Suicide and DepressionPRINTEMPSNCT03565562

Preventing Psychological Distress and Suicidal Behaviours: a Web-based and Mobile Suicide Prevention Intervention in the General Population

A study testing Promotion of the e-health tool by local authorities and Promotion of the e-health tool by local authorities and GPs in people with Suicide and Depression and Psychological Distress, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Suicide and Depression, Psychological Distress, Anxiety Disorders
What is being tested?: Promotion of the e-health tool by local authorities and Promotion of the e-health tool by local authorities and GPs
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100,000 participants
Where: 1 siteFrance
Study dates: 1 Apr 2018to 31 Mar 2020
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

>18 years
living in one of the 42 french local authority participating to the trial
volunteer
access to internet (smartphone/tablet/computer)

Who cannot join

<18 years

Trial locations and contacts

1 site in 1 country.

France1 site

Faculté de Médecine Paris Diderot Paris 7
Paris, 75010

Other trials in France

About this study

An interventional research study will be undertaken to assess the effectiveness of the promotion at the local level of an e-health tool for suicide and psychological distress prevention (the StopBlues application and website). This trial is a cluster-randomized, parallel group, controlled intervention study with local authorities as the unit of randomization. Local authorities will be randomly assigned to one of the following three arms: local authorities not promoting the e-health tool (control group); local authorities promoting the e-health tool without general practitioners (GPs) involvement; local authorities promoting the e-health tool including GPs' waiting room. The trial will last 24 months and after a 12-month post-randomization period, local authorities from the control group will be allowed for a further 12-month period to launch their promotional campaign supported by the research team through regular contacts and additional technical and financial resources (intensively sustained promotion). This will facilitate the recruitment of clusters as well as their adherence to the intervention during the first 12-month period. The main criterion will be the number of suicidal acts at nine months. Data will be collected both at the local authority level and at the individual e-health tool user level.

Read the detailed description

Context France is one of the Western European countries most affected by suicide, which is associated with a high societal cost. Recently, a European project aiming to develop best practice for suicide prevention has recommended the development of web-based interventions and the French national plan for actions against suicide has supported the development of reference websites for suicide prevention. However, web-based interventions should be associated with effective promotional efforts to ensure awareness but also to improve receptiveness among and around those who could benefit from such a resource. Previous work has shown that local authorities are appropriate actors for promoting prevention measures against suicide and that 20% of individuals attempting suicide visit their GP the day before their attempt.
Research objectives The primary objective of our trial is to assess the effectiveness of the tailored promotion at local level of an e-health tool and to compare the effectiveness at 12 months of two types of local promotion (with or without involving GPs' waiting room) on suicidal acts. The secondary objectives are to assess the cost-effectiveness and to run a budgetary impact analysis of the intervention. Moreover, our secondary objectives are to assess the effectiveness of the promotion on the intensity of utilization of StopBlues by the three types of users (living in a city without promotion or with promotion or reinforced promotion), on their help-seeking behavior, on their implementation of supportive activities into their daily life and on the evolution of users level of psychological impairment. An additional form of promotion (intensively sustained promotion) will be implemented after 12 months in the control group and evaluated using the same primary outcome measure. In parallel, the long-term effectiveness of the two main types of local promotion (with or without a passive involvement of GPs through their waiting room) will also be assessed.
Methodology The detailed content of the e-health tool and the promotional tools to be made available to local authorities and GPs was determined through literature reviews and focus groups with experts and users.

A cluster-randomized, parallel group, controlled intervention study with local authorities as the unit of randomization will be set up. Local authorities can either be cities or a grouping of cities ("communauté de communes"), based on the local health governance of each area. If several adjacent local authorities volunteer individually to participate in the trial, they will be considered as a unique local authority. Volunteer local authorities will be randomly assigned to one of the following three arms: those not promoting the e-health tool (control group); those promoting the e-health tool without involving GPs' waiting rooms; those promoting the e-health tool involving GPs' waiting rooms.

The trial will last 24 months and local authorities will be able to switch arm if they so wish after 12 months and launch an 'intensively sustained promotion'. This will facilitate recruitment of local authorities as well as their adherence to the intervention. Data will be collected both at the local authority level and at the individual user level.

