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.

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  • Additional Information
    • Source:
      Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
    • Publication Information:
      Original Publication: [London] : BioMed Central, 2006-
    • Subject Terms:
      Mobile Applications*/economics ; Smartphone* ; Suicide Prevention*; Health Promotion/*methods ; Telemedicine/*methods; Adult ; Cluster Analysis ; Cost-Benefit Analysis ; Female ; Follow-Up Studies ; France ; Health Promotion/economics ; Humans ; Male ; Mental Health ; Program Evaluation ; Psychological Distress ; Randomized Controlled Trials as Topic ; Suicide/psychology ; Telemedicine/economics
    • 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.
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    • Grant Information:
      026/14 Institut de recherche en santé publique
    • Contributed Indexing:
      Keywords: E-health; General population; Help-seeking; Intervention; Local authorities; Mental health; Prevention; Promotion; Psychological distress; Suicide
    • Molecular Sequence:
      ClinicalTrials.gov NCT03565562
    • Publication Date:
      Date Created: 20200624 Date Completed: 20210317 Latest Revision: 20231111
    • Publication Date:
      20231111
    • Accession Number:
      PMC7309990
    • Accession Number:
      10.1186/s13063-020-04464-2
    • Accession Number:
      32571432