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

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 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

Suicide Prevention in Your Pocket: A Systematic Review of Ecological Momentary Interventions for the Management of Suicidal Thoughts and Behaviors

“…The intraclass correlation coefficient among reviewers was 78.9 (95% confidence interval, 77.4–80.3). The characteristics and main findings of the reviewed studies are presented in Tables 1 and 2 15–41 …”

Conditions for the Successful Integration of an eHealth Tool "StopBlues" Into Community-Based Interventions in France: Results From a Multiple Correspondence Analysis

“…A three-arm, parallel-group CRCT was conducted to evaluate the effectiveness of the promotion with before and after observation [ 29 ]. 42 localities volunteered to be randomly allocated to one of the following three arms with a ratio of 1:1:1 ( Figure 1 ; Multimedia Appendix 2 ):…”

“…StopBlues (SB) is a first-of-its-kind website and mobile application in France that aims at preventing mental distress and suicide [ 29 ]. It was originally created in 2018 within a CBHP intervention, carried out in a sample of municipalities and associations of municipalities (referred to in this paper as “localities”) where the tool was specifically promoted [ 29 ].…”

“…StopBlues (SB) is a first-of-its-kind website and mobile application in France that aims at preventing mental distress and suicide [ 29 ]. It was originally created in 2018 within a CBHP intervention, carried out in a sample of municipalities and associations of municipalities (referred to in this paper as “localities”) where the tool was specifically promoted [ 29 ]. The idea was to anchor SB in local settings by offering the localities a ready-to-use eHealth tool, along with a promotional toolkit that they could customize and adapt to local needs.…”

“…Importantly, SB was included in a full evaluation program, in contrast to the limited research conducted via controlled trials or in real-world settings to evaluate the public health impact of eHT and mobile health applications, in particular [ 32 , 33 ]. The evaluation included a cluster-randomized, controlled trial (CRCT) [ 29 ] associated with qualitative research in order to better understand the implementation and identify the optimal conditions to ensure its utilization.…”