Expected results The investigators anticipate that the promotion of the e-health intervention will lead to a greater difference in the number of suicidal acts in the local authorities where it is implemented over the trial period. Furthermore, it should also result in a higher reduction of psychological distress and in an increased intensity and length of use of the e-health tool. The promotion may also lead members of the population with moderate level of psychological distress, who may not otherwise be seeking help, to access the e-health tool and should also facilitate help-seeking behaviors and implementation of supportive activities into their daily life. The intensively sustained promotion should lead to higher rates of connexion and by then to a higher reduction of psychological distress and in an increased intensity and length of use of the e-health tool.

Moreover, this project will give information on the relevance of our promotion model for primary prevention of psychological distress. Indeed, if the findings are satisfactory, this model and the formalized networks for promotion within local authorities may facilitate development of additional primary prevention measures both for mental disorders and other health issues.

Conditions: Suicide and Depression, Psychological Distress, Anxiety Disorders, Local Authorities Promotion
Being tested: Promotion of the e-health tool by local authorities, Promotion of the e-health tool by local authorities and GPs
Keywords: Health promotion, Local authorities involvement, Suicide and attempted suicide, Primary prevention, Psychological Distress
Medical subject headings: Suicide, Depression, Anxiety Disorders, Suicide, Attempted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Promotion of the e-health tool by local authoritiesOther
Also called StopBlues
Local authorities participating in the trial will select a referent person who will be in charge of the implementation and follow-up of the promotion. A promotion toolkit with recommendations, posters, web banners, leaflets and ready-made messages and press articles will be provided to the local authorities.
Promotion of the e-health tool by local authorities and GPsOther
Also called StopBlues
In those local authorities, GPs will participate passively to the promotion of the e-health tool, by providing posters and leaflets in their waiting rooms.

Study groups in NCT03565562
Study group	Role	What they receive
Control group	No intervention	Local authorities allocated to this group won't implement any promotion of the e-health tool for the 12 first months. Free access to StopBlues.
Group experimental 1 promotion	Active comparator	Local authorities allocated to this group will have to implement the promotion of the e-health tool: the promotion at the local authority level. They will promote the e-health tool using their usual communication methods (local newspapers, local website, bulletin and billboards, posters in the local shops and in the bus stops…). Free access to StopBlues. Receives: Other: Promotion of the e-health tool by local authorities
Group experimental 2 promotion	Active comparator	Local authorities allocated to this group will have to implement promotion of the e-health tool: the promotion at local authority and GPs' waiting room level. Local authorities will promote the e-health tool using their usual communication methods (local newspapers, local website, bulletin and billboards, posters in the local shops and in the bus stops...). (similarly to group experimental1) as well as leaflets and posters in GPs' waiting room. Free access to StopBlues. Receives: Other: Promotion of the e-health tool by local authorities; Other: Promotion of the e-health tool by local authorities and GPs

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of suicides - Short term
The number of completed suicides will be extracted from the database of the Epidemiology center on medical causes of deaths (CépiDc) for each local authority participating.
Measured: At month 9
Number of suicide attempts - Short term
The number of attempted suicides will be extracted from the national database of public and private hospital admissions (PMSI-MCO) and the national emergency database (Oscour).
Measured: At month 9

Secondary outcomes (16)

