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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03565562 on ClinicalTrials.gov