DepressionNCT05190107
Depression, Anxiety and Stress in High School
An observational study of Depression and Anxiety, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
Background: Social isolation secondary to the pandemic can predispose the population to mental health issues in the future, especially teenagers. The Depression, Anxiety, and Stress Scale (DASS) is a valuable self-report scale since it may be used to screen for anxiety, depression, and stress in one questionnaire. Read more about this study
- Who is it for?
- Ages 14 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Stress
- What is being tested?
- DASS-21 scale
- How many people
- 3,112 participants
- Where
- 1 siteMexico
- Study dates
- 1 May 2021to 10 Dec 2021
- 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 14 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescents from 14 to 22 years old with an average age of 16 years are high school students.
Who may be able to join
- Adolescents from 14 to 22 years old.
- That they voluntarily agree to participate, and consent.
Who cannot join
- Adolescents with depression, anxiety, and stress disorders previously detected
- Patients in psychiatric treatment for depression, anxiety, or stress.
- Participants who don´t consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Depression, Anxiety and Stress in High School Students: A Survey Study in Western Mexico
Background: Social isolation secondary to the pandemic can predispose the population to mental health issues in the future, especially teenagers. The Depression, Anxiety, and Stress Scale (DASS) is a valuable self-report scale since it may be used to screen for anxiety, depression, and stress in one questionnaire. In the last years, it has been observed effective in detecting these symptoms in teenagers.
Aims: Identify the prevalence of depression, anxiety, and stress in high school students during the COVID-19 pandemic This is an observational cross-sectional study.
For this study, the validated Spanish version of DASS-21 will be used. Qualitative variables will be evaluated through central tendencies, such as mean, standard deviation, and frequencies. The inferential analysis of categorical variables will be performed using the chi-squared test, analysis of variance (ANOVA), or Kruskal Wallis test as appropriate. For quantitative variables, Student's t-test or Mann Whitney U test will be performed depending on their distribution.
- Conditions
- Depression, Anxiety, Stress
- Being tested
- DASS-21 scale
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASS-21 scaleDiagnostic test
Each construct consists of 7 questions. The participants must select the answer that better represents their feelings over the last week in each scenario. Each question has a Likert scale of 4 options where 0 represents "did not apply to me" to 3 "applied to me very much.
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Score
the Depression, Anxiety and Stress Scale 21 (DASS-21) is an inventory that will be used to identify the presence and intensity of depressive, anxiety and stress. For depression the cutoff scores are: Normal: 0-9, Mild: 10-12, Moderate:13-20, Severe: 21-27, and Extremely severe: 28-42.
Measured: Baseline
Anxiety Score
the Depression, Anxiety and Stress Scale 21 (DASS-21) is an inventory that will be used to identify the presence and intensity of depressive, anxiety and stress. For anxiety the cutoff scores are: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe:15-19, and Extremely severe: 20-42.
Measured: Baseline
Stress Score
the Depression, Anxiety and Stress Scale 21 (DASS-21) is an inventory that will be used to identify the presence and intensity of depressive, anxiety and stress. For stress the cutoff scores are: Normal: 0-10, Mild:11-18, Moderate:19-26, Severe: 27-34, and Extremely severe: 35-42.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 May 2021
- Primary completion1 Nov 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 3,112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190107
- Sponsor's protocol ID
- DASSH
- Status last verified
- Dec 2021
- First submitted
- 10 Dec 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Depression, Anxiety and Stress in High School Students: A Survey Study in Western Mexico
- ClinicalTrials.gov ID
- NCT05190107
- Acronym / sponsor ID
- DASSH
- Conditions
- Depression, Anxiety, Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,112 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Social isolation secondary to the pandemic can predispose the population to mental health issues in the future, especially teenagers. The Depression, Anxiety, and Stress Scale (DASS) is a valuable self-report scale since it may be used to screen for anxiety, depression, and stress in one questionnaire. In the last years, it has been observed effective in detecting these symptoms in teenagers.
Aims: Identify the prevalence of depression, anxiety, and stress in high school students during the COVID-19 pandemic This is an observational cross-sectional study.
For this study, the validated Spanish version of DASS-21 will be used. Qualitative variables will be evaluated through central tendencies, such as mean, standard deviation, and frequencies. The inferential analysis of categorical variables will be performed using the chi-squared test, analysis of variance (ANOVA), or Kruskal Wallis test as appropriate. For quantitative variables, Student's t-test or Mann Whitney U test will be performed depending on their distribution.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 14 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescents from 14 to 22 years old with an average age of 16 years are high school students.
Key inclusion criteria (2 listed)
- Adolescents from 14 to 22 years old.
- That they voluntarily agree to participate, and consent.
Key exclusion criteria (3 listed)
- Adolescents with depression, anxiety, and stress disorders previously detected
- Patients in psychiatric treatment for depression, anxiety, or stress.
- Participants who don´t consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DASS-21 scaleEach construct consists of 7 questions. The participants must select the answer that better represents their feelings over the last week in each scenario. Each question has a Likert scale of 4 options where 0 represents "did not apply to me" to 3 "applied to me very much. | Diagnostic test | – |
Primary outcome
Depression Score
Time frame: Baseline
the Depression, Anxiety and Stress Scale 21 (DASS-21) is an inventory that will be used to identify the presence and intensity of depressive, anxiety and stress. For depression the cutoff scores are: Normal: 0-9, Mild: 10-12, Moderate:13-20, Severe: 21-27, and Extremely severe: 28-42.
Anxiety Score
Time frame: Baseline
the Depression, Anxiety and Stress Scale 21 (DASS-21) is an inventory that will be used to identify the presence and intensity of depressive, anxiety and stress. For anxiety the cutoff scores are: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe:15-19, and Extremely severe: 20-42.
Stress Score
Time frame: Baseline
the Depression, Anxiety and Stress Scale 21 (DASS-21) is an inventory that will be used to identify the presence and intensity of depressive, anxiety and stress. For stress the cutoff scores are: Normal: 0-10, Mild:11-18, Moderate:19-26, Severe: 27-34, and Extremely severe: 35-42.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 3 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 13 Jan 2022. 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 Mexico. 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 Score (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2022.