Number of suicides - Long term
The number of completed suicides will be extracted from the database of the Epidemiology center on medical causes of deaths (CépiDc) for each local authority participating.
Measured: At the end of the trial (month 18)
Number of suicide attempts - Long term
The number of attempted suicides will be extracted from the national database of public and private hospital admissions (PMSI-MCO) and the national emergency database (Oscour).
Measured: At the end of the trial (month 18)
Costs
Fixed costs for the development of the intervention including promotions tools, semi-fixed costs for the implementation of the program by local authorities and GPs, costs of suicidal acts.
Measured: At 9 months and at the end of the trial (month 18)
Level of health-related quality of life and associated utility of StopBlues users
Collected through self-assessment at the user level with the quality of life questionnaire Short Form-12 (SF-12).
Measured: At registration, and 1, 2, 3, 6, 12 and 18 months after
Level of psychological pain of StopBlues users
Collected through self-assessment at the user level with the 12-item General Health Questionnaire (GHQ-12).
Measured: At registration, and then at 1, 2, 3, 6, 12 and 18 months
Level of depression of StopBlues users
Collected through self-assessment at the user level with the Patient Health Questionnaire (PHQ-9)
Measured: At registration, and then at 1, 2, 3, 6, 12 and 18 months
Level of anxiety of StopBlues users
Collected through self-assessment at the user level with the General Anxiety Disorder questionnaire (GAD-7).
Measured: At registration, and then at 1, 2, 3, 6, 12 and 18 months
Level of suicidal risk of StopBlues users
Collected through self-assessment at the user level with the 6 questions on the suicidal risk of the Mini International Neuropsychiatric Interview-Simplified (MINI-S). The MINI-S is not available at registration, it will be triggered when results to GHQ-12, PHQ-9 and/or GAD-7 are considered showing a suicidal risk for the user.
Measured: At first filling and 1, 2, 3, 6, 12 and 18 months after
Help-seeking behaviors and implementation of supportive activities into daily life of StopBlues users
Collected through self-assessment at the user level with an ad hoc questionnaire adapted from the general health-seeking questionnaire (GHSQ).
Measured: At registration, and 1, 2, 3, 6, 12 and 18 months after
Level of depression (for StopBlues users coming for a relative)
Collected at the user level with the Montgomery-Asberg Depression Scale (MADRS). It has 10 questions, quoted from 0 to 6.
Measured: At registration
Intention to seek help of StopBlues users
French traduction of the first question of the General Help-Seeking Questionnaire -Original Version (GHSQ).
Measured: At registration for users coming for a relative, and at registration and 1, 2, 3, 6, 12 and 18 months after for users coming for themselves
Intensity of the participation to the application and website
Number of downloads and connections for each zip codes of local authorities included in the trial.
Measured: At month 9 and 18 (end of the trial)
Length of use to the application and website
Time-lapse between the inscription and the last connection to the application or website.
Measured: At month 9 and 18 (end of the trial)
Proportion of StopBlues users who came to know the e-health tool through the different communication channels
Collected at the user level with a specific question: "How did you get to know about the StopBlues program?" .
1/ By public display 2/ In public places (employment center, library ...) 3/ On my city website 4/ By the press 5/ Through social networks 6/ At merchants 7/ At my pharmacist 8/ At my GP 9/ At another health professional (physiotherapist, medical specialist ...) 10/Through relationships (friends, families, neighbors ...) 11/ Other
Measured: At registration
Proportion of StopBlues users who came for a relative
The proportion of users who subscribed for a relative and not for themselves.
Measured: At registration
StopBlues users with a safety plan
The proportion of users who filled up a safety plan.
Measured: At month 9 and 18 (end of the trial)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201831 Mar 2020

