<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/NCT04447690</url>
  </required_header>
  <id_info>
    <org_study_id>FDI UAN1901</org_study_id>
    <nct_id>NCT04447690</nct_id>
  </id_info>
  <brief_title>Prevalence of Mental Health Problems Among Undergraduate Students at the Universidad de Los Andes</brief_title>
  <official_title>Prevalence of Mental Health Problems Among Undergraduate Students at the Universidad de Los Andes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de los Andes, Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministerio de Educación, Chile</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad de los Andes, Chile</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This project seeks to know the prevalence of mental health problems among undergraduate&#xD;
      students, through internationally and nationally validated screening instruments. The project&#xD;
      also aims to understand better the associated factors contributing to the mental health&#xD;
      problems of this population. Through the critical analysis of the results, our proposal aims&#xD;
      to establish the prevalence of anxiety, depression, suicidality and substance use, and the&#xD;
      association with socioeconomic features, academic stress, sense of belonging to the&#xD;
      university, interpersonal relationships, and sleep habits among other factors. Once finalized&#xD;
      the study, the results obtained will be disseminated to the university community and&#xD;
      published in peer-reviewed journals.&#xD;
&#xD;
      The results will help the university authorities to design and implement measures to prevent&#xD;
      mental health problems in this community.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background Mental health in the university population has become in recent years a common and&#xD;
      serious problem worldwide. There are various studies, systematic reviews and meta-analyses&#xD;
      that have been carried out over the past 5 years, which show very worrying figures. In the&#xD;
      USA, it has been described in medical students that between 6.0% and 66.5% have depression,&#xD;
      between 7.7% and 65.5% anxiety disorders, and between 12.2% and 96.7% refer having stress. In&#xD;
      China, on the other hand, a study was reported in 2016 that revealed a prevalence of&#xD;
      depression of 23.8%. In Latin America we find a study carried out in Brazil among medical&#xD;
      students, which shows a prevalence of depression of 30.6%, anxiety disorders of 32.9, and&#xD;
      stress of 49.9%, among other indicators described. In Chile, during 2019 appears the results&#xD;
      of the &quot;First National Survey of Mental Health among university students&quot;, surveying over 600&#xD;
      students from three universities in Chile. This study showed that 46% of the students&#xD;
      presented depressive symptoms, 46% had anxiety symptoms, 53.5% stress symptoms and 29.7%&#xD;
      presented all three symptoms simultaneously. In addition, 5.1% of the students reported&#xD;
      having suicidal thoughts at the time of the study.&#xD;
&#xD;
      There are multiple determinants that influence mental health, both social, biological, and&#xD;
      psychological factors. Within these, the socioeconomic levels of the families of origin and&#xD;
      the education attained by their parents stand out, but also the contexts of violence -in its&#xD;
      multiple forms- to which university students may be exposed, levels of stress for academic&#xD;
      reasons, discrimination for various reasons, in addition to poor health in general.&#xD;
&#xD;
      University students are a group that has certain characteristics in common that makes it&#xD;
      particularly vulnerable in terms of their mental health. Among these factors, we can mention:&#xD;
      the process of adaptation from the school environment to the university environment, the&#xD;
      vocational uncertainty, being subjected to a constant academic workload, responding with&#xD;
      demands of both their own and their environment (such as parents and society), and facing&#xD;
      worries about entering into the world of work. In short, passing through the university is a&#xD;
      period of constant changes, which demands self-management and support, but it also means an&#xD;
      adaptation process that can help to eventually develop mental health problems.&#xD;
&#xD;
      At Universidad de los Andes there are no official published figures on the prevalence of&#xD;
      mental health problems among university students, nor on possible associated factors among&#xD;
      its students. It is important to have a clear and precise current status, as this would allow&#xD;
      the implementation of prevention policies, interventions, and the creation of support&#xD;
      networks that can help students' mental health.&#xD;
&#xD;
      General Aim:&#xD;
&#xD;
      The general aim of this project is to describe the mental health of the students of the&#xD;
      Universidad de los Andes and its association with individual factors, especially academic&#xD;
      stress, sense of university belonging, peer violence, substance abuse, and sleep habits.&#xD;
&#xD;
      Methodology Participants. All regular undergraduate students from first to last year of&#xD;
      career and older than 18 years old from the Universidad de los Andes will be invited to&#xD;
      participate. The various academic units and faculties have offered support and will join the&#xD;
      study. Participation is voluntary.&#xD;
&#xD;
