Personal History of a Recent Suicidal CrisisSmartCriseSNCT03720730
SmartCriseS - Smartphone Survey of Suicidal Risk
A study testing EMA in people with Personal History of a Recent Suicidal Crisis and Suicidal Ideation, run by University Hospital, Montpellier at 2 sites in 2 countries.
Trial summary
Sleep and appetite disorders as well as social exclusion, have been linked to the emergence of suicidal ideation (SI) and suicide attempts.This study aims to evaluate the relationship between those factors and suicidal ideation and behaviour. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Personal History of a Recent Suicidal Crisis, Suicidal Ideation, Suicidal Behaviour
- What is being tested?
- EMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,044 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Nov 2018to 13 Apr 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be at least 18 years old
- To use a smartphone as a personal phone
- To have consulted in the context of a suicidal crisis within the last 7 days
- To be able to understand the nature, purpose and methodoly of the study.
- To be in a minimal treatment phase (according to the clinician's judgment).
- To accept participating to the study and the 6 months follow-up and to have signed the informed consent
Who cannot join
- Refusal of participation
- Subject protected by law (guardianship)
- Deprived of liberty Subject (by judicial or administrative decision)
- Diagnosis of a current hypomanic, manic or mixed episode, or a diagnosis of schizoaffective disorder or schizophrenia.
- No affiliation to the social safety system
- 65 years old patients and older with an MMSE score < 24 at baseline
Trial locations and contacts
2 sites in 2 countries.
Enrique Baca-Garcia, MD PhD contact
2 sites in 2 countries
France1 site, 1 recruiting
- Recruiting
CHU Montpellier
Montpellier, 34295
Catherine Genty, MD, + 33 4 67 99 61 45 75, c-genty@chu-montpellier.fr
Spain1 site, 1 recruiting
- Recruiting
Fundacion Jimenez Diaz Hospital
Madrid, 28040
Maria Barrigon, MD PhD, 00 34 915 41 72 67, luisa.barrigon@fjd.es
About this study
Official title: Sleep and Appetite Measures as Suicidal Risk Factors in a French- Spanish Cohort of Suicidal Patients.
Sleep and appetite disorders as well as social exclusion, have been linked to the emergence of suicidal ideation (SI) and suicide attempts.This study aims to evaluate the relationship between those factors and suicidal ideation and behaviour. To assess those factors an ecological momentary assessment (EMA) desing will be used.
EMA will be carried out using 2 applications integrated into the smartphone of participants (Android or iOS), one to make an explicit data collection with questions and another one for the implicit collection of data from mobile sensors.
Read more
1044 suicide attempters will be included in three sites and followed for 6 months. Participants will be evaluated at inclusion and at the end of follow-up. The hypothesis is that sleep, appetite and social exclusion factors collected with the smartphone application will be linked to the intensity of death wish, suicidal ideations and suicidal attempts.
An auxiliary study will also be led with 300 patients carrying an actimeter for the 30 first days after inclusion. This will help collecting more accurate data on various sleep parameters.
Read the detailed description
The proposed study will use ecological momentary assessment (EMA) via smartphone applications (apps) and wearable trackers to examine the relationship between suicidality (wish to die, suicidal ideation and suicide attempt) and changes in sleep quality and disturbed appetite. These behavioral markers, if the hypothesis is proven true, could help predict increased suicidal risk in real-time within a vulnerable population across different cultures.
The study aims to: (1) Establish the extent to which quality of sleep is related to suicide ideation and suicide attempts; (2) Establish the extent to which change in appetite is related to suicide ideation and suicide attempts; (3) Determine the emotional impact of the app when suicidality is assessed; (4) Clarify the timeline of the relationship between sleep disturbances and suicidal behavior; (5) Develop personalized algorithms based on EMA protocol and motor activity markers or "signatures" to assess the risk of suicide attempts.
The hypothesis is that variations in sleep quality will correlate with increased wish to die, suicide ideation and suicide attempts. It is expected that a decrease in sleep quality will be a suicide risk marker especially among young individuals.
This prospective cross-national study will use the infrastructure of an existing network (WORECA). Woreca has defined a common protocol of suicide assessment, data sharing and analysis strategy.
1044 suicide attempters will be included and followed for 6 months. Each participant will be assessed using an EMA protocol via two smartphone apps: (1) One app will ask everyday questions following a dynamic protocol to assess quality of sleep, appetite, suicidal ideation and psychopathology; (2) the other app will record activity using smartphone sensors. Additionally, 300 participants (150 in France and 150 in Spain) will have their sleep phases and other physiological changes during sleep monitored with a wearable armband. Study outcomes include wish to live, wish to die, suicidal ideation, and suicide attempt during the follow-up period.
