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

Anxiety Disorders Clinical Trial

— PRINTEMPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03565562
• Other study ID #: C 15-45
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: December 2019
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Karine Chevreul, MD, PhD
• Phone: 003340274148
• Email: printemps[@]urc-eco.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: March 31, 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Local Authorities Promotion
• Psychological Distress
• Suicide
• Suicide and Depression

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Faculté de Médecine Paris Diderot Paris 7	Paris

Sponsors (5)

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

Country where clinical trial is conducted

France, 

References & Publications (22)

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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. — View Citation

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Schmidtke A, Bille-Brahe U, DeLeo D, Kerkhof A, Bjerke T, Crepet P, Haring C, Hawton K, Lönnqvist J, Michel K, Pommereau X, Querejeta I, Phillipe I, Salander-Renberg E, Temesváry 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. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of suicides - Long 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 the end of the trial (month 18)
Secondary	Number of suicide attempts - Long 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 the end of the trial (month 18)
Secondary	Costs	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.	At 9 months and at the end of the trial (month 18)
Secondary	Level of health-related quality of life and associated utility of StopBlues users	Collected through self-assessment at the user level with the quality of life questionnaire Short Form-12 (SF-12).	At registration, and 1, 2, 3, 6, 12 and 18 months after
Secondary	Level of psychological pain of StopBlues users	Collected through self-assessment at the user level with the 12-item General Health Questionnaire (GHQ-12).	At registration, and then at 1, 2, 3, 6, 12 and 18 months
Secondary	Level of depression of StopBlues users	Collected through self-assessment at the user level with the Patient Health Questionnaire (PHQ-9)	At registration, and then at 1, 2, 3, 6, 12 and 18 months
Secondary	Level of anxiety of StopBlues users	Collected through self-assessment at the user level with the General Anxiety Disorder questionnaire (GAD-7).	At registration, and then at 1, 2, 3, 6, 12 and 18 months
Secondary	Level of suicidal risk of StopBlues users	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.	At first filling and 1, 2, 3, 6, 12 and 18 months after
Secondary	Help-seeking behaviors and implementation of supportive activities into daily life of StopBlues users	Collected through self-assessment at the user level with an ad hoc questionnaire adapted from the general health-seeking questionnaire (GHSQ).	At registration, and 1, 2, 3, 6, 12 and 18 months after
Secondary	Level of depression (for StopBlues users coming for a relative)	Collected at the user level with the Montgomery-Asberg Depression Scale (MADRS). It has 10 questions, quoted from 0 to 6.	At registration
Secondary	Intention to seek help of StopBlues users	French traduction of the first question of the General Help-Seeking Questionnaire -Original Version (GHSQ).	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
Secondary	Intensity of the participation to the application and website	Number of downloads and connections for each zip codes of local authorities included in the trial.	At month 9 and 18 (end of the trial)
Secondary	Length of use to the application and website	Time-lapse between the inscription and the last connection to the application or website.	At month 9 and 18 (end of the trial)
Secondary	Proportion of StopBlues users who came to know the e-health tool through the different communication channels	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	At registration
Secondary	Proportion of StopBlues users who came for a relative	The proportion of users who subscribed for a relative and not for themselves.	At registration
Secondary	StopBlues users with a safety plan	The proportion of users who filled up a safety plan.	At month 9 and 18 (end of the trial)