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, Anaïs Le Jeannic, Marie-Amélie Vinet, Kathleen Turmaine, Philippe Courtet,
Jean-Luc Roelandt, Guillaume Vaiva, Bruno Giraudeau, Corinne Alberti & Karine Chevreul
Coralie Gandré, Anaïs Le Jeannic, Marie-Amélie Vinet, Kathleen Turmaine, Philippe Courtet,
Jean-Luc Roelandt, Guillaume Vaiva, Bruno Giraudeau, Corinne Alberti & Karine Chevreul
Trials
volume 21, Article number: 553 (2020)
Affiliations
Affiliations
Published:
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.
