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

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ClinicalTrials.gov Identifier: NCT03565562
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : January 27, 2020
Sponsor:
Collaborators:
National Agency of Public Health
Centre Collaborateur OMS pour la recherche et la formation en santé mentale
Institut de Recherche en Santé Publique, France
UMR INSERM 1246 - SPHERE MethodS in Patients-centered outcomes and HEalth ResEarch
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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.

Condition or disease Intervention/treatment Phase
Suicide and Depression Psychological Distress Anxiety Disorders Local Authorities Promotion Other: Promotion of the e-health tool by local authorities Other: Promotion of the e-health tool by local authorities and GPs Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: cluster randomized, open parallel groups , controlled intervention study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Psychological Distress and Suicidal Behaviours: a Web-based and Mobile Suicide Prevention Intervention in the General Population
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
No Intervention: Control group
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.
Active Comparator: Group experimental 1 promotion
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
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 Name: StopBlues

Active Comparator: Group experimental 2 promotion
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
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 Name: StopBlues

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.
Other Name: StopBlues




Primary Outcome Measures :
  1. Number of suicides - Short term [ 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.

  2. Number of suicide attempts - Short term [ 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).


Secondary Outcome Measures :
  1. Number of suicides - Long term [ 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.

  2. Number of suicide attempts - Long term [ 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).

  3. Costs [ 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.

  4. Level of health-related quality of life and associated utility of StopBlues users [ 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).

  5. Level of psychological pain of StopBlues users [ 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).

  6. Level of depression of StopBlues users [ 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)

  7. Level of anxiety of StopBlues users [ 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).

  8. Level of suicidal risk of StopBlues users [ 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.

  9. Help-seeking behaviors and implementation of supportive activities into daily life of StopBlues users [ 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).

  10. Level of depression (for StopBlues users coming for a relative) [ 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.

  11. Intention to seek help of StopBlues users [ 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).

  12. Intensity of the participation to the application and website [ 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.

  13. Length of use to the application and website [ 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.

  14. Proportion of StopBlues users who came to know the e-health tool through the different communication channels [ 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


  15. Proportion of StopBlues users who came for a relative [ Time Frame: At registration ]
    The proportion of users who subscribed for a relative and not for themselves.

  16. StopBlues users with a safety plan [ Time Frame: At month 9 and 18 (end of the trial) ]
    The proportion of users who filled up a safety plan.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565562


Contacts
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Contact: Karine Chevreul, MD, PhD 003340274148 printemps@urc-eco.fr

Locations
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France
Faculté de Médecine Paris Diderot Paris 7 Recruiting
Paris, France, 75010
Contact: Karine Chevreul, MD, PhD    (0)140274148    karine.chevreul@urc-eco.fr   
Contact: Kathleen Turmaine, MD    (0)140275285    kathleen.turmaine@urc-eco.fr   
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
National Agency of Public Health
Centre Collaborateur OMS pour la recherche et la formation en santé mentale
Institut de Recherche en Santé Publique, France
UMR INSERM 1246 - SPHERE MethodS in Patients-centered outcomes and HEalth ResEarch
Investigators
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Principal Investigator: Karine Chevreul, MD, PhD Institut National de la Santé Et de la Recherche Médicale, France
Publications:
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.
Marie-Claude Mouquet, Bellamy V. Suicides et tentatives de suicide en France. Etude et Résultats. Mai 2006;(488).
O'Dea D, Tucker S. The cost of suicide to society. Wellington: Ministry of Health. 2005.
Programme national d'actions contre le suicide 2011-2014. 2011
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
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
HAS. Choix méthodologiques pour l'évaluation économique à la HAS. 2011

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT03565562    
Other Study ID Numbers: C 15-45
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Health promotion
Local authorities involvement
Suicide and attempted suicide
Primary prevention
Psychological Distress
Additional relevant MeSH terms:
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Anxiety Disorders
Suicide
Behavioral Symptoms
Mental Disorders
Self-Injurious Behavior