Anxiety Disorders Clinical Trial
Official title:
Preventing Psychological Distress and Suicidal Behaviours: a Web-based and Mobile Suicide Prevention Intervention in the General Population
An interventional research study will be undertaken to assess the effectiveness of the promotion at the local level of an e-health tool for suicide and psychological distress prevention (the StopBlues application and website). This trial is a cluster-randomized, parallel group, controlled intervention study with local authorities as the unit of randomization. Local authorities will be randomly assigned to one of the following three arms: local authorities not promoting the e-health tool (control group); local authorities promoting the e-health tool without general practitioners (GPs) involvement; local authorities promoting the e-health tool including GPs' waiting room. The trial will last 24 months and after a 12-month post-randomization period, local authorities from the control group will be allowed for a further 12-month period to launch their promotional campaign supported by the research team through regular contacts and additional technical and financial resources (intensively sustained promotion). This will facilitate the recruitment of clusters as well as their adherence to the intervention during the first 12-month period. The main criterion will be the number of suicidal acts at nine months. Data will be collected both at the local authority level and at the individual e-health tool user level.
- Context France is one of the Western European countries most affected by suicide, which
is associated with a high societal cost. Recently, a European project aiming to develop
best practice for suicide prevention has recommended the development of web-based
interventions and the French national plan for actions against suicide has supported the
development of reference websites for suicide prevention. However, web-based
interventions should be associated with effective promotional efforts to ensure
awareness but also to improve receptiveness among and around those who could benefit
from such a resource. Previous work has shown that local authorities are appropriate
actors for promoting prevention measures against suicide and that 20% of individuals
attempting suicide visit their GP the day before their attempt.
- Research objectives The primary objective of our trial is to assess the effectiveness of
the tailored promotion at local level of an e-health tool and to compare the
effectiveness at 12 months of two types of local promotion (with or without involving
GPs' waiting room) on suicidal acts. The secondary objectives are to assess the
cost-effectiveness and to run a budgetary impact analysis of the intervention. Moreover,
our secondary objectives are to assess the effectiveness of the promotion on the
intensity of utilization of StopBlues by the three types of users (living in a city
without promotion or with promotion or reinforced promotion), on their help-seeking
behavior, on their implementation of supportive activities into their daily life and on
the evolution of users level of psychological impairment. An additional form of
promotion (intensively sustained promotion) will be implemented after 12 months in the
control group and evaluated using the same primary outcome measure. In parallel, the
long-term effectiveness of the two main types of local promotion (with or without a
passive involvement of GPs through their waiting room) will also be assessed.
- Methodology The detailed content of the e-health tool and the promotional tools to be
made available to local authorities and GPs was determined through literature reviews
and focus groups with experts and users.
A cluster-randomized, parallel group, controlled intervention study with local authorities as
the unit of randomization will be set up. Local authorities can either be cities or a
grouping of cities ("communauté de communes"), based on the local health governance of each
area. If several adjacent local authorities volunteer individually to participate in the
trial, they will be considered as a unique local authority. Volunteer local authorities will
be randomly assigned to one of the following three arms: those not promoting the e-health
tool (control group); those promoting the e-health tool without involving GPs' waiting rooms;
those promoting the e-health tool involving GPs' waiting rooms.
The trial will last 24 months and local authorities will be able to switch arm if they so
wish after 12 months and launch an 'intensively sustained promotion'. This will facilitate
recruitment of local authorities as well as their adherence to the intervention. Data will be
collected both at the local authority level and at the individual user level.
• Expected results The investigators anticipate that the promotion of the e-health
intervention will lead to a greater difference in the number of suicidal acts in the local
authorities where it is implemented over the trial period. Furthermore, it should also result
in a higher reduction of psychological distress and in an increased intensity and length of
use of the e-health tool. The promotion may also lead members of the population with moderate
level of psychological distress, who may not otherwise be seeking help, to access the
e-health tool and should also facilitate help-seeking behaviors and implementation of
supportive activities into their daily life. The intensively sustained promotion should lead
to higher rates of connexion and by then to a higher reduction of psychological distress and
in an increased intensity and length of use of the e-health tool.
Moreover, this project will give information on the relevance of our promotion model for
primary prevention of psychological distress. Indeed, if the findings are satisfactory, this
model and the formalized networks for promotion within local authorities may facilitate
development of additional primary prevention measures both for mental disorders and other
health issues.
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