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StudentNCT04447690

Prevalence of Mental Health Problems Among Undergraduate Students at the Universidad de Los Andes

An observational study of Student and Mental Health, run by Universidad de los Andes, Chile at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Student, Mental Health, Depression, Anxiety
How many people
5,553 participants
Where
1 siteChile
Study dates
3 Aug 2020to 31 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Undergraduate regular students of every career from Universidad de los Andes, Chile.

Who may be able to join

  • 18 years old or older
  • Regular undergraduate students

Who cannot join

  • Nonconsent

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Universidad de los Andes

    Santiago, Santiago Metropolitan

Other trials in Chile

About this study

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.

Read the detailed description

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.

Keywords
college students, undergraduate
Medical subject headings
Psychological Well-Being, Depression, Anxiety Disorders, Alcohol Drinking in College

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depression, Anxiety and Stress Scale (DASS-21)

    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.

    Measured: Up to 4 weeks

  2. Columbia-Suicide Severity Rating Scale (C-SSRS)

    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.

    Measured: Up to 4 weeks

  3. CAGE

    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.

    Measured: Up to 4 weeks

  4. Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

    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.

    Measured: Up to 4 weeks

Secondary outcomes (13)

  1. Sociodemographic characteristics

    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.

    Measured: Up to 4 weeks

  2. General Health perception

    Self-perception on a subjective analogous scale of physical health

    Measured: Up to 4 weeks

  3. General Menta Health perception

    Self-perception on a subjective analogous scale of mental health

    Measured: Up to 4 weeks

  4. History of chronic diseases

    Ad hoc self-report survey of any previous chronic physical disease

    Measured: Up to 4 weeks

  5. Physical activity

    Ad hoc self-report survey of minutes of physical activity during the past week

    Measured: Up to 4 weeks

  6. Social activities

    Ad hoc self-report survey of time spent with friends or social gatherings

    Measured: Up to 4 weeks

  7. Family functionality (APGAR)

    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.

    Measured: Up to 4 weeks

  8. History of personal and family mental health problems

    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

    Measured: Up to 4 weeks

  9. Insomnia Severity Index (ISI)

    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.

    Measured: Up to 4 weeks

  10. University violence and bullying

    Ad hoc self-report survey of violence suffered from teachers, administrative, auxiliaries, and other students; discrimination and bullying.

    Measured: Up to 4 weeks

  11. Sexuality and sexual health

    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).

    Measured: Up to 4 weeks

  12. Sense of Social and Academic Fit (SSAF)

    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.

    Measured: Up to 4 weeks

  13. COVID-19 questions

    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.

    Measured: Up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2020
  2. Study start3 Aug 2020
  3. Primary completion4 Sep 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
5,553 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04447690
Sponsor's protocol ID
FDI UAN1901
Status last verified
May 2024
First submitted
24 Jan 2020
Last updated
17 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hope V, Henderson M. Medical student depression, anxiety and distress outside North America: a systematic review. Med Educ. 2014 Oct;48(10):963-79. doi: 10.1111/medu.12512.

    PubMed 25200017

  • Lei XY, Xiao LM, Liu YN, Li YM. Prevalence of Depression among Chinese University Students: A Meta-Analysis. PLoS One. 2016 Apr 12;11(4):e0153454. doi: 10.1371/journal.pone.0153454. eCollection 2016.

    PubMed 27070790

  • Stapinski LA, Montgomery AA, Araya R. Anxiety, depression and risk of cannabis use: Examining the internalising pathway to use among Chilean adolescents. Drug Alcohol Depend. 2016 Sep 1;166:109-15. doi: 10.1016/j.drugalcdep.2016.06.032. Epub 2016 Jul 1.

    PubMed 27427415

  • Gobbi G, Atkin T, Zytynski T, Wang S, Askari S, Boruff J, Ware M, Marmorstein N, Cipriani A, Dendukuri N, Mayo N. Association of Cannabis Use in Adolescence and Risk of Depression, Anxiety, and Suicidality in Young Adulthood: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2019 Apr 1;76(4):426-434. doi: 10.1001/jamapsychiatry.2018.4500.