A multi-level logit regression analysis will be used to account for multiple observations per individual, to identify individual-level (sleep, appetite, socio-demographic, clinical data, treatment data) and site-level characteristics associated with death desire, suicidal ideation or suicide attempt (aim 1 and 2). Hazards models will also be used to relate covariate characteristics (sleep, appetite, sociodemographic, clinical data, treatment data) with time to suicide reattempt during the follow-up period (aim 1 and 2). Data mining (machine learning) techniques will be used to examine risk factors, patterns of illness evolution (aim 3 and 4) and patient stratification by level of suicidal risk (aim 5).
Identifying surrogate markers of suicidality related with physiological functions, which carry less or no stigma for the patients and are easier to report, or have a lower reporting threshold is an essential task. These markers would allow to predict in real-time an increase in suicidal risk within a vulnerable population and ultimately help to prevent and even personalize treatment.Suicidal behaviours, including suicidal ideation, are preventable but to be efficient, prevention needs to rely on the identication of specific risk factors.
- Being tested
- EMA
- Keywords
- Suicidal crisis, Suicidal behaviour, Prevention, Smartphone application, Ecological momentary assessment, Psychiatry, Follow-up
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMAOther
The mobile application (EMA) combines an explicit data collection with an implicit one.
For the explicit data collection with Memind application, patients will have to answer specific questionnaires about sleep, appetite and social factors. Some of the questions will be asked on regular basis, at the same time everyday, while others will be asked randomly during the day (between 9 a.m and 9 p.m).
The implicit data collecting will be carried out using smartphone sensors (application eB2).
| Study group | Role | What they receive |
|---|---|---|
| Study participants | Experimental | Patients with a recent history of suicidal crisis (within the last 7 days) will use a smartphone application to evaluate sleep, appetite and social parameters. Receives: Other: EMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of suicidal event assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Evaluate the occurrence of a suicidal event with the C-SSRS. The questionnaire includes four subscales. The suicidal ideation severity subscale ranges from 1 to 5 (with higher number indicating more severe ideation). The intensity of ideation subscale includes 5 questions each one ranging from 1 to 5 (with higher number indicating more intense ideation). The suicidal behavior subscale includes 4 yes/no questions. The suicidal behavior lethality subscale inquires about the level of actual or potential medical damage.
Measured: 6 months
Secondary outcomes (10)
Evaluation of insomnia assessed by ecological momentary assessment (EMA)
Evaluate insomnia with the Insomnia Severity Index (ISI) score using EMA questions. The ISI score ranges from 0 to 27 (higher number indicating more severe insomnia).
Measured: 6 months
Evaluation of insomnia assessed by Insomnia Severity Index (ISI)
Evaluate insomnia with the ISI score. The ISI score ranges from 0 to 27 (higher number indicating more severe insomnia).
Measured: 6 months
Evaluation of appetite assessed by ecological momentary assessment (EMA)
Evaluate appetite using the Council of Nutrition Appetite Questionnaire (CNAQ) score with EMA questions. The CNAQ score ranges from 8 to 40 (a score of less than 28 is cause for concern, with lower number indicating greater risk).
Measured: 6 months
Evaluation of sensibility to social exclusion assessed by ecological momentary assessment (EMA)
Evaluate social sensibility with EMA questions based on the Perceived Social Support and Interpersonal Needs Questionnaire
Measured: 6 months
Evaluation of suicidal ideation intensity assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Evaluate suicidal ideation intensity with the C-SSRS. The severity of suicidal ideation subscale ranges from 1 to 5 (with higher number indicating more severe ideation). The intensity of ideation subscale includes 5 questions each ranging from 1 to 5 (with higher number indicating more intense ideation). The suicidal behavior subscale includes 4 yes/no questions. The suicidal behavior lethality subscale inquires about the level of actual or potential medical damage.
Measured: 6 months
Evaluation of the intensity of death wish assessed by ecological momentary assessment (EMA)
Evaluate death wish intensity with analogical scales
Measured: 6 months
Evaluation of suicide attempts severity assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Evaluate suicide attempts severity with the C-SSRS. The severity of suicidal ideation subscale ranges from 1 to 5 (with higher number indicating more severe ideation). The intensity of ideation subscale includes 5 questions each ranging from 1 to 5 (with higher number indicating more intense ideation). The suicidal behavior subscale includes 4 yes/no questions. The suicidal behavior lethality subscale inquires about the level of actual or potential medical damage.
