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RecruitingNCT06921226RISKYUpdated Oct 7, 2026

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

An interventional study of Psychological Processes and Risk-taking variables in Suicidal Ideas, Suicidal Ideation and Risk-taking, sponsored by Centre Hospitalier Metropole Savoie. Recruiting at 3 sites in France. Open to participants aged 12 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Centre Hospitalier Metropole Savoie · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,400
Allocation
Not applicable
Ages
12 Years to 65 Years
Sex
All
01

Study 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. 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:

  1. To explore the mediating effect of risk-taking, as a behavioral variable, on the relationship between suicidal ideation and behavior and impulsivity.
  2. To explore the mediating effect of risk-taking, as a self-reported variable, on the relationship between suicidal ideation and behavior and impulsivity.
  3. To explore the mediating effect of risk-taking, as a cognitive variable, on the relationship between suicidal ideation and behavior and impulsivity.
  4. To explore the mediating effect of PB on the relationship between SR and suicidal ideation and behavior.
  5. To explore the mediating effect of TW, on the relationship between SR and suicidal ideation and behavior.
  6. 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.

02

Conditions studied

  • Suicidal Ideas
  • Suicidal Ideation
  • Risk-taking

Keywords

  • Risk-taking behaviors
  • Impulsivity
  • Interpersonal needs
  • Suicidal ruminations
  • Suicidal behaviors
  • BART
03

In context

Suicidal Ideation

569 studies on the registry are indexed under Suicidal Ideation; 203 are open to participants now.

This study's planned enrollment of 1,400 is above the median of 80 across 469 interventional studies indexed under Suicidal Ideation.

Browse Suicidal Ideation studies →

Lead sponsor

Centre Hospitalier Metropole Savoie is the lead sponsor of 22 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

- No suicidal ideation or behaviors (none " Yes " response at the 6 questions of the C-SSRS screen version).

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,400 participants (estimated)

Study arms

  • Experimental
    Procedure based on questionnaires and a computer task

    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)

    Other: Psychological Processes · Other: Risk-taking variables · Other: Suicidal ideation and behavior

Interventions

  • OtherPsychological Processes

    * 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.

  • OtherRisk-taking variables

    * 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.

  • OtherSuicidal ideation and behavior

    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.

06

What researchers measure

Primary outcomes

  1. Suicidal ideation and behaviors

    C-SSRS score (screen version) out of 6

    Time frame: At inclusion

07

Study locations

2 of 3 sites recruiting
  • CH Métropole Savoie
    Chambéry, Savoie 73011, France
    Recruiting
  • Centre Hospitalier Spécialisé de la Savoie (CHS)
    Bassens, 73000, France
    Not yet recruiting
  • ESPOIR73
    Francin, 73800, France
    Recruiting
    • Alexandra ALVES-GOMES · ContactAlexandra.Alves-Gomes@univ-smb.fr · 04.79.88.05.51
    • Alexandra Alves Gomes · Principal investigator
    • Chloé SIMUS · Sub investigator
08

References and documents

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 31195164 ↗
  • Rogers 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 33812323 ↗
  • Sastre-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 34619171 ↗
  • Tomova, 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 29128621 ↗
  • Posner 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 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2025 (actual). Primary completion is estimated for Jun 2027, 24 months after the start.

Of 281 non-industry interventional studies with no phase under Suicidal Ideation, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 24 months is below that.

Counting every sponsor, half of 290 studies reached it within 29 months; a quarter within 13 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 25, 2025
First posted
Apr 10, 2025
StartActual
Jun 26, 2025
Primary completionEst.
Jun 26, 2027
CompletionEst.
Jun 26, 2027
Last update
Oct 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: identifiers and verification date
1 update, last Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Minor edits only
    + 2 other changes: identifiers and verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06921226
Lead sponsor
Centre Hospitalier Metropole Savoie
Collaborators
Centre Hospitalier Spécialisé de la Savoie (Chambéry), Université Savoie Mont Blanc
Responsible party
Sponsor
First posted
Apr 10, 2025
Start date
Jun 26, 2025
Primary completion
Jun 26, 2027 (estimated)
Completion
Jun 26, 2027 (estimated)
Last update
Oct 7, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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