      Sample size. Random sampling will be considered for each stratum defined by the career and&#xD;
      its year, the sample size is determined from the number of enrolled. For this sample&#xD;
      calculation, it has been used as p = 0.1, considering that different studies have estimated&#xD;
      the prevalence of suicidal ideation in the last year of 10% (10). A non-response of 20% is&#xD;
      anticipated, therfore the sample size is increased by that percentage. A total of 4836&#xD;
      students are expected to participate.&#xD;
&#xD;
      Instruments. A detailed description of the instruments can be found in the Outcomes section&#xD;
      of this protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">September 4, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Depression, Anxiety and Stress Scale (DASS-21)</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Self-reported symptoms with the Depression, Anxiety and Stress Scale (DASS-21), which have 21 items, each scoring between 0 and 3, the minimum score is 0 and the maximum score of 63. The cut-off score for the depression subscale is 6, Anxiety is 5, Stress is 6.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Columbia-Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>The Columbia-Suicide Severity Rating Scale (C-SSRS) is a questionnaire used for suicide assessment. This scale has 6 items and each item has to be answered Yes or No. The total score is 6. A score of 0 is no ideation is present.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CAGE</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Self-report of harmful alcohol drinking. 4 items. CAGE stands for:&#xD;
C: Have you felt the need to Cut down drinking? A: Have you ever felt Annoyed by criticism of drinking? G: Have you had Guilty feelings about drinking? E: Do you ever take a morning Eye opener (a drink first thing in the morning to steady your nerves or get rid of a hangover)? The range score goes from 0 to 4. The point cut off is &gt;= 2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Adaptation of The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) interview model, including prescription and nonprescription drugs and vaping. It has 8 items exploring the frequency of substance use in the last 3 months (daily, weekly, yearly) and the problems associated with the use. It explores the use of 10 kinds of drugs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sociodemographic characteristics</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Ad hoc self-report survey:&#xD;
Current age&#xD;
University enrollment year&#xD;
Current years of study&#xD;
Sex&#xD;
Gender&#xD;
Civil status&#xD;
Parenting and number of child(s)&#xD;
Nationality&#xD;
Etnicity&#xD;
Ocupational situation: only study, part-time worker, fulltime worker and study&#xD;
Carrer&#xD;
Maximum parents studies degree: analphabet, school, undergraduate, postgraduate; complete or incomplete studies.&#xD;
Payment of studies: credit, schollarship, self-pay&#xD;
Travel time from home to campus: minutes, hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Health perception</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Self-perception on a subjective analogous scale of physical health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Menta Health perception</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Self-perception on a subjective analogous scale of mental health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>History of chronic diseases</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Ad hoc self-report survey of any previous chronic physical disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Ad hoc self-report survey of minutes of physical activity during the past week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social activities</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Ad hoc self-report survey of time spent with friends or social gatherings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family functionality (APGAR)</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Family functionality APGAR score: a 5-item measure of perceived family support in the domains of adaptation, partnership, growth, affection, and resolve. E.g. &quot;I find that my family accepts my wishes to take on new activities or make changes in my lifestyle&quot;. Scores range from 0 to 10, being 10 a total satisfaction with family functionality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>History of personal and family mental health problems</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Ad hoc self-report questionnaire of personal and family mental health history:&#xD;
Previous diagnosis of depression, bipolar disorder, panic attacks, anxiety disorders, eating disorders, ADHD.&#xD;
Current psychotherapy of psychiatric medication&#xD;
