Depression Clinical Trial
— TEDUCAOfficial title:
Massive Mental Health Screening Using Smartphones in 24 Pre-graduate Education Centers in Mexico City: TEDUCA Survey Protocol
Verified date | July 2020 |
Source | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The objective of this study is to make a massive suicide risk and social behavior assessment
in 24 pre-graduate education centers in Mexico City (approximately 30,000 students aged
between 15 and 22 years), taking also into account other outcomes such as depression,
anxiety, alcohol and drugs. For this, an app for Smartphone (MeMind) or a web platform
(www.MeMind.net) will be used in which the participants will take a self-administered
questionnaire, composed of several psychometric instruments.
Our main hypothesis is that identification of suicide risk in the Mexico City's student
community is feasible using their own smartphones and can serve as both a population
screening tool for early specialist referral, as well as a tool for evaluating social
behavior strategies and their relation to suicide behavior.
Status | Recruiting |
Enrollment | 30000 |
Est. completion date | August 2020 |
Est. primary completion date | July 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 22 Years |
Eligibility |
Inclusion Criteria: 1. Use a smartphone as personal or computer terminals enabled by the municipality of Milpa Alta or educational services. 2. Be able to understand the nature, purpose and methodology of the study. 3. Accept participation in the study and check the corresponding box in the app to verify that the informed consent has been expressly given. Exclusion Criteria: 1. Subject deprived of liberty (by judicial or administrative decision) 2. Subject protected by law (guardianship or conservatorship) |
Country | Name | City | State |
---|---|---|---|
Mexico | Alcaldía Milpa Alta. Ciudad de México | Mexico City |
Lead Sponsor | Collaborator |
---|---|
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | Gobierno de la Ciudad de Mexico, Instituciones Educativas de nivel Medio Superior (IEMS) de Ciudad de México, Universidad Nacional Autonoma de Mexico |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Suicidal ideation | Columbia-Suicide Severity Rating Scale (C-SSRS) is encompassed into MeMind for this purpose. In C-SSRS, four constructs are measured. The first is the severity of ideation, which is rated on a 5-point ordinal scale from 1="wish to be dead" to 5="suicidal intent with plan". The second is the intensity of ideation, which comprises 5 items, each rated on a 5-point ordinal scale: frequency, duration, controllability, deterrents, and reason for ideation. The third is the behavior, which is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and nonsuicidal self-injurious behavior. And the fourth is the lethality, which assesses actual attempts; actual lethality is rated on a 6-point ordinal scale. Results are coded in the instrument itself with colored labels that indicates definitions of suicidal ideation and behavior, quantify both of them and gauge their severity. Definitions are available elsewhere (http://cssrs.columbia.edu). |
1 Day | |
Primary | Social Behavior | The assessment of social interaction will be carried out through six games that expose the participant to decision-making in preset environments with very simple and easily understandable rules (Dictator's Game, Prisoner's Dilemma, Loss Aversion, Risk Aversion, Trust Game or The Investment Game, and Ambiguity Aversion). | 1 Day | |
Secondary | Depression | Participants will be asked to complete a questionnaire regarding possible symptoms related to depression. PHQ-9 questionnaire is emcompassed into Memind for this purpose. |
1 Day | |
Secondary | Anxiety | Participants will be asked to complete a questionnaire regarding possible symptoms related to anxiety. GAD-7 (only screeni |
1 Day | |
Secondary | Drug Utilization | Participants will be asked to complete a questionnaire regarding possible symptoms related to drug abuse. DAST (only questions 1,6,7) is emcompassed into Memind for this purpose. |
1 Day | |
Secondary | Alcohol Drinking | Participants will be asked to complete a questionnaire regarding possible symptoms related to alcohol abuse. Alcohol Use Disorders Identification Test (AUDIT-C) |
1 Day |
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