First posted21 Jun 2018
Study start1 Apr 2018
Primary completion31 Dec 2018
Study completion31 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (25)Papers the sponsor has linked to this study.
Other trials for Suicide and DepressionStudies of the same condition, open and under way.
More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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: Randomised
Intervention model: Parallel groups
Model description: cluster randomized, open parallel groups , controlled intervention study
Masking: None (open label)
Enrolment: 100,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03565562
Sponsor's protocol ID: C 15-45
Acronym: PRINTEMPS
Status last verified: Dec 2019
First submitted: 20 Apr 2018
Last updated: 18 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Bertolote J, Fleischmann A. A global perspective on the magnitude of suicide mortality. The Oxford Textbook of Suicidology and Suicide Prevention: A Global Perspective. Oxford: Oxford University Press. Wasserman D., Wasserman C.; 2009. p. 91 98.
Marie-Claude Mouquet, Bellamy V. Suicides et tentatives de suicide en France. Etude et Résultats. Mai 2006;(488).
O'Dea D, Tucker S. The cost of suicide to society. Wellington: Ministry of Health. 2005.
Kennelly B. The economic cost of suicide in Ireland. Crisis. 2007;28(2):89-94. doi: 10.1027/0227-5910.28.2.89.
PubMed 17722690
du Roscoat E, Beck F. Efficient interventions on suicide prevention: a literature review. Rev Epidemiol Sante Publique. 2013 Aug;61(4):363-74. doi: 10.1016/j.respe.2013.01.099. Epub 2013 Jul 10.
PubMed 23849295
Warnet S. [New national program for the prevention of suicide]. Rev Infirm. 2011 Nov;(175):4. No abstract available. French.
PubMed 22206200
Ministère des Affaires Sociales et de la Santé. Décret n° 2013-809 du 9 septembre 2013 portant création de l'Observatoire National du Suicide. 2013
Atkinson NL, Saperstein SL, Pleis J. Using the internet for health-related activities: findings from a national probability sample. J Med Internet Res. 2009 Feb 20;11(1):e4. doi: 10.2196/jmir.1035.
PubMed 19275980
Dickerson S, Reinhart AM, Feeley TH, Bidani R, Rich E, Garg VK, Hershey CO. Patient Internet use for health information at three urban primary care clinics. J Am Med Inform Assoc. 2004 Nov-Dec;11(6):499-504. doi: 10.1197/jamia.M1460. Epub 2004 Aug 6.
PubMed 15298993
Haga SM, Drozd F, Brendryen H, Slinning K. Mamma mia: a feasibility study of a web-based intervention to reduce the risk of postpartum depression and enhance subjective well-being. JMIR Res Protoc. 2013 Aug 12;2(2):e29. doi: 10.2196/resprot.2659.
PubMed 23939459
Monshat K, Vella-Brodrick D, Burns J, Herrman H. Mental health promotion in the Internet age: a consultation with Australian young people to inform the design of an online mindfulness training programme. Health Promot Int. 2012 Jun;27(2):177-86. doi: 10.1093/heapro/dar017. Epub 2011 Mar 11.
PubMed 21398335
Allen J, Mohatt G, Fok CC, Henry D; People Awakening Team. Suicide prevention as a community development process: understanding circumpolar youth suicide prevention through community level outcomes. Int J Circumpolar Health. 2009 Jun;68(3):274-91. doi: 10.3402/ijch.v68i3.18328.
PubMed 19705659
Bean G, Baber KM. Connect: an effective community-based youth suicide prevention program. Suicide Life Threat Behav. 2011 Feb;41(1):87-97. doi: 10.1111/j.1943-278X.2010.00006.x. Epub 2011 Jan 24.
PubMed 21309827
Ono Y, Sakai A, Otsuka K, Uda H, Oyama H, Ishizuka N, Awata S, Ishida Y, Iwasa H, Kamei Y, Motohashi Y, Nakamura J, Nishi N, Watanabe N, Yotsumoto T, Nakagawa A, Suzuki Y, Tajima M, Tanaka E, Sakai H, Yonemoto N. Effectiveness of a multimodal community intervention program to prevent suicide and suicide attempts: a quasi-experimental study. PLoS One. 2013 Oct 9;8(10):e74902. doi: 10.1371/journal.pone.0074902. eCollection 2013.
PubMed 24130673
Pearson A, Saini P, Da Cruz D, Miles C, While D, Swinson N, Williams A, Shaw J, Appleby L, Kapur N. Primary care contact prior to suicide in individuals with mental illness. Br J Gen Pract. 2009 Nov;59(568):825-32. doi: 10.3399/bjgp09X472881.
PubMed 19861027

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preventing Psychological Distress and Suicidal Behaviours: a Web-based and Mobile Suicide Prevention Intervention in the General Population
ClinicalTrials.gov ID: NCT03565562
Acronym / sponsor ID: PRINTEMPS / C 15-45
Conditions: Suicide and Depression, Psychological Distress, Anxiety Disorders, Local Authorities Promotion
Keywords: Health promotion, Local authorities involvement, Suicide and attempted suicide, Primary prevention, Psychological Distress
Study type: Interventional
Recruitment status: Completed
Enrolment: 100,000 participants (actual)
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, FranceOther government
Collaborators: National Agency of Public Health, Centre Collaborateur OMS pour la recherche et la formation en santé mentale, Institut de Recherche en Santé Publique, France, UMR INSERM 1246 - SPHERE MethodS in Patients-centered outcomes and HEalth ResEarch
Study start: 1 Apr 2018 (actual)
Primary completion: 31 Dec 2018 (actual)
Study completion: 31 Mar 2020 (actual)
First posted: 21 Jun 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.

Detailed description

Context France is one of the Western European countries most affected by suicide, which is associated with a high societal cost. Recently, a European project aiming to develop best practice for suicide prevention has recommended the development of web-based interventions and the French national plan for actions against suicide has supported the development of reference websites for suicide prevention. However, web-based interventions should be associated with effective promotional efforts to ensure awareness but also to improve receptiveness among and around those who could benefit from such a resource. Previous work has shown that local authorities are appropriate actors for promoting prevention measures against suicide and that 20% of individuals attempting suicide visit their GP the day before their attempt.
Research objectives The primary objective of our trial is to assess the effectiveness of the tailored promotion at local level of an e-health tool and to compare the effectiveness at 12 months of two types of local promotion (with or without involving GPs' waiting room) on suicidal acts. The secondary objectives are to assess the cost-effectiveness and to run a budgetary impact analysis of the intervention. Moreover, our secondary objectives are to assess the effectiveness of the promotion on the intensity of utilization of StopBlues by the three types of users (living in a city without promotion or with promotion or reinforced promotion), on their help-seeking behavior, on their implementation of supportive activities into their daily life and on the evolution of users level of psychological impairment. An additional form of promotion (intensively sustained promotion) will be implemented after 12 months in the control group and evaluated using the same primary outcome measure. In parallel, the long-term effectiveness of the two main types of local promotion (with or without a passive involvement of GPs through their waiting room) will also be assessed.
Methodology The detailed content of the e-health tool and the promotional tools to be made available to local authorities and GPs was determined through literature reviews and focus groups with experts and users.

