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

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ClinicalTrials.gov Identifier: NCT04447690

Recruitment Status : Active, not recruiting

First Posted : June 25, 2020

Last Update Posted : September 18, 2020

Sponsor:

Collaborator:

Ministerio de Educación, Chile

Information provided by (Responsible Party):

Jorge Gaete, Universidad de los Andes, Chile

Tracking Information

First Submitted Date

January 24, 2020

First Posted Date

June 25, 2020

Last Update Posted Date

September 18, 2020

Actual Study Start Date

August 3, 2020

Actual Primary Completion Date

September 4, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

Depression, Anxiety and Stress Scale (DASS-21) [ Time Frame: Up to 4 weeks ]
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.
Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 4 weeks ]
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.
CAGE [ Time Frame: Up to 4 weeks ]
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.
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) [ Time Frame: Up to 4 weeks ]
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.

Original Primary Outcome Measures

Same as current

Change History

Current Secondary Outcome Measures

Sociodemographic characteristics [ Time Frame: Up to 4 weeks ]
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.
General Health perception [ Time Frame: Up to 4 weeks ]
Self-perception on a subjective analogous scale of physical health
General Menta Health perception [ Time Frame: Up to 4 weeks ]
Self-perception on a subjective analogous scale of mental health
History of chronic diseases [ Time Frame: Up to 4 weeks ]
Ad hoc self-report survey of any previous chronic physical disease
Physical activity [ Time Frame: Up to 4 weeks ]
Ad hoc self-report survey of minutes of physical activity during the past week
Social activities [ Time Frame: Up to 4 weeks ]
Ad hoc self-report survey of time spent with friends or social gatherings
Family functionality (APGAR) [ Time Frame: Up to 4 weeks ]
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.
History of personal and family mental health problems [ Time Frame: Up to 4 weeks ]
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
Insomnia Severity Index (ISI) [ Time Frame: Up to 4 weeks ]
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.
University violence and bullying [ Time Frame: Up to 4 weeks ]
Ad hoc self-report survey of violence suffered from teachers, administrative, auxiliaries, and other students; discrimination and bullying.
Sexuality and sexual health [ Time Frame: Up to 4 weeks ]
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).
Sense of Social and Academic Fit (SSAF) [ Time Frame: Up to 4 weeks ]
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.
COVID-19 questions [ Time Frame: Up to 4 weeks ]
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.

Original Secondary Outcome Measures

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

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

Official Title

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

Brief 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.

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.

Study Type

Observational

Study Design

Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition

Student
Mental Health
Depression, Anxiety
Depression
Anxiety
College Drinking
Stress

Intervention

Not Provided

Study Groups/Cohorts

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Active, not recruiting

Actual Enrollment

5553

Original Estimated Enrollment

3869

Estimated Study Completion Date

December 31, 2020

Actual Primary Completion Date

September 4, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

18 years old or older
Regular undergraduate students

Exclusion Criteria:

Nonconsent

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Contacts

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries

Chile

Removed Location Countries

Administrative Information

NCT Number

NCT04447690

Other Study ID Numbers

FDI UAN1901

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Jorge Gaete, Universidad de los Andes, Chile

Study Sponsor

Universidad de los Andes, Chile

Collaborators

Ministerio de Educación, Chile

Investigators

Study Chair:

Jorge Gaete Olivares, MD, PhD

Universidad de los Andes, Chile

PRS Account

Universidad de los Andes, Chile

Verification Date

September 2020

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