Suicidal IdeasRISKYNCT06921226
Exploratory Analysis of Interpersonal and Intrapersonal Psychological Processes Implied in Risk-taking and Suicidal Behaviors, in Adult and Adolescent At-risk
A study testing Psychological Processes, Risk-taking variables and Suicidal ideation and behavior in people with Suicidal Ideas and Suicidal Ideation, run by Centre Hospitalier Metropole Savoie at 3 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicidal Ideas, Suicidal Ideation, Risk-taking
- What is being tested?
- Psychological Processes, Risk-taking variables and Suicidal ideation and behavior
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 3 sitesFrance
- Study dates
- 26 Jun 2025to 26 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 12-65 years
- Adolescent population considered as at risk in mental health : admitted to the peadiatric department (CHMS).
- or - Adult population : user of the Espoir73 association (an association for adults with a mental health problem) or users of SM@RT (CHS, a psycho-social rehabilitation center for adults with a mental illness).
Who cannot join
- No suicidal ideation or behaviors (none " Yes " response at the 6 questions of the C-SSRS screen version).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Not yet recruiting
Centre Hospitalier Spécialisé de la Savoie (CHS)
Bassens, 73000
RAINTEAU N, Dr, +334 79 60 32 05, n.rainteau@chs-savoie.fr
Nicolas RAINTEAU
- Recruiting
CH Métropole Savoie
Chambéry, Savoie, 73011
Fabienne M PRIEUR, +33479965999, fabienne.prieur@ch-metropole-savoie.fr
Rosa Maria HERBIGNEAUX
- Recruiting
ESPOIR73
Francin, 73800
Alexandra ALVES-GOMES, 04.79.88.05.51, Alexandra.Alves-Gomes@univ-smb.fr
Alexandra Alves Gomes
About this study
Official title: Intra-personal and Interpersonal Psychological Processes Involved in Risk-taking and Suicidal Behaviors Among Vulnerable Adolescents and Adults
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.
Read the detailed description
The aim of this study is to describe psychological processes that contribute to risk-taking and suicidal behaviors.
The primary objective of this study is: To examine the fit of an Structural Equation Model (SEM) of risk-taking and suicidal behaviors and ideation, and explain those self-destructive behavior can possibly affected by Perceived Burdensomeness (PB) and Thwarted Belongingness (TB), Impulsivity and Suicidal Ruminations (SR) among with suicidal ideations.
This study will address the following secondary objectives:
- To explore the mediating effect of risk-taking, as a behavioral variable, on the relationship between suicidal ideation and behavior and impulsivity.
- To explore the mediating effect of risk-taking, as a self-reported variable, on the relationship between suicidal ideation and behavior and impulsivity.
- To explore the mediating effect of risk-taking, as a cognitive variable, on the relationship between suicidal ideation and behavior and impulsivity.
- To explore the mediating effect of PB on the relationship between SR and suicidal ideation and behavior.
- To explore the mediating effect of TW, on the relationship between SR and suicidal ideation and behavior.
- To explore the mediating effect of SR on the relationship between suicidal ideation and behavior and impulsivity.
The effect of developmental status (adult versus adolescent), will be considerated as a co-variate.
- Conditions
- Suicidal Ideas, Suicidal Ideation, Risk-taking
- Being tested
- Psychological Processes, Risk-taking variables, Suicidal ideation and behavior
- Keywords
- Risk-taking behaviors, Impulsivity, Interpersonal needs, Suicidal ruminations, Suicidal behaviors, BART
- Medical subject headings
- Suicidal Ideation, Risk-Taking, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological ProcessesOther
- The sense of thwarted belonging and perceived burden will be measured using the Interpersonal Needs Questionnaire (INQ; Van Orden et al., 2012). The back-translated French version by Landrault et al. (2019) will be used. This scale is based on a seven-point Likert scale, ranging from 1 (not at all true for me) to 7 (very true for me).
- To assess impulsivity, we will use the short version of the UPPS validated in French by Billieux and colleagues (2012). It comprises 20 items divided into 5 dimensions (negative urgency, positive urgency, lack of premeditation, lack of perseverance and sensation seeking). Participants were asked to respond on a Likert scale from 1 ("I strongly agree") to 4 ("I strongly disagree").
- We will use the French version of the SRS (Suicidal Rumination Scale, Rogers et al., 2022), back-translated for this study. This eight-item scale assesses suicidal ruminations.