Family history of psychiatric disorders</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia Severity Index (ISI)</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Self-report of insomnia perception. it has 7 items, and responses can range from 0 to 4, where higher scores indicate more acute symptoms of insomnia. Scores ranges from 0 to 28. A clinical Insomnia threshold score of 15.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>University violence and bullying</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Ad hoc self-report survey of violence suffered from teachers, administrative, auxiliaries, and other students; discrimination and bullying.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexuality and sexual health</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Ad hoc self-report survey of sexual health, including sexual orientation, the current status of an emotional relationship, number of sex partners in the last year, history of Sexually Transmitted Disease (STD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sense of Social and Academic Fit (SSAF)</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Sense of Social and Academic Fit (SSAF) is a self-report questionnaire of 17 items, with responses on a Likert format from 1-7. It measures academic and social sense of belonging. The score is produced as the average of the scores reported in each item. The minimum score is 1 and the maximum score is 17. A higher score means higher sense of belonging.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COVID-19 questions</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Ad-hoc self-report survey of current perception and possible diagnosis of COVID-19:&#xD;
Fear or preoccupation about getting COVID-19&#xD;
Sense of severity if diagnosed with COVID-19&#xD;
Fear or preoccupation about a family member or friend to get COVID-19&#xD;
Current diagnosis of COVID-19&#xD;
A family member diagnosed with COVID19&#xD;
Sense of compliance with social isolation and quarantine&#xD;
Persons living with (family, friends, alone)&#xD;
Frequency of: going out of home, gather with others, virtual socialization, keeping a routine, exercise realized, recreative activities, meditation or prayer, seek information about the situation of COVID19&#xD;
Frequency of the following symptoms: nervousness, hopelessness, depression, amount of effort required to realize activities, self-value, anhedonia.</description>
  </secondary_outcome>
  <enrollment type="Actual">5553</enrollment>
  <condition>Student</condition>
  <condition>Mental Health</condition>
  <condition>Depression, Anxiety</condition>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <condition>College Drinking</condition>
  <condition>Stress</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Undergraduate regular students of every career from Universidad de los Andes, Chile.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years old or older&#xD;
&#xD;
          -  Regular undergraduate students&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Nonconsent&#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>Jorge Gaete Olivares, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Universidad de los Andes, Chile</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidad de los Andes</name>
      <address>
        <city>Santiago</city>
        <state>Metropolitana</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <link>
    <url>http://dx.doi.org/10.1590/1516-4446-2017-2223</url>
    <description>Mental health problems among medical students in Brazil: a systematic review and meta-analysis</description>
  </link>
  <link>
    <url>http://dx.doi.org/10.4067/S0717-92272014000300004</url>
    <description>Diagnostic of the prevalence of mental health disorders in college students and associated emotional risk factors</description>
  </link>
  <link>
    <url>http://www.tvu.cl/prensa/2019/04/29/encuesta-nacional-salud-mental-universitaria-44-de-los-estudiantes-se-han-sometido-a-tratamientos-psicologicos.html</url>
    <description>Encuesta Nacional Salud Mental Universitaria</description>
  </link>
  <link>
    <url>https://doi.org/10.1007/s11218-019-09496-4</url>
    <description>Bullying and social anxiety experiences in university learning situations</description>
  </link>
  <link>
    <url>https://scielo.conicyt.cl/scielo.php?script=sci_arttext&amp;pid=S0718-48082012000300005</url>
    <description>Depression Anxiety Stress Scales (DASS - 21): Validation of the Abbreviated Version in Chilean University Students</description>
  </link>
  <link>
    <url>https://link.springer.com/article/10.1023/A:1016014818163</url>
    <description>The depression anxiety stress scale-21: Spanish translation and validation with a Hispanic sample</description>
  </link>
  <link>
    <url>https://link.springer.com/article/10.1023/A:1011095624717</url>
    <description>Confirmatory Factor Analysis of the Depression-Anxiety-Stress Scales in Depressed and Anxious Patients</description>
  </link>
  <link>
    <url>http://www.scielo.org.co/scielo.php?script=sci_abstract&amp;pid=S0034-74502009000200006</url>
    <description>Psychometric Properties of the CAGE Questionnaire for Alcohol Abuse: Results of Three Analyses.</description>
  </link>
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  </reference>
  <reference>
    <citation>Saitz R, Lepore MF, Sullivan LM, Amaro H, Samet JH. Alcohol abuse and dependence in Latinos living in the United States: validation of the CAGE (4M) questions. Arch Intern Med. 1999 Apr 12;159(7):718-24. doi: 10.1001/archinte.159.7.718.</citation>
    <PMID>10218752</PMID>
  </reference>
  <reference>
    <citation>Dhalla S, Kopec JA. The CAGE questionnaire for alcohol misuse: a review of reliability and validity studies. Clin Invest Med. 2007;30(1):33-41. doi: 10.25011/cim.v30i1.447.</citation>
    <PMID>17716538</PMID>
  </reference>
  <reference>
    <citation>Ewing JA. Detecting alcoholism. The CAGE questionnaire. JAMA. 1984 Oct 12;252(14):1905-7. doi: 10.1001/jama.252.14.1905.</citation>
    <PMID>6471323</PMID>
  </reference>
  <reference>
    <citation>Bernadt MW, Mumford J, Taylor C, Smith B, Murray RM. Comparison of questionnaire and laboratory tests in the detection of excessive drinking and alcoholism. Lancet. 1982 Feb 6;1(8267):325-8. doi: 10.1016/s0140-6736(82)91579-3.</citation>
    <PMID>6120322</PMID>
  </reference>
  <reference>
