NCT05026450

Brief Summary

The study will seek to explore the possibility of developing post-traumatic stress disorder following a violent offense commited, among the population of prisoners of the Bordeaux-Gradignan penitentiary center.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 17, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

March 21, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

August 17, 2021

Last Update Submit

June 17, 2024

Conditions

Post Traumatic Stress DisorderOffensive AggressionViolent Behavior

Outcome Measures

Primary Outcomes (1)

  • Explore whether Post-Traumatic Stress Disorder develops as a result of a violent act committed.

    Evaluation of Post-traumatic stress disorder using the PTSD self-report scale: PCL-5, with a cut-off value of 38 to indicate the presence of a diagnosis of PTSD.

    1 month

Secondary Outcomes (3)

  • Identify risk factors that may have contributed to the onset of symptoms of post-traumatic stress disorder

    Baseline

  • Identify risk factors that may have contributed to the maintenance of symptoms of post-traumatic stress disorder

    1 month

  • Frequency of post-traumatic stress disorder according to the various factors that may have contributed to its onset

    1 month

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Prisoners incarcerated in the Bordeaux-Gradignan penitentiary center.

You may qualify if:

  • Aged over 18
  • Have as a reason for imprisonment one of the following: Homicide and willful violence resulting in death, Rape or sexual assault, Violence and other personal injury.
  • Having signed and duly completed the Non-Objection form for participation in the study
  • Mastery of the French language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Charles PERRENS

Bordeaux, 33076, France

Location

Related Publications (6)

  • Koenen KC, Ratanatharathorn A, Ng L, McLaughlin KA, Bromet EJ, Stein DJ, Karam EG, Meron Ruscio A, Benjet C, Scott K, Atwoli L, Petukhova M, Lim CCW, Aguilar-Gaxiola S, Al-Hamzawi A, Alonso J, Bunting B, Ciutan M, de Girolamo G, Degenhardt L, Gureje O, Haro JM, Huang Y, Kawakami N, Lee S, Navarro-Mateu F, Pennell BE, Piazza M, Sampson N, Ten Have M, Torres Y, Viana MC, Williams D, Xavier M, Kessler RC. Posttraumatic stress disorder in the World Mental Health Surveys. Psychol Med. 2017 Oct;47(13):2260-2274. doi: 10.1017/S0033291717000708. Epub 2017 Apr 7.

    PMID: 28385165BACKGROUND

  • Baranyi G, Cassidy M, Fazel S, Priebe S, Mundt AP. Prevalence of Posttraumatic Stress Disorder in Prisoners. Epidemiol Rev. 2018 Jun 1;40(1):134-145. doi: 10.1093/epirev/mxx015.

    PMID: 29596582BACKGROUND

  • Fazel S, Baillargeon J. The health of prisoners. Lancet. 2011 Mar 12;377(9769):956-65. doi: 10.1016/S0140-6736(10)61053-7. Epub 2010 Nov 18.

    PMID: 21093904BACKGROUND

  • Ashbaugh AR, Houle-Johnson S, Herbert C, El-Hage W, Brunet A. Psychometric Validation of the English and French Versions of the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). PLoS One. 2016 Oct 10;11(10):e0161645. doi: 10.1371/journal.pone.0161645. eCollection 2016.

    PMID: 27723815BACKGROUND

  • Jakobowitz S, Bebbington P, McKenzie N, Iveson R, Duffield G, Kerr M, Killaspy H. Assessing needs for psychiatric treatment in prisoners: 2. Met and unmet need. Soc Psychiatry Psychiatr Epidemiol. 2017 Feb;52(2):231-240. doi: 10.1007/s00127-016-1313-5. Epub 2016 Nov 22.

    PMID: 27878323BACKGROUND

  • Vaiva G, Jehel L, Cottencin O, Ducrocq F, Duchet C, Omnes C, Genest P, Rouillon F, Roelandt JL. [Prevalence of trauma-related disorders in the French WHO study: Sante mentale en population generale (SMPG)]. Encephale. 2008 Dec;34(6):577-83. doi: 10.1016/j.encep.2007.11.006. Epub 2008 Apr 2. French.

    PMID: 19081454BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Severine BEAUVAIS, MD

    CH CharlesPerrens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2021

First Posted

August 30, 2021

Study Start

March 21, 2022

Primary Completion

May 30, 2022

Study Completion

September 30, 2022

Last Updated

June 18, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

no IPD sharing plan

Locations

FR(1)