|Primary registry and trial identifying number||ClinicalTrials.gov, ID: NCT03565562|
|Date of registration in primary registry||11 June 2018|
|Secondary identifying numbers||Grant from the French Research Institute in Public Health: agreement 026/14|
|Source of monetary or material support||French Public Health Agency (Santé Publique France) in the frame of the primary prevention call for proposal of the French Research Institute in Public Health|
|Primary sponsor||Clinical Research Department, French National Institute of Health and Medical Research (INSERM), contact: email@example.com|
|Contact for public queries||Pr Karine Chevreul (firstname.lastname@example.org)|
|Contact for scientific queries||Pr Karine Chevreul (email@example.com) and the PRINTEMPS team (firstname.lastname@example.org)|
|Public title||Programme de Recherche INTerventionnelle et Evaluative Mené pour la Prévention du Suicide (PRINTEMPS)|
|Scientific title||A cluster-randomized controlled trial of the local promotion of a smartphone application and associated website for the prevention of suicidal behaviors in the adult general population in France|
|Country of recruitment||France|
|Health conditions or problem(s) studied||Suicide, depression, psychological distress|
|Intervention||Intervention 1: tailored promotion of the e-health StopBlues program at the cluster level without involving general practitioners.|
Intervention 2: tailored promotion of the e-health StopBlues program at the cluster level with passive involvement of general practitioners through their waiting room.
Control intervention: no promotion of the StopBlues program.
|Key inclusion and exclusion criteria||Clusters: geographical areas with volunteer local authorities located in France (mainland and overseas territories) which provided a signed agreement to participate|
Participants: all adults living in participating clusters
|Study type||Interventional study with randomized allocation, parallel assignment and no masking for prevention purpose|
|Date of first enrollment||22 August 2018|
|Target sample size||34 clusters for a total of more than 4 million adult inhabitants|
|Primary outcome||Number of suicidal acts at the cluster level during a 12-month period, including deaths by suicide and suicide attempts.|
Data will be extracted from administrative databases.
|Key secondary outcomes|| Number of deaths by suicide and suicide attempts during a 24-month period|
Cost-effectiveness and budgetary impact analysis: fixed costs for the development of the promotion tools, semi-fixed costs for the implementation of the intervention, costs of suicidal acts, level of health-related quality of life and associated utility (validated questionnaire).
For participants who used the StopBlues program:
Effect on the intensity of the utilization of the StopBlues program by its users: number of downloads and connections for each zip code corresponding to local authorities included in the trial, time-lapse between the registration and the last connection to the StopBlues program for each user, proportion of users who came to know the program through the different communication channels, proportion of users who registered for a relative and not for themselves, proportion of users who completed a safety plan.
Effect on the help-seeking behaviors of users of the StopBlues program and their participation in supportive activities: help-seeking and participation in supportive activities collected with an ad hoc questionnaire adapted from a validated one.
Effect on the level of psychological impairment of the users of the StopBlues program: level of psychological distress, depression, anxiety, suicidal risk (validated questionnaires)
(see Table 2 for more details)
|Ethics review||Approved by the Ethics Committee of the French National Institute for Health and Medical Research (Approval n° 15–240 of 7 of July 2015).|
Approved by the French Advisory Committee for Data Processing in Health Research (Approval n° 15–793 of 30 September 2015).
Approved by the French Data Protection Authority (Decision DR-2016-421 of 3 November 2016)