    <citation>Knight JR, Sherritt L, Harris SK, Gates EC, Chang G. Validity of brief alcohol screening tests among adolescents: a comparison of the AUDIT, POSIT, CAGE, and CRAFFT. Alcohol Clin Exp Res. 2003 Jan;27(1):67-73. doi: 10.1097/01.ALC.0000046598.59317.3A.</citation>
    <PMID>12544008</PMID>
  </reference>
  <reference>
    <citation>WHO ASSIST Working Group. The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): development, reliability and feasibility. Addiction. 2002 Sep;97(9):1183-94. doi: 10.1046/j.1360-0443.2002.00185.x.</citation>
    <PMID>12199834</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>April 3, 2021</last_update_submitted>
  <last_update_submitted_qc>April 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de los Andes, Chile</investigator_affiliation>
    <investigator_full_name>Jorge Gaete</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>college students</keyword>
  <keyword>undergraduate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Alcohol Drinking in College</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04447690
org study id: FDI UAN1901
nct id: NCT04447690
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This project seeks to know the prevalence of mental health problems among undergraduate
      students, through internationally and nationally validated screening instruments. The project
      also aims to understand better the associated factors contributing to the mental health
      problems of this population. Through the critical analysis of the results, our proposal aims
      to establish the prevalence of anxiety, depression, suicidality and substance use, and the
      association with socioeconomic features, academic stress, sense of belonging to the
      university, interpersonal relationships, and sleep habits among other factors. Once finalized
      the study, the results obtained will be disseminated to the university community and
      published in peer-reviewed journals.

      The results will help the university authorities to design and implement measures to prevent
      mental health problems in this community.
Background Mental health in the university population has become in recent years a common and
      serious problem worldwide. There are various studies, systematic reviews and meta-analyses
      that have been carried out over the past 5 years, which show very worrying figures. In the
      USA, it has been described in medical students that between 6.0% and 66.5% have depression,
      between 7.7% and 65.5% anxiety disorders, and between 12.2% and 96.7% refer having stress. In
      China, on the other hand, a study was reported in 2016 that revealed a prevalence of
      depression of 23.8%. In Latin America we find a study carried out in Brazil among medical
      students, which shows a prevalence of depression of 30.6%, anxiety disorders of 32.9, and
      stress of 49.9%, among other indicators described. In Chile, during 2019 appears the results
      of the "First National Survey of Mental Health among university students", surveying over 600
      students from three universities in Chile. This study showed that 46% of the students
      presented depressive symptoms, 46% had anxiety symptoms, 53.5% stress symptoms and 29.7%
      presented all three symptoms simultaneously. In addition, 5.1% of the students reported
      having suicidal thoughts at the time of the study.

      There are multiple determinants that influence mental health, both social, biological, and
      psychological factors. Within these, the socioeconomic levels of the families of origin and
      the education attained by their parents stand out, but also the contexts of violence -in its
      multiple forms- to which university students may be exposed, levels of stress for academic
      reasons, discrimination for various reasons, in addition to poor health in general.

      University students are a group that has certain characteristics in common that makes it
      particularly vulnerable in terms of their mental health. Among these factors, we can mention:
      the process of adaptation from the school environment to the university environment, the
      vocational uncertainty, being subjected to a constant academic workload, responding with
      demands of both their own and their environment (such as parents and society), and facing
      worries about entering into the world of work. In short, passing through the university is a
      period of constant changes, which demands self-management and support, but it also means an
      adaptation process that can help to eventually develop mental health problems.

      At Universidad de los Andes there are no official published figures on the prevalence of
      mental health problems among university students, nor on possible associated factors among
      its students. It is important to have a clear and precise current status, as this would allow
      the implementation of prevention policies, interventions, and the creation of support
      networks that can help students' mental health.

      General Aim:

      The general aim of this project is to describe the mental health of the students of the
      Universidad de los Andes and its association with individual factors, especially academic
      stress, sense of university belonging, peer violence, substance abuse, and sleep habits.

      Methodology Participants. All regular undergraduate students from first to last year of
      career and older than 18 years old from the Universidad de los Andes will be invited to
      participate. The various academic units and faculties have offered support and will join the
      study. Participation is voluntary.

