STUDY PROTOCOL Open Access
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
Coralie Gandré
1
, Anaïs Le Jeannic
1,2
, Marie-Amélie Vinet
1,2
, Kathleen Turmaine
1
, Philippe Courtet
3,4
,
Jean-Luc Roelandt
1,5
, Guillaume Vaiva
6,7
, Bruno Giraudeau
8,9
, Corinne Alberti
1,10
and Karine Chevreul
1,2*
Abstract
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
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* Correspondence: karine.chevreul@urc-eco.fr
1
Université de Paris, Unité UMR 1123 ECEVE, INSERM, Paris, France
2
Health Economics Clinical Research Platform (URC Eco), AP-HP, 1 Place du
Parvis Notre-Dame, 75004 Paris, France
Full list of author information is available at the end of the article
Gandré et al. Trials (2020) 21:553
https://doi.org/10.1186/s13063-020-04464-2