Measured: 6 months
Evaluation of sleep duration assessed by Pittsburgh Sleep Quality Index (PSQI)
Evaluate sleep duration with one item from the PSQI (hours of night sleep during the past week) using EMA
Measured: 6 months
Evaluation of sleep duration assessed by Pittsburgh Sleep Quality Index (PSQI)
Evaluate sleep duration with the PSQI at the end of follow-up. The PSQI score ranges from 0 to 21 (lower score indicating healthier sleep quality)
Measured: 6 months
Evaluation of physical activity by eB2
Evaluate physical activity with smartphone sensors (eB2).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start13 Nov 2018
- Primary completion13 Jan 2026 (estimated)
- Study completion13 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Personal History of a Recent Suicidal CrisisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,044 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nīmes, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, INSERM U1061 Neuropsychiatry Montpellier, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720730
- Sponsor's protocol ID
- UF 9821
- Acronym
- SmartCriseS
- Status last verified
- Dec 2021
- First submitted
- 24 Oct 2018
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
PubMed 33884617Berrouiguet S, Barrigon ML, Castroman JL, Courtet P, Artes-Rodriguez A, Baca-Garcia E. Combining mobile-health (mHealth) and artificial intelligence (AI) methods to avoid suicide attempts: the Smartcrises study protocol. BMC Psychiatry. 2019 Sep 7;19(1):277. doi: 10.1186/s12888-019-2260-y.
PubMed 31493783
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Appetite Measures as Suicidal Risk Factors in a French- Spanish Cohort of Suicidal Patients.
- ClinicalTrials.gov ID
- NCT03720730
- Acronym / sponsor ID
- SmartCriseS / UF 9821
- Keywords
- Suicidal crisis, Suicidal behaviour, Prevention, Smartphone application, Ecological momentary assessment, Psychiatry, Follow-up
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,044 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nīmes, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, INSERM U1061 Neuropsychiatry Montpellier, France
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 13 Jan 2026 (estimated)
- Study completion
- 13 Apr 2026 (estimated)
- First posted
- 25 Oct 2018 (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.
Sleep and appetite disorders as well as social exclusion, have been linked to the emergence of suicidal ideation (SI) and suicide attempts.This study aims to evaluate the relationship between those factors and suicidal ideation and behaviour. To assess those factors an ecological momentary assessment (EMA) desing will be used.
EMA will be carried out using 2 applications integrated into the smartphone of participants (Android or iOS), one to make an explicit data collection with questions and another one for the implicit collection of data from mobile sensors.
1044 suicide attempters will be included in three sites and followed for 6 months. Participants will be evaluated at inclusion and at the end of follow-up. The hypothesis is that sleep, appetite and social exclusion factors collected with the smartphone application will be linked to the intensity of death wish, suicidal ideations and suicidal attempts.
An auxiliary study will also be led with 300 patients carrying an actimeter for the 30 first days after inclusion. This will help collecting more accurate data on various sleep parameters.
Detailed description
The proposed study will use ecological momentary assessment (EMA) via smartphone applications (apps) and wearable trackers to examine the relationship between suicidality (wish to die, suicidal ideation and suicide attempt) and changes in sleep quality and disturbed appetite. These behavioral markers, if the hypothesis is proven true, could help predict increased suicidal risk in real-time within a vulnerable population across different cultures.
The study aims to: (1) Establish the extent to which quality of sleep is related to suicide ideation and suicide attempts; (2) Establish the extent to which change in appetite is related to suicide ideation and suicide attempts; (3) Determine the emotional impact of the app when suicidality is assessed; (4) Clarify the timeline of the relationship between sleep disturbances and suicidal behavior; (5) Develop personalized algorithms based on EMA protocol and motor activity markers or "signatures" to assess the risk of suicide attempts.
The hypothesis is that variations in sleep quality will correlate with increased wish to die, suicide ideation and suicide attempts. It is expected that a decrease in sleep quality will be a suicide risk marker especially among young individuals.
This prospective cross-national study will use the infrastructure of an existing network (WORECA). Woreca has defined a common protocol of suicide assessment, data sharing and analysis strategy.
1044 suicide attempters will be included and followed for 6 months. Each participant will be assessed using an EMA protocol via two smartphone apps: (1) One app will ask everyday questions following a dynamic protocol to assess quality of sleep, appetite, suicidal ideation and psychopathology; (2) the other app will record activity using smartphone sensors. Additionally, 300 participants (150 in France and 150 in Spain) will have their sleep phases and other physiological changes during sleep monitored with a wearable armband. Study outcomes include wish to live, wish to die, suicidal ideation, and suicide attempt during the follow-up period.