Risk-taking variablesOther
- One of the behavioral tasks based on a real-life model of risky decision-making is BART (Lejuez et al., 2002, 2007). It is based on a conceptual framework of balance between reward and loss potential (Leigh, 1999; Lejuez et al., 2002).
- We will measure one of the cognitive aspects of risk-taking behavior, especially the general cognitive decision-making styles (GDMS, from Scott and Bruce, 1995; Gerard et al., 2016).
- We will measure negative (NRTB , Duell et al., 2020) and positive (PRTB, Fryts et al., 2024) self-reported risk-taking behaviour.
Suicidal ideation and behaviorOther
Suicidal ideation and behavior were measured using the screening grid, the Columbia Suicide Severity Rating Scale (C-SSRS screen version, Posner, Brown, Stanley et al., 2011). It is composed of 6 questions, which take into account the potential method of suicide, the presence of suicidal intent and/or ideation with a plan or intention. This scale has high reliability and validity in general paediatric emergencies (Scudder et al., 2023) and psychiatric samples (Campos et al., 2023).
It classifies people as being at low or high risk of suicide, based on the presence or absence of significant active suicidal ideation in the last three months.
| Study group | Role | What they receive |
|---|---|---|
| Procedure based on questionnaires and a computer task | Experimental | This study begins with an initial screening phase. Only individuals exhibiting suicidal ideation and/or behavior, as identified by at least one affirmative response out of six on the C-SSRS scale (Posner et al., 2011), will be eligible to proceed with the study.
Subsequently, they will complete seven questionnaires and one computer task:
* Risk-taking behaviors via a computer task via the Balloon Analogue Risk Task (BART, Lejuez et al., 2002, 2007) and questionnaires (NRTB and PRTB, Duell et al., 2020; Fryts et al., 2024)
* Decision-making styles (GDMS, Scott and Bruce, 1995)
* Impulsivity (UPPS-Short, Billieux et al., 2012)
* Depressive symptoms (CES-D, Fuhrer and Rouillon, 1989)
* Interpersonal needs (INQ, Landrault et al., 2019)
* Suicidal ruminations (SRS, Rogers et al., 2022) Receives: Other: Psychological Processes; Other: Risk-taking variables; Other: Suicidal ideation and behavior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal ideation and behaviors
C-SSRS score (screen version) out of 6
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start26 Jun 2025
- Primary completion26 Jun 2027 (estimated)
- Study completion26 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Metropole Savoie
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Spécialisé de la Savoie (Chambéry), Université Savoie Mont Blanc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921226
- Sponsor's protocol ID
- 2024-A02361-46
- Acronym
- RISKY
- Status last verified
- Oct 2026
- First submitted
- 25 Mar 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McHugh CM, Chun Lee RS, Hermens DF, Corderoy A, Large M, Hickie IB. Impulsivity in the self-harm and suicidal behavior of young people: A systematic review and meta-analysis. J Psychiatr Res. 2019 Sep;116:51-60. doi: 10.1016/j.jpsychires.2019.05.012. Epub 2019 May 17.
PubMed 31195164Rogers ML, Gallyer AJ, Joiner TE. The relationship between suicide-specific rumination and suicidal intent above and beyond suicidal ideation and other suicide risk factors: A multilevel modeling approach. J Psychiatr Res. 2021 May;137:506-513. doi: 10.1016/j.jpsychires.2021.03.031. Epub 2021 Mar 26.
PubMed 33812323Sastre-Buades A, Alacreu-Crespo A, Courtet P, Baca-Garcia E, Barrigon ML. Decision-making in suicidal behavior: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2021 Dec;131:642-662. doi: 10.1016/j.neubiorev.2021.10.005. Epub 2021 Oct 5.
PubMed 34619171Tomova, L., Andrews, J. L., & Blakemore, S.-J. (2021). The importance of belonging and the avoidance of social risk taking in adolescence. Developmental Review, 61, 100981. https://doi.org/10.1016/j.dr.2021.100981
Tucker RP, Hagan CR, Hill RM, Slish ML, Bagge CL, Joiner TE Jr, Wingate LR. Empirical extension of the interpersonal theory of suicide: Investigating the role of interpersonal hopelessness. Psychiatry Res. 2018 Jan;259:427-432. doi: 10.1016/j.psychres.2017.11.005. Epub 2017 Nov 6.
PubMed 29128621Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.
PubMed 22193671