Faculté de Médecine Paris Diderot Paris 7
Paris, 75010, France
NCT Number: NCT03565562
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Paris, 75010, France
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.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: StopBlues
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.
Other names: StopBlues
Time frame: At month 9
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.
Time frame: At month 9
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).
Time frame: At the end of the trial (month 18)
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.
Time frame: At the end of the trial (month 18)
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).
Time frame: At 9 months and at the end of the trial (month 18)
Fixed costs for the development of the intervention including promotions tools, semi-fixed costs for the implementation of the program by local authorities and GPs, costs of suicidal acts.
Time frame: At registration, and 1, 2, 3, 6, 12 and 18 months after
Collected through self-assessment at the user level with the quality of life questionnaire Short Form-12 (SF-12).
Time frame: At registration, and then at 1, 2, 3, 6, 12 and 18 months
Collected through self-assessment at the user level with the 12-item General Health Questionnaire (GHQ-12).
Time frame: At registration, and then at 1, 2, 3, 6, 12 and 18 months
Collected through self-assessment at the user level with the Patient Health Questionnaire (PHQ-9)
Time frame: At registration, and then at 1, 2, 3, 6, 12 and 18 months
Collected through self-assessment at the user level with the General Anxiety Disorder questionnaire (GAD-7).
Time frame: At first filling and 1, 2, 3, 6, 12 and 18 months after
Collected through self-assessment at the user level with the 6 questions on the suicidal risk of the Mini International Neuropsychiatric Interview-Simplified (MINI-S). The MINI-S is not available at registration, it will be triggered when results to GHQ-12, PHQ-9 and/or GAD-7 are considered showing a suicidal risk for the user.
Time frame: At registration, and 1, 2, 3, 6, 12 and 18 months after
Collected through self-assessment at the user level with an ad hoc questionnaire adapted from the general health-seeking questionnaire (GHSQ).
Time frame: At registration
Collected at the user level with the Montgomery-Asberg Depression Scale (MADRS). It has 10 questions, quoted from 0 to 6.
Time frame: 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
French traduction of the first question of the General Help-Seeking Questionnaire -Original Version (GHSQ).
Time frame: At month 9 and 18 (end of the trial)
Number of downloads and connections for each zip codes of local authorities included in the trial.
Time frame: At month 9 and 18 (end of the trial)
Time-lapse between the inscription and the last connection to the application or website.
Time frame: At registration
Collected at the user level with a specific question: "How did you get to know about the StopBlues program?" .
1/ By public display 2/ In public places (employment center, library ...) 3/ On my city website 4/ By the press 5/ Through social networks 6/ At merchants 7/ At my pharmacist 8/ At my GP 9/ At another health professional (physiotherapist, medical specialist ...) 10/Through relationships (friends, families, neighbors ...) 11/ Other
Time frame: At registration
The proportion of users who subscribed for a relative and not for themselves.
Time frame: At month 9 and 18 (end of the trial)
The proportion of users who filled up a safety plan.
Institut National de la Santé Et de la Recherche Médicale, France
Other Gov
Acronym: PRINTEMPS
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