Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03565562
Study type Interventional
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact Karine Chevreul, MD, PhD
Phone 003340274148
Email printemps@urc-eco.fr
Status Recruiting
Phase N/A
Start date April 1, 2018
Completion date March 31, 2020

See also
  Status Clinical Trial Phase
Completed NCT03535805 - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Recruiting NCT05419934 - EMDR Therapy in Young Children, a Double-blinded Randomized Controlled Trial N/A
Active, not recruiting NCT04136054 - Better Sleep in Psychiatric Care - Anxiety and Affective Disorders N/A
Completed NCT04091139 - Research of Unified Protocol for the Treatment of Common Mental Disorders in Adolescents in Hong Kong Phase 2/Phase 3
Completed NCT04647318 - Physiological Response to Self-compassion Versus Relaxation N/A
Active, not recruiting NCT05114824 - Acceptability and Feasibility of an 8-week Online Mindfulness-Based Cognitive Therapy Program Among Undergraduate Students N/A
Recruiting NCT05843695 - Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety N/A
Completed NCT05078450 - Mood Lifters Online for Graduate Students and Young Professionals N/A
Not yet recruiting NCT06162624 - Pilot Effectiveness Trial of an ACT Self-help Workbook Tailored Specifically for Prisons N/A
Not yet recruiting NCT05863637 - Intensive Short-Term Dynamic Psychotherapy (ISTDP) for Anxiety Diagnoses in a Primary Care Setting N/A
Not yet recruiting NCT05747131 - Emotion Detectives In-Out: Feasibility and Efficacy of a Blended Version of the Unified Protocol for Children N/A
Not yet recruiting NCT05225701 - Efficacy of a Transdiagnostic Guided Internet-Delivered Intervention for Emotional, Trauma and Stress-Related Disorders. N/A
Completed NCT02579915 - Developing a Low-Intensity Primary Care Intervention for Anxiety Disorders (AIM-PC) N/A
Recruiting NCT02376959 - Effect of Spiritist "Passe" Energy Therapy in Reducing Anxiety in Volunteers N/A
Recruiting NCT02186366 - Efficacy Study of Abdominal Massage Therapy to Treat Generalized Anxiety Disorder of Deficiency of Both Heart and Spleen Type N/A
Not yet recruiting NCT02126787 - Short-term, Intensive Psychodynamic Group Therapy Versus Cognitive-behavioral Group Therapy in the Day Treatment N/A
Completed NCT02134730 - School-based Universal Prevention for Anxiety and Depression in Sweden: A Cluster-randomized Trial N/A
Withdrawn NCT01953042 - Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders N/A
Completed NCT01333098 - Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders Phase 1/Phase 2