Post Traumatic Stress DisorderIPTAVCNCT05026450
Exploring the Psycho-traumatic Impact of a Violent Act Commited at the Bordeaux-Gradignan Penitentiary Center
An observational study of Post Traumatic Stress Disorder and Offensive Aggression, run by Centre Hospitalier Charles Perrens, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder, Offensive Aggression, Violent Behavior
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 21 Mar 2022to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prisoners incarcerated in the Bordeaux-Gradignan penitentiary center.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Psycho-traumatic Impact of a Violent Act Commited - Study Among Inmates of the Bordeaux-Gradignan Penitentiary Center
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.
Read the detailed description
The overrepresentation of psychiatric disorders among prisoners has been the subject of numerous studies and the significant increase in the number of prisoners over the past 3 decades, make research in prisons a major public health issue.
Recent studies have been able to highlight an over-representation of post-traumatic stress disorder in the prison population. Leading to questionning the factors that could explain the overrepresentation of this disorder in prison with various hypotheses raised. Among these hypotheses, the possibility of developing post-traumatic stress disorder following a violent offense commited has been proposed.
The study will thus seek to explore the development of a Post-traumatic Stress Disorder following a violent act committed using the PCL-5 questionnaire
Study design :Observational, descriptive, monocentric study with completion of an anonymous self-questionnaire.
Participation in the study is voluntary and anonymous with signature of a non-opposition form.
Expected outcomes : better knowledge of this disorder in detention and a hypothesis to explain its overrepresentation. Earlier detection of this pathology in prison could thus be considered, in particular by improving the identification of people at risk according to the presence of contributing factors. More specific support and improved access to care for inmates could be considered, allowing early treatment and thus avoiding progression to other co-morbidities or risk of recidivism.
- Medical subject headings
- Stress Disorders, Post-Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (3)
Identify risk factors that may have contributed to the onset of symptoms of post-traumatic stress disorder
Socio-demographic data, personnal and medical history
Measured: Baseline
Identify risk factors that may have contributed to the maintenance of symptoms of post-traumatic stress disorder
Socio-demographic data, personnal and medical history
Measured: 1 month
Frequency of post-traumatic stress disorder according to the various factors that may have contributed to its onset
Age, sex, length of time since the offense, possible link with the victim, history of psychiatric follow-up and history of exposure to other traumatic events
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start21 Mar 2022
- Primary completion30 May 2022
- Study completion30 Sep 2022
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 Post Traumatic Stress DisorderStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Charles Perrens, Bordeaux
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Severine BEAUVAIS, MD, Principal investigator, CH CharlesPerrens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026450
- Sponsor's protocol ID
- 2021-A01298-33
- Acronym
- IPTAVC
- Status last verified
- Jun 2024
- First submitted
- 17 Aug 2021
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no IPD sharing plan
Publications
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.
PubMed 28385165Baranyi 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.
PubMed 29596582Fazel 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.
PubMed 21093904Ashbaugh 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.
PubMed 27723815Jakobowitz 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.
PubMed 27878323Vaiva 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.
PubMed 19081454
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Psycho-traumatic Impact of a Violent Act Commited - Study Among Inmates of the Bordeaux-Gradignan Penitentiary Center
- ClinicalTrials.gov ID
- NCT05026450
- Acronym / sponsor ID
- IPTAVC / 2021-A01298-33
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Centre Hospitalier Charles Perrens, BordeauxOther government
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overrepresentation of psychiatric disorders among prisoners has been the subject of numerous studies and the significant increase in the number of prisoners over the past 3 decades, make research in prisons a major public health issue.
Recent studies have been able to highlight an over-representation of post-traumatic stress disorder in the prison population. Leading to questionning the factors that could explain the overrepresentation of this disorder in prison with various hypotheses raised. Among these hypotheses, the possibility of developing post-traumatic stress disorder following a violent offense commited has been proposed.
The study will thus seek to explore the development of a Post-traumatic Stress Disorder following a violent act committed using the PCL-5 questionnaire
Study design :Observational, descriptive, monocentric study with completion of an anonymous self-questionnaire.
Participation in the study is voluntary and anonymous with signature of a non-opposition form.
Expected outcomes : better knowledge of this disorder in detention and a hypothesis to explain its overrepresentation. Earlier detection of this pathology in prison could thus be considered, in particular by improving the identification of people at risk according to the presence of contributing factors. More specific support and improved access to care for inmates could be considered, allowing early treatment and thus avoiding progression to other co-morbidities or risk of recidivism.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prisoners incarcerated in the Bordeaux-Gradignan penitentiary center.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Explore whether Post-Traumatic Stress Disorder develops as a result of a violent act committed.
Time frame: 1 month
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.
3 secondary outcomes
Identify risk factors that may have contributed to the onset of symptoms of post-traumatic stress disorder
Time frame: Baseline
Identify risk factors that may have contributed to the maintenance of symptoms of post-traumatic stress disorder
Time frame: 1 month
Frequency of post-traumatic stress disorder according to the various factors that may have contributed to its onset
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Background: PubMed 28385165Koenen 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.
- Background: PubMed 29596582Baranyi 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.
- Background: PubMed 21093904Fazel 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.
- Background: PubMed 27723815Ashbaugh 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.
- Background: PubMed 27878323Jakobowitz 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.
- Background: PubMed 19081454Vaiva 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.
- Individual participant dataSharing planned: No. no IPD sharing plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Severine BEAUVAIS, MD principal investigator
CH CharlesPerrens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Traumatic Stress Disorder and Offensive Aggression, run by Centre Hospitalier Charles Perrens, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explore whether Post-Traumatic Stress Disorder develops as a result of a violent act committed. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05026450, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.