Anxiety, Depression and Substance Use in Undergraduate Health Science Students During the Covid-19 Pandemic.

NCT05075629 | Completed DMC

• 1 other identifier: UW/FP/IC/PSICOLOGIA/2021/002
• Study Type: observational
• Target: 384
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; Substance-Related Disorders

Outcome Measures

Primary Outcomes (3)

• Patient Health Questionnaire-9 (PHQ-9)

  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 weeks

• Generalized Anxiety Disorder scale (GAD-7)

  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.

  2 weeks

• Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

  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.

  3 months

Secondary Outcomes (1)

• The hospital anxiety and depression scale (HADS)

  2 weeks

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Mexican university health students

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Westhill, Facultad de Psicología: lead

Study Sites (1)

Alejandro Hernández Posadas

Mexico City, Mexico

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Chemically-Induced Disorders

Study Officials

• Alejandro Hernández Posadas, Master's Degree

  Universidad Westhill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 13, 2021
• Study Start: October 12, 2021
• Primary Completion: October 14, 2021
• Study Completion: March 31, 2022
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

ME (1)