Suicidal IdeationSmart-screenNCT04067063
Population Screening Using Smartphone in Milpa Alta
An observational study of Suicidal Ideation and Depression, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Suicidal Ideation, Depression, Depressive Disorder
- What is being tested?
- Self-administered evaluation questionnaire
- How many people
- 150,000 participants
- Where
- 1 siteMexico
- Study dates
- 26 Aug 2019to Apr 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Use a smartphone as personal or computer terminals enabled by the municipality of Milpa Alta or educational services.
- Be able to understand the nature, purpose and methodology of the study.
- Accept participation in the study and check the corresponding box in the app to verify that the informed consent has been expressly given.
Who cannot join
- Subject deprived of liberty (by judicial or administrative decision)
- Subject protected by law (guardianship or conservatorship)
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Alcaldía Milpa Alta. Ciudad de México
Mexico City, 12000
Pavel Arenas Castañeda, +52-5586148610, arenaspavel@gmail.com
Enrique Baca-García, Dr
About this study
Official title: 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.
- Conditions
- Suicidal Ideation, Depression, Depressive Disorder, Anxiety, Alcohol Abuse, Drug Abuse
- Being tested
- Self-administered evaluation questionnaire
- Keywords
- Mass Screening, Health Surveys, Mental Health, Suicidal Ideation
- Medical subject headings
- Suicidal Ideation, Depression, Depressive Disorder, Anxiety Disorders, Alcoholism, Substance-Related Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered evaluation questionnaireOther
Smartphone app with MeMind questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Milpa Alta inhabitants | Population among 15 and 70 years old Receives: Other: Self-administered evaluation questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 Day
Secondary outcomes (4)
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.
Measured: 1 Day
Anxiety
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.
Measured: 1 Day
Drug Utilization
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.
Measured: 1 Day
Alcohol Drinking
Participants will be asked to complete a questionnaire regarding possible symptoms related to alcohol abuse.
Alcohol Use Disorders Identification Test (AUDIT-C)
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start26 Aug 2019
- Primary completion23 Jan 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 150,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Mexico, Milpa Alta Municipalty, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado, Centro Interdisciplinario de Ciencias de la Salud, Mexico, Educational Institutions of Milpa Alta
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067063
- Sponsor's protocol ID
- SmartMexSurvey1
- Acronym
- Smart-screen
- Status last verified
- Jul 2020
- First submitted
- 22 Aug 2019
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available for researchers upon request
Publications
Arenas-Castaneda PE, Aroca Bisquert F, Martinez-Nicolas I, Castillo Espindola LA, Barahona I, Maya-Hernandez C, Lavana Hernandez MM, Manrique Miron PC, Alvarado Barrera DG, Trevino Aguilar E, Barrios Nunez A, De Jesus Carlos G, Vildosola Garces A, Flores Mercado J, Barrigon ML, Artes A, de Leon S, Molina-Pizarro CA, Rosado Franco A, Perez-Rodriguez M, Courtet P, Martinez-Ales G, Baca-Garcia E. Universal mental health screening with a focus on suicidal behaviour using smartphones in a Mexican rural community: protocol for the SMART-SCREEN population-based survey. BMJ Open. 2020 Jul 19;10(7):e035041. doi: 10.1136/bmjopen-2019-035041.
PubMed 32690505
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Massive Mental Health Screening Using Smartphone in Milpa Alta Community, Mexico.
- ClinicalTrials.gov ID
- NCT04067063
- Acronym / sponsor ID
- Smart-screen / SmartMexSurvey1
- Conditions
- Suicidal Ideation, Depression, Depressive Disorder, Anxiety, Alcohol Abuse, Drug Abuse
- Keywords
- Mass Screening, Health Surveys, Mental Health, Suicidal Ideation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150,000 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Mexico, Milpa Alta Municipalty, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado, Centro Interdisciplinario de Ciencias de la Salud, Mexico, Educational Institutions of Milpa Alta
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 23 Jan 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 26 Aug 2019 (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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Milpa Alta inhabitants | – | Other: Self-administered evaluation questionnairePopulation among 15 and 70 years old |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Use a smartphone as personal or computer terminals enabled by the municipality of Milpa Alta or educational services.
- Be able to understand the nature, purpose and methodology of the study.
- Accept participation in the study and check the corresponding box in the app to verify that the informed consent has been expressly given.
Key exclusion criteria (2 listed)
- Subject deprived of liberty (by judicial or administrative decision)
- Subject protected by law (guardianship or conservatorship)
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 |
|---|---|---|
| Self-administered evaluation questionnaireSmartphone app with MeMind questionnaires | Other | Milpa Alta inhabitants |
Primary outcome
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).
4 secondary outcomes
Depression
Time frame: 1 Day
Anxiety
Time frame: 1 Day
Drug Utilization
Time frame: 1 Day
Alcohol Drinking
Time frame: 1 Day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Derived from this study: PubMed 32690505Arenas-Castaneda PE, Aroca Bisquert F, Martinez-Nicolas I, Castillo Espindola LA, Barahona I, Maya-Hernandez C, Lavana Hernandez MM, Manrique Miron PC, Alvarado Barrera DG, Trevino Aguilar E, Barrios Nunez A, De Jesus Carlos G, Vildosola Garces A, Flores Mercado J, Barrigon ML, Artes A, de Leon S, Molina-Pizarro CA, Rosado Franco A, Perez-Rodriguez M, Courtet P, Martinez-Ales G, Baca-Garcia E. Universal mental health screening with a focus on suicidal behaviour using smartphones in a Mexican rural community: protocol for the SMART-SCREEN population-based survey. BMJ Open. 2020 Jul 19;10(7):e035041. doi: 10.1136/bmjopen-2019-035041.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be available for researchers upon request
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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.
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 Suicidal Ideation and Depression, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicidal ideation (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04067063, which also lists 1 linked publication.
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 7 Jul 2020.