      Sample size. Random sampling will be considered for each stratum defined by the career and
      its year, the sample size is determined from the number of enrolled. For this sample
      calculation, it has been used as p = 0.1, considering that different studies have estimated
      the prevalence of suicidal ideation in the last year of 10% (10). A non-response of 20% is
      anticipated, therfore the sample size is increased by that percentage. A total of 4836
      students are expected to participate.

      Instruments. A detailed description of the instruments can be found in the Outcomes section
      of this protocol.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: Depression, Anxiety and Stress Scale (DASS-21)
time frame: Up to 4 weeks
description: Self-reported symptoms with the Depression, Anxiety and Stress Scale (DASS-21), which have 21 items, each scoring between 0 and 3, the minimum score is 0 and the maximum score of 63. The cut-off score for the depression subscale is 6, Anxiety is 5, Stress is 6.
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
time frame: Up to 4 weeks
description: The Columbia-Suicide Severity Rating Scale (C-SSRS) is a questionnaire used for suicide assessment. This scale has 6 items and each item has to be answered Yes or No. The total score is 6. A score of 0 is no ideation is present.
measure: CAGE
time frame: Up to 4 weeks
description: Self-report of harmful alcohol drinking. 4 items. CAGE stands for:
C: Have you felt the need to Cut down drinking? A: Have you ever felt Annoyed by criticism of drinking? G: Have you had Guilty feelings about drinking? E: Do you ever take a morning Eye opener (a drink first thing in the morning to steady your nerves or get rid of a hangover)? The range score goes from 0 to 4. The point cut off is >= 2.
measure: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
time frame: Up to 4 weeks
description: Adaptation of The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) interview model, including prescription and nonprescription drugs and vaping. It has 8 items exploring the frequency of substance use in the last 3 months (daily, weekly, yearly) and the problems associated with the use. It explores the use of 10 kinds of drugs.
measure: Sociodemographic characteristics
time frame: Up to 4 weeks
description: Ad hoc self-report survey:
Current age
University enrollment year
Current years of study
Sex
Gender
Civil status
Parenting and number of child(s)
Nationality
Etnicity
Ocupational situation: only study, part-time worker, fulltime worker and study
Carrer
Maximum parents studies degree: analphabet, school, undergraduate, postgraduate; complete or incomplete studies.
Payment of studies: credit, schollarship, self-pay
Travel time from home to campus: minutes, hours.
measure: General Health perception
time frame: Up to 4 weeks
description: Self-perception on a subjective analogous scale of physical health
measure: General Menta Health perception
time frame: Up to 4 weeks
description: Self-perception on a subjective analogous scale of mental health
measure: History of chronic diseases
time frame: Up to 4 weeks
description: Ad hoc self-report survey of any previous chronic physical disease
measure: Physical activity
time frame: Up to 4 weeks
description: Ad hoc self-report survey of minutes of physical activity during the past week
measure: Social activities
time frame: Up to 4 weeks
description: Ad hoc self-report survey of time spent with friends or social gatherings
measure: Family functionality (APGAR)
time frame: Up to 4 weeks
description: Family functionality APGAR score: a 5-item measure of perceived family support in the domains of adaptation, partnership, growth, affection, and resolve. E.g. "I find that my family accepts my wishes to take on new activities or make changes in my lifestyle". Scores range from 0 to 10, being 10 a total satisfaction with family functionality.
measure: History of personal and family mental health problems
time frame: Up to 4 weeks
description: Ad hoc self-report questionnaire of personal and family mental health history:
Previous diagnosis of depression, bipolar disorder, panic attacks, anxiety disorders, eating disorders, ADHD.
Current psychotherapy of psychiatric medication
Family history of psychiatric disorders
measure: Insomnia Severity Index (ISI)
time frame: Up to 4 weeks
description: Self-report of insomnia perception. it has 7 items, and responses can range from 0 to 4, where higher scores indicate more acute symptoms of insomnia. Scores ranges from 0 to 28. A clinical Insomnia threshold score of 15.
measure: University violence and bullying
time frame: Up to 4 weeks
description: Ad hoc self-report survey of violence suffered from teachers, administrative, auxiliaries, and other students; discrimination and bullying.
measure: Sexuality and sexual health
time frame: Up to 4 weeks
description: Ad hoc self-report survey of sexual health, including sexual orientation, the current status of an emotional relationship, number of sex partners in the last year, history of Sexually Transmitted Disease (STD).
measure: Sense of Social and Academic Fit (SSAF)
time frame: Up to 4 weeks
description: Sense of Social and Academic Fit (SSAF) is a self-report questionnaire of 17 items, with responses on a Likert format from 1-7. It measures academic and social sense of belonging. The score is produced as the average of the scores reported in each item. The minimum score is 1 and the maximum score is 17. A higher score means higher sense of belonging.
