Background Suicide constitutes a cause of death which could be prevented by e-health programs accessible to the general population. Effective promotion has the potential to maximize the uptake of such programs. However, few e-health programs have been combined with promotion campaigns. The primary objective of this trial is to assess the effectiveness of a tailored promotion, at a local level, of a mobile application and website offering evidence-based content for suicide prevention (the StopBlues program), and to compare the effectiveness of two types of local promotion in terms of their impact on suicidal acts. Secondary objectives focus on the effectiveness of the promotion in terms of the intensity of utilization of the StopBlues program, help-seeking behaviors and the level of psychological impairment of program users. Methods/design This is a three-arm, parallel-group, cluster-randomized controlled trial, with before-and-after observation. Thirty-four clusters, corresponding to geographical areas sharing a common local authority in France, will be included. They will be randomly assigned to one of the following arms with a ratio of 1:1:1: a control group; a basic promotion group in which promotion of the StopBlues program will be done by local authorities; and an intensified promotion group in which basic promotion will be supplemented by an additional one in a general practitioner’s waiting room. The primary outcome measure will be the number of suicidal acts within each cluster over a 12-month period following the launch of the intervention. Baseline data will be collected for each cluster over the 12-month period prior to the trial. Secondary outcomes will include length of use of the StopBlues program, measures of help-seeking behaviors and level of psychological distress among users of the program, as well as the cost-effectiveness and budgetary impact of its promotion. A more sustained promotion by local authorities will also be implemented after 12 months in the control group and assessed using the same outcome measures. Discussion This research should contribute to the sparse evidence base regarding the promotion of e-health programs and will support the wider delivery of the intervention evaluated if proven effective. Trial registration ClinicalTrials.gov, ID: NCT03565562. Registered on 11 June 2018

With over one million deaths per year in the world, suicide is a major public health problem that could be significantly reduced by effective prevention programs. E-health tools are of particular interest for primary prevention as they can address a broad population including people unaware of their own risk and provide information and help without the fear of stigma. Our main objective was to define the overall characteristics of an e-health tool for suicide primary prevention in the French general population by defining the characteristics of the IT features; the content of the information delivered; the best way to structure it; and how it should be relayed and by whom. The research was carried out through a literature review and a co-construction phase with stakeholders. Four types of strategies may guide the construction of e-health tools for suicide primary prevention: education and awareness, (self-)screening, accessing support, and mental health coping. They should be accessible on different devices to reach the most users, and language and content should be adapted to the target population and to the issue being addressed. Finally, the tool should be consistent with ethical and quality best practices. The e-health tool StopBlues was developed following those recommendations.

BACKGROUND With more than a million deaths per year and nearly one out of two people with suicidal thoughts not receiving any form of care in high-income countries, suicide is a major public health problem and a cause of avoidable mortality which could be significantly reduced by effective prevention programs. E-health tools present the advantage of addressing a broad population including people unaware of their potential risk of suicide, and provide an opportunity to look for information and help without fearing stigmatization. This could make them an effective tool for primary prevention programs, even in some hard-to-reach populations. OBJECTIVE Our main objective was to define the overall characteristics of an e-health tool for the primary prevention of suicide in the French general population. Intermediate objectives were to define 1/ the characteristics of the IT features; 2/ the content of the information delivered; 3/ the best way to structure that information; and 4/ how the information should be relayed and by whom. METHODS The research was carried out in two phases: 1/ a literature review was conducted to gather knowledge on existing interventions that may already have proved their effectiveness, and on guidelines for suicide prevention programs; and 2/ a co-construction phase was carried out through a participative process (focus groups and interviews) with stakeholders, including the target population, to ensure that the needs of individuals would be met. RESULTS E-health tools for suicide primary prevention in the general population may be constructed around four types of strategies: education and awareness, (self-)screening, accessing support, and mental health coping. They should be accessible on different devices to reach the most users, and language and content should be adapted to the target population and to the issue being addressed. Finally, the tool should be consistent with ethical and quality best practices. StopBlues was developed following those recommendations and is the first of its kind in France, an e-health tool for prevention with numerous functionalities to help people with psychological distress. CONCLUSIONS E-health tools for suicide prevention offer many advantages when adapted to the need of the population: 1/ great accessibility, 2/ users’ anonymity with reduction of shame, 3/ adaptation of health interventions to new cultural practices, and 4/ the possibility to regroup in one tool many functionalities. Those can be an important part of users’ empowerment process, by helping them manage their illness on their own and gain autonomy, therefore improving their well-being. However, it is important to remember that this type of tools should be developed not to make up for the potential lack of healthcare services but to propose a reliable tool to help people evaluate themselves and be directed to the healthcare system at early stages of their illness. CLINICALTRIAL Preventing Psychological Distress and Suicidal Behaviours: a Web-based and Mobile Suicide Prevention Intervention in the General Population (PRINTEMPS) NCT03565562 https://clinicaltrials.gov/ct2/show/NCT03565562 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s13063-020-04464-2