A multi-level logit regression analysis will be used to account for multiple observations per individual, to identify individual-level (sleep, appetite, socio-demographic, clinical data, treatment data) and site-level characteristics associated with death desire, suicidal ideation or suicide attempt (aim 1 and 2). Hazards models will also be used to relate covariate characteristics (sleep, appetite, sociodemographic, clinical data, treatment data) with time to suicide reattempt during the follow-up period (aim 1 and 2). Data mining (machine learning) techniques will be used to examine risk factors, patterns of illness evolution (aim 3 and 4) and patient stratification by level of suicidal risk (aim 5).
Identifying surrogate markers of suicidality related with physiological functions, which carry less or no stigma for the patients and are easier to report, or have a lower reporting threshold is an essential task. These markers would allow to predict in real-time an increase in suicidal risk within a vulnerable population and ultimately help to prevent and even personalize treatment.Suicidal behaviours, including suicidal ideation, are preventable but to be efficient, prevention needs to rely on the identication of specific risk factors.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study participants | Experimental | Other: EMAPatients with a recent history of suicidal crisis (within the last 7 days) will use a smartphone application to evaluate sleep, appetite and social parameters. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- To be at least 18 years old
- To use a smartphone as a personal phone
- To have consulted in the context of a suicidal crisis within the last 7 days
- To be able to understand the nature, purpose and methodoly of the study.
- To be in a minimal treatment phase (according to the clinician's judgment).
Key exclusion criteria (6 listed)
- Refusal of participation
- Subject protected by law (guardianship)
- Deprived of liberty Subject (by judicial or administrative decision)
- Diagnosis of a current hypomanic, manic or mixed episode, or a diagnosis of schizoaffective disorder or schizophrenia.
- No affiliation to the social safety system
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 |
|---|---|---|
| EMAThe mobile application (EMA) combines an explicit data collection with an implicit one. For the explicit data collection with Memind application, patients will have to answer specific questionnaires about sleep, appetite and social factors. Some of the questions will be asked on regular basis, at the same time everyday, while others will be asked randomly during the day (between 9 a.m and 9 p.m). The implicit data collecting will be carried out using smartphone sensors (application eB2). | Other | Study participants |
Primary outcome
Occurrence of suicidal event assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 6 months
Evaluate the occurrence of a suicidal event with the C-SSRS. The questionnaire includes four subscales. The suicidal ideation severity subscale ranges from 1 to 5 (with higher number indicating more severe ideation). The intensity of ideation subscale includes 5 questions each one ranging from 1 to 5 (with higher number indicating more intense ideation). The suicidal behavior subscale includes 4 yes/no questions. The suicidal behavior lethality subscale inquires about the level of actual or potential medical damage.
10 secondary outcomes
Evaluation of insomnia assessed by ecological momentary assessment (EMA)
Time frame: 6 months
Evaluation of insomnia assessed by Insomnia Severity Index (ISI)
Time frame: 6 months
Evaluation of appetite assessed by ecological momentary assessment (EMA)
Time frame: 6 months
Evaluation of sensibility to social exclusion assessed by ecological momentary assessment (EMA)
Time frame: 6 months
Evaluation of suicidal ideation intensity assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 6 months
Evaluation of the intensity of death wish assessed by ecological momentary assessment (EMA)
Time frame: 6 months
Evaluation of suicide attempts severity assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 6 months
Evaluation of sleep duration assessed by Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 months
Evaluation of sleep duration assessed by Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 months
Evaluation of physical activity by eB2
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Derived from this study: PubMed 33884617Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
- Derived from this study: PubMed 31493783Berrouiguet S, Barrigon ML, Castroman JL, Courtet P, Artes-Rodriguez A, Baca-Garcia E. Combining mobile-health (mHealth) and artificial intelligence (AI) methods to avoid suicide attempts: the Smartcrises study protocol. BMC Psychiatry. 2019 Sep 7;19(1):277. doi: 10.1186/s12888-019-2260-y.
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.
Enrique Baca-Garcia, MD PhD contact
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMA in people with Personal History of a Recent Suicidal Crisis and Suicidal Ideation, run by University Hospital, Montpellier at 2 sites in 2 countries.
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 6 inclusion and 6 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 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Spain. 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?
Contact Jorge Lopez Castroman, MD PhD (+33 4 66 68 34 26, Jorge.lopezcastroman@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of suicidal event assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (time frame: 6 months). 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 NCT03720730, which also lists 2 linked publications.
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 Dec 2021.