measure: COVID-19 questions
time frame: Up to 4 weeks
description: Ad-hoc self-report survey of current perception and possible diagnosis of COVID-19:
Fear or preoccupation about getting COVID-19
Sense of severity if diagnosed with COVID-19
Fear or preoccupation about a family member or friend to get COVID-19
Current diagnosis of COVID-19
A family member diagnosed with COVID19
Sense of compliance with social isolation and quarantine
Persons living with (family, friends, alone)
Frequency of: going out of home, gather with others, virtual socialization, keeping a routine, exercise realized, recreative activities, meditation or prayer, seek information about the situation of COVID19
Frequency of the following symptoms: nervousness, hopelessness, depression, amount of effort required to realize activities, self-value, anhedonia.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jorge Gaete Olivares, MD, PhD
role: Study Chair
affiliation: Universidad de los Andes, Chile
facility: 
country: Chile
url: http://dx.doi.org/10.1590/1516-4446-2017-2223
description: Mental health problems among medical students in Brazil: a systematic review and meta-analysis
url: http://dx.doi.org/10.4067/S0717-92272014000300004
description: Diagnostic of the prevalence of mental health disorders in college students and associated emotional risk factors
url: http://www.tvu.cl/prensa/2019/04/29/encuesta-nacional-salud-mental-universitaria-44-de-los-estudiantes-se-han-sometido-a-tratamientos-psicologicos.html
description: Encuesta Nacional Salud Mental Universitaria
url: https://doi.org/10.1007/s11218-019-09496-4
description: Bullying and social anxiety experiences in university learning situations
url: https://scielo.conicyt.cl/scielo.php?script=sci_arttext&pid=S0718-48082012000300005
description: Depression Anxiety Stress Scales (DASS - 21): Validation of the Abbreviated Version in Chilean University Students
url: https://link.springer.com/article/10.1023/A:1016014818163
description: The depression anxiety stress scale-21: Spanish translation and validation with a Hispanic sample
url: https://link.springer.com/article/10.1023/A:1011095624717
description: Confirmatory Factor Analysis of the Depression-Anxiety-Stress Scales in Depressed and Anxious Patients
url: http://www.scielo.org.co/scielo.php?script=sci_abstract&pid=S0034-74502009000200006
description: Psychometric Properties of the CAGE Questionnaire for Alcohol Abuse: Results of Three Analyses.
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citation: Saitz R, Lepore MF, Sullivan LM, Amaro H, Samet JH. Alcohol abuse and dependence in Latinos living in the United States: validation of the CAGE (4M) questions. Arch Intern Med. 1999 Apr 12;159(7):718-24. doi: 10.1001/archinte.159.7.718.
PMID: 10218752
citation: Dhalla S, Kopec JA. The CAGE questionnaire for alcohol misuse: a review of reliability and validity studies. Clin Invest Med. 2007;30(1):33-41. doi: 10.25011/cim.v30i1.447.
PMID: 17716538
citation: Ewing JA. Detecting alcoholism. The CAGE questionnaire. JAMA. 1984 Oct 12;252(14):1905-7. doi: 10.1001/jama.252.14.1905.
PMID: 6471323
citation: Bernadt MW, Mumford J, Taylor C, Smith B, Murray RM. Comparison of questionnaire and laboratory tests in the detection of excessive drinking and alcoholism. Lancet. 1982 Feb 6;1(8267):325-8. doi: 10.1016/s0140-6736(82)91579-3.
PMID: 6120322
citation: Knight JR, Sherritt L, Harris SK, Gates EC, Chang G. Validity of brief alcohol screening tests among adolescents: a comparison of the AUDIT, POSIT, CAGE, and CRAFFT. Alcohol Clin Exp Res. 2003 Jan;27(1):67-73. doi: 10.1097/01.ALC.0000046598.59317.3A.
PMID: 12544008
citation: WHO ASSIST Working Group. The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): development, reliability and feasibility. Addiction. 2002 Sep;97(9):1183-94. doi: 10.1046/j.1360-0443.2002.00185.x.
PMID: 12199834
responsible party type: Principal Investigator
investigator affiliation: Universidad de los Andes, Chile
investigator full name: Jorge Gaete
investigator title: Associate Professor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Anxiety Disorders
mesh term: Alcohol Drinking in College
sharing ipd: No