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Mental Health in Undergraduate Health Science Students During the Covid-19 Pandemic.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05075629
Recruitment Status : Completed
First Posted : October 13, 2021
Last Update Posted : August 9, 2022
Information provided by (Responsible Party):
Universidad Westhill, Facultad de Psicología

Brief Summary:
A study will be conducted with a quantitative approach with correlational scope, observational analytical study, prospective cross-sectional. The objective is to compare the levels of anxious symptomatology, depressive symptomatology and substance use in university students who were exposed to SARS-CoV-2 with those who were not.

Condition or disease
Depression Anxiety Substance-Related Disorders

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Study Type : Observational
Actual Enrollment : 384 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Mental Health in Undergraduate Health Science Students During the Covid-19 Pandemic.
Actual Study Start Date : October 12, 2021
Actual Primary Completion Date : October 14, 2021
Actual Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 2 weeks ]
    It is a cross-culturally validated instrument and its confirmatory factor analysis suggested that the one-factor structure was a reasonably good fit. The internal consistency of the PHQ-9 was good (Cronbach's alpha> = 0.8) overall and for subgroups defined by gender, literacy, and age. The PHQ-9 demonstrated good predictive validity: participants with a PHQ-9 diagnosis of depression had lower quality of life scores on the overall WHOQOL-BREF scale and on each of its domains. Using the results of the PHQ-9 as a gold standard, the optimal cut-off score of 10. Definition of the variable: A depressive episode is characterized by a period of depressed mood or decreased interest in activities occurring most of the day, almost every day for a period lasting at least two weeks accompanied by other symptoms such as difficulty concentrating, feelings of worthlessness or excessive or inappropriate guilt.

  2. Generalized Anxiety Disorder scale (GAD-7) [ Time Frame: 2 weeks ]
    The GAD-7 consists of the 7 items with the highest correlation with the total score of the 13-item scale (r = 0.75-0.85). It is an instrument with cross-cultural validation and analysis of receiver operating characteristics with this set of items showed an area under the curve (0.906) and scales with as much as the full 13-item set. These 7 items also had the highest rank correlations in the development sample (n = 1184) and the 2 replication samples (n = 965 and n = 591). The 2 core criteria (A and B) of the DSM-IV definition of GAD are captured by the first 3 items of the scale.26 Of note, 6 of the 7 items had the highest divergent validity (ie, the largest difference between item-total scale score correlation and item-PHQ-8 depression score correlation [Δ r = 0.16-0.21]). Because each of the 7 items is scored from 0 to 3, the GAD-7 scale score ranges from 0 to 21.

  3. Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) [ Time Frame: 3 months ]
    Validation and cultural adaptation was carried out in university students through a non-experimental ex post facto study with 1,176 undergraduate students, mostly women (70.1%) aged 18 to 23 years (89.5%) and unmarried (87.5%). Concurrent validity was obtained by factor analysis and reliability and correlation tests between the alcohol subscale and AUDIT, the Tobacco subscale and Fargerström's Tes, and the marijuana subscale and the DAST-20. The results found adequate reliability coefficients for the ASSIST subscales for tobacco (alpha = 0.83), alcohol (alpha = 0.76) and marijuana (alpha = 0.73). Regarding interscale correlation, significant correlations were only found with the AUDIT (r = 0.71) and the alcohol subscale.

Secondary Outcome Measures :
  1. The hospital anxiety and depression scale (HADS) [ Time Frame: 2 weeks ]
    The scale was adapted and validated by López-Alveranga et al. (2002). The scale is composed of 14 items and is a Likert-type scale ranging from zero to three, with a minimum score of zero and a maximum score of 21. A score equal to or greater than eight indicates the presence of a probable case of depression. Its reliability is good (α =.86).

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mexican university health students

Inclusion Criteria:

  • Be an active undergraduate student at any university
  • Be currently taking at least one subject at the University.
  • Agree to voluntarily participate in the study.
  • Sign the informed consent form.

Exclusion Criteria:

  • Be studying a postgraduate course at the University
  • Students of the University who are receiving psychological or psychiatric treatment during the period of the study.
  • Not currently taking any course at the University.
  • Those participants who do not answer the scales completely.
  • Tener un diagnóstico confirmado de Covid-19 en las últimas 2 semanas

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05075629

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Alejandro Hernández Posadas
Ciudad de México, Mexico
Sponsors and Collaborators
Universidad Westhill, Facultad de Psicología
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Principal Investigator: Alejandro Hernández Posadas, Master's Degree Universidad Westhill
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Responsible Party: Universidad Westhill, Facultad de Psicología
ClinicalTrials.gov Identifier: NCT05075629    
Other Study ID Numbers: UW/FP/IC/PSICOLOGIA/2021/002
First Posted: October 13, 2021    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Chemically-Induced Disorders
Mental Disorders