Preventing Psychological Distress and Suicidal Behaviours: a Web-based and Mobile Suicide Prevention Intervention in the General Population

NCT03565562 | Completed

• 1 other identifier: C 15-45
• Study Type: interventional
• Target: 100,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Health promotion; Local authorities involvement; Suicide and attempted suicide; Primary prevention; Psychological Distress

Outcome Measures

Primary Outcomes (2)

• Number of suicides - Short term

  The number of completed suicides will be extracted from the database of the Epidemiology center on medical causes of deaths (CépiDc) for each local authority participating.

  At month 9

• Number of suicide attempts - Short term

  The number of attempted suicides will be extracted from the national database of public and private hospital admissions (PMSI-MCO) and the national emergency database (Oscour).

  At month 9

Secondary Outcomes (16)

• Number of suicides - Long term

  At the end of the trial (month 18)

• Number of suicide attempts - Long term

  At the end of the trial (month 18)

• Costs

  At 9 months and at the end of the trial (month 18)

• Level of health-related quality of life and associated utility of StopBlues users

  At registration, and 1, 2, 3, 6, 12 and 18 months after

• Level of psychological pain of StopBlues users

  At registration, and then at 1, 2, 3, 6, 12 and 18 months

Study Arms (3)

Control group

NO INTERVENTION

Local authorities allocated to this group won't implement any promotion of the e-health tool for the 12 first months. Free access to StopBlues.

Group experimental 1 promotion

ACTIVE COMPARATOR

Local authorities allocated to this group will have to implement the promotion of the e-health tool: the promotion at the local authority level. They will promote the e-health tool using their usual communication methods (local newspapers, local website, bulletin and billboards, posters in the local shops and in the bus stops…). Free access to StopBlues.

Other: Promotion of the e-health tool by local authorities

Group experimental 2 promotion

ACTIVE COMPARATOR

Local authorities allocated to this group will have to implement promotion of the e-health tool: the promotion at local authority and GPs' waiting room level. Local authorities will promote the e-health tool using their usual communication methods (local newspapers, local website, bulletin and billboards, posters in the local shops and in the bus stops...). (similarly to group experimental1) as well as leaflets and posters in GPs' waiting room. Free access to StopBlues.

Other: Promotion of the e-health tool by local authorities; Other: Promotion of the e-health tool by local authorities and GPs

Interventions

Promotion of the e-health tool by local authorities OTHER

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.

Also known as: StopBlues

Group experimental 1 promotion; Group experimental 2 promotion

Promotion of the e-health tool by local authorities and GPs OTHER

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.

Also known as: StopBlues

Group experimental 2 promotion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years
• living in one of the 42 french local authority participating to the trial
• volunteer
• access to internet (smartphone/tablet/computer)

You may not qualify if:

• \<18 years

Sponsors & Collaborators

• UMR INSERM 1246 - SPHERE MethodS in Patients-centered outcomes and HEalth ResEarch: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: lead
• National Agency of Public Health: collaborator
• Centre Collaborateur OMS pour la recherche et la formation en santé mentale: collaborator
• Institut de Recherche en Santé Publique, France: collaborator

Study Sites (1)

Faculté de Médecine Paris Diderot Paris 7

Paris, 75010, France

Location

Related Publications (25)

• Bertolote J, Fleischmann A. A global perspective on the magnitude of suicide mortality. The Oxford Textbook of Suicidology and Suicide Prevention: A Global Perspective. Oxford: Oxford University Press. Wasserman D., Wasserman C.; 2009. p. 91 98.

  BACKGROUND

• Marie-Claude Mouquet, Bellamy V. Suicides et tentatives de suicide en France. Etude et Résultats. Mai 2006;(488).

  BACKGROUND

• O'Dea D, Tucker S. The cost of suicide to society. Wellington: Ministry of Health. 2005.

  BACKGROUND

• Kennelly B. The economic cost of suicide in Ireland. Crisis. 2007;28(2):89-94. doi: 10.1027/0227-5910.28.2.89.

  PMID: 17722690 BACKGROUND

• du Roscoat E, Beck F. Efficient interventions on suicide prevention: a literature review. Rev Epidemiol Sante Publique. 2013 Aug;61(4):363-74. doi: 10.1016/j.respe.2013.01.099. Epub 2013 Jul 10.

  PMID: 23849295 BACKGROUND

• Warnet S. [New national program for the prevention of suicide]. Rev Infirm. 2011 Nov;(175):4. No abstract available. French.

  PMID: 22206200 BACKGROUND

• Ministère des Affaires Sociales et de la Santé. Décret n° 2013-809 du 9 septembre 2013 portant création de l'Observatoire National du Suicide. 2013

  BACKGROUND

• Atkinson NL, Saperstein SL, Pleis J. Using the internet for health-related activities: findings from a national probability sample. J Med Internet Res. 2009 Feb 20;11(1):e4. doi: 10.2196/jmir.1035.

  PMID: 19275980 BACKGROUND

• Dickerson S, Reinhart AM, Feeley TH, Bidani R, Rich E, Garg VK, Hershey CO. Patient Internet use for health information at three urban primary care clinics. J Am Med Inform Assoc. 2004 Nov-Dec;11(6):499-504. doi: 10.1197/jamia.M1460. Epub 2004 Aug 6.

  PMID: 15298993 BACKGROUND

• Haga SM, Drozd F, Brendryen H, Slinning K. Mamma mia: a feasibility study of a web-based intervention to reduce the risk of postpartum depression and enhance subjective well-being. JMIR Res Protoc. 2013 Aug 12;2(2):e29. doi: 10.2196/resprot.2659.

