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NCT03565562: PRINTEMPS
Preventing Psychological Distress and Suicidal Behaviours: a Web-based and Mobile Suicide Prevention Intervention in the General Population
NA trial testing Promotion of the e-health tool by local authorities in Suicide and Depression in 100,000 participants. Completed in 31 March 2020.
31 December 2018
Quick facts
| Lead sponsor | Institut National de la Santé Et de la Recherche Médicale, France |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 100,000 |
| Start date | 1 April 2018 |
| Primary completion | 31 December 2018 |
| Estimated completion | 31 March 2020 |
| Sites | 1 location across France |
Drugs / interventions tested
- Promotion of the e-health tool by local authorities
- Promotion of the e-health tool by local authorities and GPs
Conditions studied
- Suicide and Depression — all drugs for Suicide and Depression →
- Psychological Distress — all drugs for Psychological Distress →
- Anxiety Disorders — all drugs for Anxiety Disorders →
- Local Authorities Promotion — all drugs for Local Authorities Promotion →
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France — full company profile →
Who can join
18 and older, any sex, with Suicide and Depression or Psychological Distress. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
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.
Gandré C, Le Jeannic A, Vinet MA, Turmaine K, et al · · 2020 · cited 5× · PMID 32571432 · DOI 10.1186/s13063-020-04464-2 -
Defining the Characteristics of an e-Health Tool for Suicide Primary Prevention in the General Population: The StopBlues Case in France.
Le Jeannic A, Turmaine K, Gandré C, Vinet MA, et al · · 2023 · cited 3× · PMID 37372683 · DOI 10.3390/ijerph20126096 -
Conditions for the Successful Integration of an eHealth Tool "StopBlues" Into Community-Based Interventions in France: Results From a Multiple Correspondence Analysis.
Turmaine K, Dumas A, Chevreul K, PRINTEMPS Consortium. · · 2022 · cited 2× · PMID 35451977 · DOI 10.2196/30218
Verify or expand the search:
- PubMed search for NCT03565562
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03565562 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institut National de la Santé Et de la Recherche Médicale, France
- Last refreshed: 18 February 2026
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