NCT06921226

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Apr 2025Apr 2027

First Submitted

Initial submission to the registry

March 25, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2027

Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

March 25, 2025

Last Update Submit

April 8, 2025

Conditions

Keywords

Risk-taking behaviorsImpulsivityInterpersonal needsSuicidal ruminationsSuicidal behaviorsBART

Outcome Measures

Primary Outcomes (1)

  • Suicidal ideation and behaviors

    C-SSRS score (screen version) out of 6

    At inclusion

Study Arms (1)

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)

Other: Psychological ProcessesOther: Risk-taking variablesOther: Suicidal ideation and behavior

Interventions

* 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.

Procedure based on questionnaires and a computer task

* 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.

Procedure based on questionnaires and a computer task

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.

Procedure based on questionnaires and a computer task

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CH Métropole Savoie

Chambéry, Savoie, 73011, France

Location

Centre Hospitalier Spécialisé de la Savoie (CHS)

Bassens, 73000, France

Location

ESPOIR73

Francin, 73800, France

Location

Related Publications (6)

  • 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.

    PMID: 31195164BACKGROUND
  • 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.

    PMID: 33812323BACKGROUND
  • 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.

    PMID: 34619171BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 29128621BACKGROUND
  • 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.

    PMID: 22193671BACKGROUND

MeSH Terms

Conditions

Suicidal IdeationRisk-TakingImpulsive Behavior

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 10, 2025

Study Start

April 15, 2025

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

April 15, 2027

Last Updated

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations