703
  citation: Siu AL; US Preventive Services Task Force (USPSTF); Bibbins-Domingo K, Grossman DC, Baumann LC, Davidson KW, Ebell M, Garcia FA, Gillman M, Herzstein J, Kemper AR, Krist AH, Kurth AE, Owens DK, Phillips WR, Phipps MG, Pignone MP. Screening for Depression in Adults: US Preventive Services Task Force Recommendation Statement. JAMA. 2016 Jan 26;315(4):380-7. doi: 10.1001/jama.2015.18392.
  PMID: 26813211
  citation: Sobocki P, Jonsson B, Angst J, Rehnberg C. Cost of depression in Europe. J Ment Health Policy Econ. 2006 Jun;9(2):87-98.
  PMID: 17007486
  citation: Steensma C, Loukine L, Orpana H, McRae L, Vachon J, Mo F, Boileau-Falardeau M, Reid C, Choi BC. Describing the population health burden of depression: health-adjusted life expectancy by depression status in Canada. Health Promot Chronic Dis Prev Can. 2016 Oct;36(10):205-213. doi: 10.24095/hpcdp.36.10.01.
  PMID: 27768557
  citation: Whiteford HA, Harris MG, McKeon G, Baxter A, Pennell C, Barendregt JJ, Wang J. Estimating remission from untreated major depression: a systematic review and meta-analysis. Psychol Med. 2013 Aug;43(8):1569-85. doi: 10.1017/S0033291712001717. Epub 2012 Aug 10.
  PMID: 22883473
  citation: Yildiz B, Schuring M, Knoef MG, Burdorf A. Chronic diseases and multimorbidity among unemployed and employed persons in the Netherlands: a register-based cross-sectional study. BMJ Open. 2020 Jul 2;10(7):e035037. doi: 10.1136/bmjopen-2019-035037.
  PMID: 32616488
  responsible party type: Principal Investigator
  investigator affiliation: Erasmus Medical Center
  investigator full name: Inge MCM de Kok
  investigator title: Principal Investigator
  mesh term: Depressive Disorder
  mesh term: Depression
  mesh term: Depressive Disorder, Major
  sharing ipd: Yes
  ipd description: Data of participants that did not grant permission to reuse their data for future research will have to be removed. Furthermore, further pseudonymisation and/or aggregation of the pseudonymised dataset would be required to secure the privacy of the participants and avoid indirect identification.
  The accessibility of the collected data could be important for potential follow-up research of this project and/or similar national/international projects that would like to perform analyses on our data because not much is known yet on the implementation of screening for MDD.
  ipd info type: Study Protocol
  ipd time frame: The data will be published within 10 months and will be available from then on.
  ipd access criteria: Open source publication