Expected results The investigators anticipate that the promotion of the e-health intervention will lead to a greater difference in the number of suicidal acts in the local authorities where it is implemented over the trial period. Furthermore, it should also result in a higher reduction of psychological distress and in an increased intensity and length of use of the e-health tool. The promotion may also lead members of the population with moderate level of psychological distress, who may not otherwise be seeking help, to access the e-health tool and should also facilitate help-seeking behaviors and implementation of supportive activities into their daily life. The intensively sustained promotion should lead to higher rates of connexion and by then to a higher reduction of psychological distress and in an increased intensity and length of use of the e-health tool.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: cluster randomized, open parallel groups , controlled intervention study

Arm	Type	Receives
Control group	No intervention	–Local authorities allocated to this group won't implement any promotion of the e-health tool for the 12 first months. Free access to StopBlues.
Group experimental 1 promotion	Active comparator	Other: Promotion of the e-health tool by local authoritiesLocal authorities allocated to this group will have to implement the promotion of the e-health tool: the promotion at the local authority level. They will promote the e-health tool using their usual communication methods (local newspapers, local website, bulletin and billboards, posters in the local shops and in the bus stops…). Free access to StopBlues.
Group experimental 2 promotion	Active comparator	Other: Promotion of the e-health tool by local authorities, Other: Promotion of the e-health tool by local authorities and GPsLocal authorities allocated to this group will have to implement promotion of the e-health tool: the promotion at local authority and GPs' waiting room level. Local authorities will promote the e-health tool using their usual communication methods (local newspapers, local website, bulletin and billboards, posters in the local shops and in the bus stops...). (similarly to group experimental1) as well as leaflets and posters in GPs' waiting room. Free access to StopBlues.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

>18 years
living in one of the 42 french local authority participating to the trial
volunteer
access to internet (smartphone/tablet/computer)

Key exclusion criteria (1 listed)

<18 years

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
Promotion of the e-health tool by local authoritiesAlso: StopBluesLocal authorities participating in the trial will select a referent person who will be in charge of the implementation and follow-up of the promotion. A promotion toolkit with recommendations, posters, web banners, leaflets and ready-made messages and press articles will be provided to the local authorities.	Other	Group experimental 1 promotion, Group experimental 2 promotion
Promotion of the e-health tool by local authorities and GPsAlso: StopBluesIn those local authorities, GPs will participate passively to the promotion of the e-health tool, by providing posters and leaflets in their waiting rooms.	Other	Group experimental 2 promotion

Primary outcome

Number of suicides - Short term
Time frame: At month 9
The number of completed suicides will be extracted from the database of the Epidemiology center on medical causes of deaths (CépiDc) for each local authority participating.
Number of suicide attempts - Short term
Time frame: At month 9
The number of attempted suicides will be extracted from the national database of public and private hospital admissions (PMSI-MCO) and the national emergency database (Oscour).

16 secondary outcomes

Number of suicides - Long term
Time frame: At the end of the trial (month 18)
Number of suicide attempts - Long term
Time frame: At the end of the trial (month 18)
Costs
Time frame: At 9 months and at the end of the trial (month 18)
Level of health-related quality of life and associated utility of StopBlues users
Time frame: At registration, and 1, 2, 3, 6, 12 and 18 months after
Level of psychological pain of StopBlues users
Time frame: At registration, and then at 1, 2, 3, 6, 12 and 18 months
Level of depression of StopBlues users
Time frame: At registration, and then at 1, 2, 3, 6, 12 and 18 months
Level of anxiety of StopBlues users
Time frame: At registration, and then at 1, 2, 3, 6, 12 and 18 months
Level of suicidal risk of StopBlues users
Time frame: At first filling and 1, 2, 3, 6, 12 and 18 months after
Help-seeking behaviors and implementation of supportive activities into daily life of StopBlues users
Time frame: At registration, and 1, 2, 3, 6, 12 and 18 months after
Level of depression (for StopBlues users coming for a relative)
Time frame: At registration
Intention to seek help of StopBlues users
Time frame: At registration for users coming for a relative, and at registration and 1, 2, 3, 6, 12 and 18 months after for users coming for themselves
Intensity of the participation to the application and website
Time frame: At month 9 and 18 (end of the trial)
Length of use to the application and website
Time frame: At month 9 and 18 (end of the trial)
Proportion of StopBlues users who came to know the e-health tool through the different communication channels
Time frame: At registration
Proportion of StopBlues users who came for a relative
Time frame: At registration
StopBlues users with a safety plan
Time frame: At month 9 and 18 (end of the trial)

