- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05020197
Study of the Association Between the Type of Attachment and the Risk of Post-Traumatic Stress Disorder (TRAUMAFFECT)
November 21, 2024 updated by: Hospices Civils de Lyon
Study of the Association Between the Type of Attachment and the Risk of Post-Traumatic Stress Disorder: A Prospective Cohort Study in the Forensic Medicine Department of the Hospices Civils de Lyon
Attachment theory models the emotional bonding that is activated in situations of danger, via mental representations of self and others.
Four types of attachment (TA) exist in adults: 3 insecure (Preoccupied, Detached, Fearful) and 1 secure.
Attachment type is a major factor in the development of Post-Traumatic Stress Disorder (PTSD), a frequent and disabling mental disorder that occurs after a traumatic event.
A meta-analysis based on Anglo-Saxon studies including various populations (general, military or clinical) (n=9268 patients) suggested an association between Fearful BP and high level of PTSD symptoms (r=0.44).
Nevertheless, these results did not allow the identification of variations related to the individual risk factors (RDFs) of the subject and his environment, especially in the French socio-cultural context.
The investigators propose to study the association between LDs and the risk of PTSD in the days following exposure, their mutual influence in the months following, and their associated factors.
Thus, a prospective cohort study among French adult victims of a traumatic event could objectify the link between BP - as close as possible to the event - and the risk of PTSD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
268
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lyon, France, 69003
- Service de médecine et santé au travail des HCL
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Having experienced a Potentially Traumatic Event within 3 days and according to DSM5 criterion A: Exposure to actual or potential death, serious injury, or sexual violence in one (or more) of the following ways: Directly experiencing the traumatic event, witnessing the event in person by others, learning that the traumatic event (violent or accidental) was experienced by a close family member or friend, experiencing repeated or extreme exposure to the harrowing details of the traumatic event (e.g., first responders or police officers) (exposure through electronic media, television, films, or photographs, if the exposure is work-related)
Description
Inclusion Criteria:
- Major patient
- Having experienced a Potentially Traumatic Event within 3 days and according to DSM5 criterion A: Exposure to actual or potential death, serious injury, or sexual violence in one (or more) of the following ways: Directly experiencing the traumatic event, witnessing the event in person by others, learning that the traumatic event (violent or accidental) was experienced by a close family member or friend, experiencing repeated or extreme exposure to the harrowing details of the traumatic event (e.g., first responders or police officers) (exposure through electronic media, television, films, or photographs, if the exposure is work-related)
- Good understanding of oral and written French
- Having given written consent
- Patient affiliated to a social security scheme
Exclusion Criteria:
- Psychiatric pathology with current clinical instability (agitation, maladaptive consciousness...) or patient unable to understand questionnaires
- Vulnerable adult (curatorship, guardianship)
- Non French resident
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Experiences in Close Relationships-Revised (ECR-R) attachment questionnaire
Time Frame: Day 30
|
Type of attachment Disorder will be measured at inclusion by the ECR-R attachment questionnaire.
Each item is rated on a 7-point scale where 1 = strongly disagree and 7 = strongly agree.
|
Day 30
|
|
Questionnaire Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time Frame: Day 30
|
Risk of developing Post Traumatic Stress Disorder.
Items are rated on a 5 point scale.
The maximum score is 80.
|
Day 30
|
|
Correlation between Questionnaire PCL-5 AND ECR-R attachment questionnaire
Time Frame: Day 30
|
Correlation of outcome 1 and outcome 2
|
Day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Questionnaire Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time Frame: Day 90
|
Risk of Post-Traumatic Stress Disorder at 90 days.
Items are rated on a 5 point scale.
The maximum score is 80.
|
Day 90
|
|
Questionnaire Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time Frame: Day 90
|
Type of attachment.
Items are rated on a 5 point scale.
The maximum score is 80.
|
Day 90
|
|
Correlation between PCL-5 questionnaire.And PCL-5 questionnaire.at D90
Time Frame: Day 90
|
Correlation between the type of attachment and the risk of Post-Traumatic Stress Disorder
|
Day 90
|
|
Relationship Scales Questionnaire (RSQ)
Time Frame: Day 3
|
30-item self-questionnaire that categorizes participants into four categories of attachment (secure or autonomous, avoiding or detached, preoccupied or ambivalent, fearful or disorganized)
|
Day 3
|
|
Relationship Scales Questionnaire (RSQ)
Time Frame: Day 30
|
30-item self-questionnaire that categorizes participants into four categories of attachment (secure or autonomous, avoiding or detached, preoccupied or ambivalent, fearful or disorganized)
|
Day 30
|
|
Relationship Scales Questionnaire (RSQ)
Time Frame: Day 90
|
Measure of Psychometric performance; 30-item self-questionnaire that categorizes participants into four categories of attachment (secure or autonomous, avoiding or detached, preoccupied or ambivalent, fearful or disorganized)
|
Day 90
|
|
Experiences in Close Relationships-Revised (ECR-R) attachment questionnaire
Time Frame: Day 3
|
Attachment Type.
Each item is rated on a 7-point scale where 1 = strongly disagree and 7 = strongly agree
|
Day 3
|
|
Experiences in Close Relationships-Revised (ECR-R) attachment questionnaire
Time Frame: Day 30
|
Attachment Type.
Each item is rated on a 7-point scale where 1 = strongly disagree and 7 = strongly agree
|
Day 30
|
|
Experiences in Close Relationships-Revised (ECR-R) attachment questionnaire
Time Frame: Day 90
|
Attachment Type.
Each item is rated on a 7-point scale where 1 = strongly disagree and 7 = strongly agree
|
Day 90
|
|
Questionnaire Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time Frame: Day 90
|
Risk of Post Traumatic Stress Disorder (D90).
Items are rated on a 5 point scale.
The maximum score is 80.
|
Day 90
|
|
Impact of Event Scale Revised
Time Frame: Day 3
|
The IES-R consists of a list of 22 symptoms of PTSD.
The person indicates the intensity with which each symptom has manifested itself over the past 7 days, by self-reporting their response on a 5-point Lykert-type scale, ranging from 0 ("Not at all") to 4 ( "Extremely").
The total IES-R score is calculated by adding the values obtained for the 22 items (scores 0-88).
|
Day 3
|
|
Relationship Scales Questionnaire (RSQ)
Time Frame: Day 90
|
30-item self-questionnaire that categorizes participants into four categories of attachment (secure or autonomous, avoiding or detached, preoccupied or ambivalent, fearful or disorganized)
|
Day 90
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ludivine NOHALES, MD, Service de médecine et santé au travail des HCL
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 23, 2022
Primary Completion (Actual)
November 7, 2024
Study Completion (Actual)
November 7, 2024
Study Registration Dates
First Submitted
July 19, 2021
First Submitted That Met QC Criteria
August 19, 2021
First Posted (Actual)
August 25, 2021
Study Record Updates
Last Update Posted (Estimated)
November 25, 2024
Last Update Submitted That Met QC Criteria
November 21, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL20_0814
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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