NCT06921226: RISKY

Exploratory Analysis of Interpersonal and Intrapersonal Psychological Processes Implied in Risk-taking and Suicidal Behaviors, in Adult and Adolescent At-risk

Not yet recruiting NA Last updated 10 April 2025

What this trial tests

NA trial testing Psychological Processes in Suicidal Ideas in 1,400 participants. Not yet recruiting.

Timeline

15 April 2025

Primary endpoint
15 April 2027

15 April 2027

Quick facts

Lead sponsor	Centre Hospitalier Metropole Savoie
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	1,400
Start date	15 April 2025
Primary completion	15 April 2027
Estimated completion	15 April 2027
Sites	3 locations across France

Drugs / interventions tested

• Psychological Processes
• Risk-taking variables
• Suicidal ideation and behavior

Conditions studied

• Suicidal Ideas — all drugs for Suicidal Ideas →
• Suicidal Ideation — all drugs for Suicidal Ideation →
• Risk-taking — all drugs for Risk-taking →

Sponsor

Centre Hospitalier Metropole Savoie

Who can join

Adults 12 to 65, any sex, with Suicidal Ideas or Suicidal Ideation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In a recent report, Santé Publique France (2023), reported that 4.2% of 18-85 year-olds had thought about suicide in the last 12 months, and 6.8% had attempted suicide in their lifetime and 0.5% in the last year. Even more recently, the DREES (Direction de la recherche, des études, de l'évaluation et des statistiques auprès des Ministères Sociaux) published a report on May 16, 2024, showing a sharp rise in hospitalization rates for self-inflicted acts among female patients aged between 10 and 24, with a peak around age 15. Two-thirds of these hospitalizations for self-inflicted injuries are related to deliberate drug intoxication. Depression, bipolar disorders and schizophrenia spectrum disorders (among other psychological disorders) are known risk factors for suicide, which is the leading cause of death in this clinical context. In addition to these formalized psychopathological elements, risk behaviors underpinned by psychological processes common to suicide attempts are suspected and need to be studied in depth.

Research into psychiatry and the psychopathology of suicide has identified a number of risk and protective factors. These psychological determinants - or processes - act alongside other key factors such as the environment and social ties. Life contexts can have an impact on health, and more specifically on the psychopathology of individuals, through disturbances of a biological, psychological and social nature. It is important to be able to describe what processes are at work and how they explain the development and maintenance of behaviours that put one's life and health at risk. This is part of a preventive approach to mental health. We suggest that the study of psychological processes such as suicidal ruminations, impulsivity and interpersonal needs (e.g. the interpersonal theory of suicide) is necessary to understand their involvement in risk-taking and suicidal behavior. To our knowledge, few studies of this type are underway in France, particularly with vulnerable clinical populations (adolescents/adults). The inclusion of a process-centered approach (Kinderman, 2015), in a transdiagnostic and preventive way, constitutes an innovative approach.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.