  PMID: 23939459 BACKGROUND

• Monshat K, Vella-Brodrick D, Burns J, Herrman H. Mental health promotion in the Internet age: a consultation with Australian young people to inform the design of an online mindfulness training programme. Health Promot Int. 2012 Jun;27(2):177-86. doi: 10.1093/heapro/dar017. Epub 2011 Mar 11.

  PMID: 21398335 BACKGROUND

• Allen J, Mohatt G, Fok CC, Henry D; People Awakening Team. Suicide prevention as a community development process: understanding circumpolar youth suicide prevention through community level outcomes. Int J Circumpolar Health. 2009 Jun;68(3):274-91. doi: 10.3402/ijch.v68i3.18328.

  PMID: 19705659 BACKGROUND

• Bean G, Baber KM. Connect: an effective community-based youth suicide prevention program. Suicide Life Threat Behav. 2011 Feb;41(1):87-97. doi: 10.1111/j.1943-278X.2010.00006.x. Epub 2011 Jan 24.

  PMID: 21309827 BACKGROUND

• Ono Y, Sakai A, Otsuka K, Uda H, Oyama H, Ishizuka N, Awata S, Ishida Y, Iwasa H, Kamei Y, Motohashi Y, Nakamura J, Nishi N, Watanabe N, Yotsumoto T, Nakagawa A, Suzuki Y, Tajima M, Tanaka E, Sakai H, Yonemoto N. Effectiveness of a multimodal community intervention program to prevent suicide and suicide attempts: a quasi-experimental study. PLoS One. 2013 Oct 9;8(10):e74902. doi: 10.1371/journal.pone.0074902. eCollection 2013.

  PMID: 24130673 BACKGROUND

• Pearson A, Saini P, Da Cruz D, Miles C, While D, Swinson N, Williams A, Shaw J, Appleby L, Kapur N. Primary care contact prior to suicide in individuals with mental illness. Br J Gen Pract. 2009 Nov;59(568):825-32. doi: 10.3399/bjgp09X472881.

  PMID: 19861027 BACKGROUND

• Hegerl U, Althaus D, Schmidtke A, Niklewski G. The alliance against depression: 2-year evaluation of a community-based intervention to reduce suicidality. Psychol Med. 2006 Sep;36(9):1225-33. doi: 10.1017/S003329170600780X. Epub 2006 May 17.

  PMID: 16707028 BACKGROUND

• Chabaud F, Debarre J, Serazin C, Bouet R, Vaiva G, Roelandt JL. [Study of population profiles in relation to the level of suicide risk in France: Study "Mental health in the general population"]. Encephale. 2010;36(3 Suppl):33-8. doi: 10.1016/S0013-7006(10)70016-6. French.

  PMID: 20813223 BACKGROUND

• Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012 Sep 4;345:e5661. doi: 10.1136/bmj.e5661. No abstract available.

  PMID: 22951546 BACKGROUND

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.

  PMID: 20332509 BACKGROUND

• Schmidtke A, Bille-Brahe U, DeLeo D, Kerkhof A, Bjerke T, Crepet P, Haring C, Hawton K, Lonnqvist J, Michel K, Pommereau X, Querejeta I, Phillipe I, Salander-Renberg E, Temesvary B, Wasserman D, Fricke S, Weinacker B, Sampaio-Faria JG. Attempted suicide in Europe: rates, trends and sociodemographic characteristics of suicide attempters during the period 1989-1992. Results of the WHO/EURO Multicentre Study on Parasuicide. Acta Psychiatr Scand. 1996 May;93(5):327-38. doi: 10.1111/j.1600-0447.1996.tb10656.x.

  PMID: 8792901 BACKGROUND

• Réseau OSCOUR® / Surveillance syndromique - SurSaUD® / Veille et alerte / Dossiers thématiques / Accueil [Internet]. Disponible sur: http://www.invs.sante.fr/Dossiers-thematiques/Veille-et-alerte/Surveillance-syndromique-SurSaUD-R/Reseau-OSCOUR-R

  BACKGROUND

• HAS. Choix méthodologiques pour l'évaluation économique à la HAS. 2011

  BACKGROUND

• Dutton GG, Karunaratne DN. Bacteriophage degradation of Klebsiella K44 polysaccharide: an n.m.r. study and chemical proof of the position of the acetate group. Carbohydr Res. 1985 May 15;138(2):277-91. doi: 10.1016/0008-6215(85)85111-9.

  PMID: 4028044 RESULT

• Turmaine K, Dumas A, Chevreul K; PRINTEMPS Consortium. Conditions for the Successful Integration of an eHealth Tool "StopBlues" Into Community-Based Interventions in France: Results From a Multiple Correspondence Analysis. J Med Internet Res. 2022 Apr 22;24(4):e30218. doi: 10.2196/30218.

  PMID: 35451977 RESULT

• Gandre C, Le Jeannic A, Vinet MA, Turmaine K, Courtet P, Roelandt JL, Vaiva G, Giraudeau B, Alberti C, Chevreul K. 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. Trials. 2020 Jun 22;21(1):553. doi: 10.1186/s13063-020-04464-2.

  PMID: 32571432 DERIVED

MeSH Terms

Conditions

Suicide; Depression; Anxiety Disorders; Suicide, Attempted

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Karine Chevreul, MD, PhD

  Institut National de la Santé Et de la Recherche Médicale, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: cluster randomized, open parallel groups , controlled intervention study

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: June 21, 2018
• Study Start: April 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: March 31, 2020
• Last Updated: February 18, 2026

Record last verified: 2019-12

Locations

FR (1)