Clinical trial NCT03565562: Preventing Psychological Distress and Suicidal Behaviours: a Web-based and Mobile Suicide Prevention Intervention in the General Population
Official title: Preventing Psychological Distress and Suicidal Behaviours: a Web-based and Mobile Suicide Prevention Intervention in the General Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: National Agency of Public Health
name: Centre Collaborateur OMS pour la recherche et la formation en santé mentale
name: Institut de Recherche en Santé Publique, France
name: UMR INSERM 1246 - SPHERE MethodS in Patients-centered outcomes and HEalth ResEarch
First posted: 2018-06-21
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster randomized, open parallel groups , controlled intervention study
Primary purpose: PREVENTION

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.

Detailed description: * 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* \<18 years

Primary outcomes:
measure: Number of suicides - Short term
timeFrame: At month 9
measure: Number of suicide attempts - Short term
timeFrame: At month 9
Secondary outcomes:
measure: Number of suicides - Long term
timeFrame: At the end of the trial (month 18)
measure: Number of suicide attempts - Long term
timeFrame: At the end of the trial (month 18)
measure: Costs
timeFrame: At 9 months and at the end of the trial (month 18)
measure: Level of health-related quality of life and associated utility of StopBlues users
timeFrame: At registration, and 1, 2, 3, 6, 12 and 18 months after
measure: Level of psychological pain of StopBlues users
timeFrame: At registration, and then at 1, 2, 3, 6, 12 and 18 months
measure: Level of depression of StopBlues users
timeFrame: At registration, and then at 1, 2, 3, 6, 12 and 18 months
measure: Level of anxiety of StopBlues users
timeFrame: At registration, and then at 1, 2, 3, 6, 12 and 18 months
measure: Level of suicidal risk of StopBlues users
timeFrame: At first filling and 1, 2, 3, 6, 12 and 18 months after
measure: Help-seeking behaviors and implementation of supportive activities into daily life of StopBlues users
timeFrame: At registration, and 1, 2, 3, 6, 12 and 18 months after
measure: Level of depression (for StopBlues users coming for a relative)
timeFrame: At registration
measure: Intention to seek help of StopBlues users
timeFrame: At registration for users coming for a relative, and at registration and 1, 2, 3, 6, 12 and 18 months after for users coming for themselves
measure: Intensity of the participation to the application and website
timeFrame: At month 9 and 18 (end of the trial)
measure: Length of use to the application and website
timeFrame: At month 9 and 18 (end of the trial)
measure: Proportion of StopBlues users who came to know the e-health tool through the different communication channels
timeFrame: At registration
measure: Proportion of StopBlues users who came for a relative
timeFrame: At registration
measure: StopBlues users with a safety plan
timeFrame: At month 9 and 18 (end of the trial)
Other outcomes:
Locations:
city: Paris
country: France
facility: Faculté de Médecine Paris Diderot Paris 7
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Karine Chevreul, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Marie-Claude Mouquet, Bellamy V. Suicides et tentatives de suicide en France. Etude et Résultats. Mai 2006;(488).
citation: O'Dea D, Tucker S. The cost of suicide to society. Wellington: Ministry of Health. 2005.
citation: Kennelly B. The economic cost of suicide in Ireland. Crisis. 2007;28(2):89-94. doi: 10.1027/0227-5910.28.2.89.
citation: 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.
citation: Warnet S. [New national program for the prevention of suicide]. Rev Infirm. 2011 Nov;(175):4. No abstract available. French.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: HAS. Choix méthodologiques pour l'évaluation économique à la HAS. 2011
citation: 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.
citation: 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.