Population Screening Using Smartphone in Milpa Alta (Smart-screen)

Massive Mental Health Screening Using Smartphone in Milpa Alta Community, Mexico.

The objective of this study is to make a suicide screening in the entire population of Milpa Alta (approximately 150,000 inhabitants), taking 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 .

It is expected that 70% of the population between 15 and 70 years old can do so directly with their own Smartphone, although web access posts will be enabled in educational and municipal units to avoid discrimination based on age or access to technology.

Our main hypothesis argues that the early identification of people at risk in almost the entire community can be done with an App for Smartphone, serving to depict a map of mental health and related needs of the population, serving for the planning of healthcare services of the local environment, and ultimately for the best assistance of groups and individuals with greater needs through their identification and early reference to medical assistance.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

150000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Mexico City, Mexico, 12000
        • Recruiting
        • Alcaldía Milpa Alta. Ciudad de México
        • Contact:
        • Principal Investigator:
          • Enrique Baca-García, Dr
        • Principal Investigator:
          • Fuensanta Aroca, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community composed of school population between 15 and 24 years of the educational institutions of Milpa Alta, and adult population of the municipality of Milpa Alta.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Milpa Alta inhabitants
Population among 15 and 70 years old
Smartphone app with MeMind questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suicidal ideation
Time Frame: 1 Day

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: 1 Day

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
Anxiety
Time Frame: 1 Day

Participants will be asked to complete a questionnaire regarding possible symptoms related to anxiety.

GAD-7 (only screening questions) is emcompassed into Memind for this purpose.

1 Day
Drug Utilization
Time Frame: 1 Day

Participants will be asked to complete a questionnaire regarding possible symptoms related to anxiety.

DAST (only questions 1,6,7) is emcompassed into Memind for this purpose.

1 Day
Alcohol Drinking
Time Frame: 1 Day

Participants will be asked to complete a questionnaire regarding possible symptoms related to alcohol abuse.

Alcohol Use Disorders Identification Test (AUDIT-C)

1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2019

Primary Completion (Anticipated)

January 23, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

August 22, 2019

First Submitted That Met QC Criteria

August 22, 2019

First Posted (Actual)

August 26, 2019

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

July 1, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be available for researchers upon request

IPD Sharing Access Criteria

Upon request to Enrique Baca Garcia (enrique.baca@uam.es)

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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