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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04447690
Other study ID # FDI UAN1901
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 3, 2020
Est. completion date December 31, 2020

Study information

Verified date May 2024
Source Universidad de los Andes, Chile
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 5553
Est. completion date December 31, 2020
Est. primary completion date September 4, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years old or older - Regular undergraduate students Exclusion Criteria: - Nonconsent

Study Design


Locations

Country Name City State
Chile Universidad de los Andes Santiago Metropolitana

Sponsors (2)

Lead Sponsor Collaborator
Universidad de los Andes, Chile Ministerio de Educación, Chile

Country where clinical trial is conducted

Chile, 

References & Publications (30)

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Fernandez-Mendoza J, Rodriguez-Munoz A, Vela-Bueno A, Olavarrieta-Bernardino S, Calhoun SL, Bixler EO, Vgontzas AN. The Spanish version of the Insomnia Severity Index: a confirmatory factor analysis. Sleep Med. 2012 Feb;13(2):207-10. doi: 10.1016/j.sleep.2011.06.019. Epub 2011 Dec 14. — View Citation

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. Erratum In: JAMA Psychiatry. 2019 Apr 1;76(4):447. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Interian A, Chesin M, Kline A, Miller R, St Hill L, Latorre M, Shcherbakov A, King A, Stanley B. Use of the Columbia-Suicide Severity Rating Scale (C-SSRS) to Classify Suicidal Behaviors. Arch Suicide Res. 2018 Apr-Jun;22(2):278-294. doi: 10.1080/13811118.2017.1334610. Epub 2017 Jul 17. — View Citation

Johnson J, Panagioti M. Interventions to Improve the Breaking of Bad or Difficult News by Physicians, Medical Students, and Interns/Residents: A Systematic Review and Meta-Analysis. Acad Med. 2018 Sep;93(9):1400-1412. doi: 10.1097/ACM.0000000000002308. — View 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. — View Citation

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. — View Citation

Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

* Note: There are 30 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 4 weeks
Primary 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. Up to 4 weeks
Primary 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.
Up to 4 weeks
Primary 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. Up to 4 weeks
Secondary 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.
Up to 4 weeks
Secondary General Health perception Self-perception on a subjective analogous scale of physical health Up to 4 weeks
Secondary General Menta Health perception Self-perception on a subjective analogous scale of mental health Up to 4 weeks
Secondary History of chronic diseases Ad hoc self-report survey of any previous chronic physical disease Up to 4 weeks
Secondary Physical activity Ad hoc self-report survey of minutes of physical activity during the past week Up to 4 weeks
Secondary Social activities Ad hoc self-report survey of time spent with friends or social gatherings Up to 4 weeks
Secondary 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. Up to 4 weeks
Secondary 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
Up to 4 weeks
Secondary 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. Up to 4 weeks
Secondary University violence and bullying Ad hoc self-report survey of violence suffered from teachers, administrative, auxiliaries, and other students; discrimination and bullying. Up to 4 weeks
Secondary 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). Up to 4 weeks
Secondary 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. Up to 4 weeks
Secondary 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.
Up to 4 weeks
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