    PubMed 30758486

  • Pigeon WR, Bishop TM, Krueger KM. Insomnia as a Precipitating Factor in New Onset Mental Illness: a Systematic Review of Recent Findings. Curr Psychiatry Rep. 2017 Aug;19(8):44. doi: 10.1007/s11920-017-0802-x.

    PubMed 28616860

  • Taylor DJ, Gardner CE, Bramoweth AD, Williams JM, Roane BM, Grieser EA, Tatum JI. Insomnia and mental health in college students. Behav Sleep Med. 2011;9(2):107-16. doi: 10.1080/15402002.2011.557992.

    PubMed 21491233

  • Hrafnkelsdottir SM, Brychta RJ, Rognvaldsdottir V, Gestsdottir S, Chen KY, Johannsson E, Guethmundsdottir SL, Arngrimsson SA. Less screen time and more frequent vigorous physical activity is associated with lower risk of reporting negative mental health symptoms among Icelandic adolescents. PLoS One. 2018 Apr 26;13(4):e0196286. doi: 10.1371/journal.pone.0196286. eCollection 2018.

    PubMed 29698499

  • Feng Q, Zhang QL, Du Y, Ye YL, He QQ. Associations of physical activity, screen time with depression, anxiety and sleep quality among Chinese college freshmen. PLoS One. 2014 Jun 25;9(6):e100914. doi: 10.1371/journal.pone.0100914. eCollection 2014.

    PubMed 24964250

  • Wu X, Tao S, Zhang Y, Zhang S, Tao F. Low physical activity and high screen time can increase the risks of mental health problems and poor sleep quality among Chinese college students. PLoS One. 2015 Mar 18;10(3):e0119607. doi: 10.1371/journal.pone.0119607. eCollection 2015.

    PubMed 25786030

  • Ploderl M, Tremblay P. Mental health of sexual minorities. A systematic review. Int Rev Psychiatry. 2015;27(5):367-85. doi: 10.3109/09540261.2015.1083949. Epub 2015 Nov 9.

    PubMed 26552495

  • Stojanovic-Tasic M, Grgurevic A, Cvetkovic J, Grgurevic U, Trajkovic G. Association between somatic diseases and symptoms of depression and anxiety among Belgrade University students. Med Glas (Zenica). 2014 Aug;11(2):373-8.

    PubMed 25082256

  • Oswalt SB, Wyatt TJ. Sexual orientation and differences in mental health, stress, and academic performance in a national sample of U.S. college students. J Homosex. 2011;58(9):1255-80. doi: 10.1080/00918369.2011.605738.

    PubMed 21957858

  • Mortier P, Auerbach RP, Alonso J, Bantjes J, Benjet C, Cuijpers P, Ebert DD, Green JG, Hasking P, Nock MK, O'Neill S, Pinder-Amaker S, Sampson NA, Vilagut G, Zaslavsky AM, Bruffaerts R, Kessler RC; WHO WMH-ICS Collaborators. Suicidal Thoughts and Behaviors Among First-Year College Students: Results From the WMH-ICS Project. J Am Acad Child Adolesc Psychiatry. 2018 Apr;57(4):263-273.e1. doi: 10.1016/j.jaac.2018.01.018. Epub 2018 Feb 13.

    PubMed 29588052

  • Bastounis A, Callaghan P, Banerjee A, Michail M. The effectiveness of the Penn Resiliency Programme (PRP) and its adapted versions in reducing depression and anxiety and improving explanatory style: A systematic review and meta-analysis. J Adolesc. 2016 Oct;52:37-48. doi: 10.1016/j.adolescence.2016.07.004. Epub 2016 Aug 2.

    PubMed 27494740

  • Huang J, Nigatu YT, Smail-Crevier R, Zhang X, Wang J. Interventions for common mental health problems among university and college students: A systematic review and meta-analysis of randomized controlled trials. J Psychiatr Res. 2018 Dec;107:1-10. doi: 10.1016/j.jpsychires.2018.09.018. Epub 2018 Sep 29.

    PubMed 30300732

Questions about this trial

What is this clinical trial studying?

An observational study of Student and Mental Health, run by Universidad de los Andes, Chile at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression, Anxiety and Stress Scale (DASS-21) (time frame: Up to 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04447690, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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