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 18 Feb 2026.
BackgroundBertolote J, Fleischmann A. A global perspective on the magnitude of suicide mortality. The Oxford Textbook of Suicidology and Suicide Prevention: A Global Perspective. Oxford: Oxford University Press. Wasserman D., Wasserman C.; 2009. p. 91 98.
BackgroundMarie-Claude Mouquet, Bellamy V. Suicides et tentatives de suicide en France. Etude et Résultats. Mai 2006;(488).
BackgroundO'Dea D, Tucker S. The cost of suicide to society. Wellington: Ministry of Health. 2005.
Background: PubMed 17722690Kennelly B. The economic cost of suicide in Ireland. Crisis. 2007;28(2):89-94. doi: 10.1027/0227-5910.28.2.89.
Background: PubMed 23849295du Roscoat E, Beck F. Efficient interventions on suicide prevention: a literature review. Rev Epidemiol Sante Publique. 2013 Aug;61(4):363-74. doi: 10.1016/j.respe.2013.01.099. Epub 2013 Jul 10.
Background: PubMed 22206200Warnet S. [New national program for the prevention of suicide]. Rev Infirm. 2011 Nov;(175):4. No abstract available. French.
BackgroundMinistère des Affaires Sociales et de la Santé. Décret n° 2013-809 du 9 septembre 2013 portant création de l'Observatoire National du Suicide. 2013
Background: PubMed 19275980Atkinson NL, Saperstein SL, Pleis J. Using the internet for health-related activities: findings from a national probability sample. J Med Internet Res. 2009 Feb 20;11(1):e4. doi: 10.2196/jmir.1035.
Background: PubMed 15298993Dickerson S, Reinhart AM, Feeley TH, Bidani R, Rich E, Garg VK, Hershey CO. Patient Internet use for health information at three urban primary care clinics. J Am Med Inform Assoc. 2004 Nov-Dec;11(6):499-504. doi: 10.1197/jamia.M1460. Epub 2004 Aug 6.
Background: PubMed 23939459Haga SM, Drozd F, Brendryen H, Slinning K. Mamma mia: a feasibility study of a web-based intervention to reduce the risk of postpartum depression and enhance subjective well-being. JMIR Res Protoc. 2013 Aug 12;2(2):e29. doi: 10.2196/resprot.2659.
Background: PubMed 21398335Monshat K, Vella-Brodrick D, Burns J, Herrman H. Mental health promotion in the Internet age: a consultation with Australian young people to inform the design of an online mindfulness training programme. Health Promot Int. 2012 Jun;27(2):177-86. doi: 10.1093/heapro/dar017. Epub 2011 Mar 11.
Background: PubMed 19705659Allen J, Mohatt G, Fok CC, Henry D; People Awakening Team. Suicide prevention as a community development process: understanding circumpolar youth suicide prevention through community level outcomes. Int J Circumpolar Health. 2009 Jun;68(3):274-91. doi: 10.3402/ijch.v68i3.18328.
Individual participant dataSharing planned: Undecided

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Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression
Depressive Disorder, Major Depressive Disorder, Suicidal Ideation
Active, not recruitingPhase 2
i-CBT and IV Ketamine for Suicidality in Treatment-Resistant Depression: A Randomized, Midazolam-Controlled Clinical Trial
Major Depressive Disorder, Suicide
RecruitingObservational study
Natural History of Depression, Bipolar Disorder and Suicide Risk
Behavioral Symptoms, Suicide

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.

Karine Chevreul, MD, PhD principal investigator

Institut National de la Santé Et de la Recherche Médicale, France

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 1 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 18 Feb 2026. 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 France. 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?

Number of suicides - Short term (time frame: At month 9). The study lists 2 primary outcomes in all. 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 NCT03565562, which also lists 25 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 18 Feb 2026.