Preventing Psychological Distress and Suicidal Behaviours: a Web-based and Mobile Suicide Prevention Intervention in the General Population
NCT03565562 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100000
Last updated 2026-02-18
Summary
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.
Conditions
- Suicide and Depression
- Psychological Distress
- Anxiety Disorders
- Local Authorities Promotion
Interventions
- OTHER
-
Promotion of the e-health tool by local authorities
Local authorities participating in the trial will select a referent person who will be in charge of the implementation and follow-up of the promotion. A promotion toolkit with recommendations, posters, web banners, leaflets and ready-made messages and press articles will be provided to the local authorities.
- OTHER
-
Promotion of the e-health tool by local authorities and GPs
In those local authorities, GPs will participate passively to the promotion of the e-health tool, by providing posters and leaflets in their waiting rooms.
Sponsors & Collaborators
-
National Agency of Public Health
collaborator OTHER -
Centre Collaborateur OMS pour la recherche et la formation en santé mentale
collaborator UNKNOWN -
Institut de Recherche en Santé Publique, France
collaborator OTHER -
UMR INSERM 1246 - SPHERE MethodS in Patients-centered outcomes and HEalth ResEarch
collaborator UNKNOWN -
Institut National de la Santé Et de la Recherche Médicale, France
lead OTHER_GOV
Principal Investigators
-
Karine Chevreul, MD, PhD · Institut National de la Santé Et de la Recherche Médicale, France
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-04-01
- Primary Completion
- 2018-12-31
- Completion
- 2020-03-31
Countries
- France
Study Locations
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