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Table 1 Items from the World Health Organization (WHO) trial registration data set

From: The PRINTEMPS study: protocol of 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

Data categoryInformation
Primary registry and trial identifying numberClinicalTrials.gov, ID: NCT03565562
Date of registration in primary registry11 June 2018
Secondary identifying numbersGrant from the French Research Institute in Public Health: agreement 026/14
Source of monetary or material supportFrench 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 sponsorClinical Research Department, French National Institute of Health and Medical Research (INSERM), contact: promoteur.inserm@inserm.fr
Secondary sponsorNone
Contact for public queriesPr Karine Chevreul (karine.chevreul@urc-eco.fr)
Contact for scientific queriesPr Karine Chevreul (karine.chevreul@urc-eco.fr) and the PRINTEMPS team (printemps@urc-eco.fr)
Public titleProgramme de Recherche INTerventionnelle et Evaluative Mené pour la Prévention du Suicide (PRINTEMPS)
Scientific titleA 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 recruitmentFrance
Health conditions or problem(s) studiedSuicide, depression, psychological distress
InterventionIntervention 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 criteriaClusters: 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 typeInterventional study with randomized allocation, parallel assignment and no masking for prevention purpose
Date of first enrollment22 August 2018
Target sample size34 clusters for a total of more than 4 million adult inhabitants
Recruitment statusOn-going
Primary outcomeNumber 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 reviewApproved 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)