Study of the Association Between the Type of Attachment and the Risk of Post-Traumatic Stress Disorder

Post-Traumatic Stress Disorder Clinical Trial

— TRAUMAFFECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05020197
• Other study ID #: 69HCL20_0814
• Status: Recruiting
• Start date: March 23, 2022
• Est. completion date: December 23, 2024

Study information

• Verified date: October 2023
• Source: Hospices Civils de Lyon
• Contact: Ludivine NOHALES, MD
• Phone: 04 72 11 01 17
• Email: ludivine.nohales[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 23, 2024
• Est. primary completion date: December 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Diagnostic Test:
• self-questionnaires on attachment and PTSD
The questionnaires (attachement type, PTSD symptoms) are administered face to face at the inclusion visit (at D0-D3). Validated self-questionnaires in French will be sent to the patients, either electronically or by post, according to their choice at D30 and D90. To describe the characteristics of the subjects, socio-demographic data, lifestyle, and medical history will be collected. The questionnaires will be administered three times to study the evolution of the parameters over time.

Locations

Country	Name	City	State
France	Service de médecine et santé au travail des HCL	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Experiences in Close Relationships-Revised (ECR-R) attachment questionnaire	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
Primary	Questionnaire Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)	Risk of developing Post Traumatic Stress Disorder. Items are rated on a 5 point scale. The maximum score is 80.	Day 30
Primary	Correlation between Questionnaire PCL-5 AND ECR-R attachment questionnaire	Correlation of outcome 1 and outcome 2	Day 30
Secondary	Questionnaire Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)	Risk of Post-Traumatic Stress Disorder at 90 days. Items are rated on a 5 point scale. The maximum score is 80.	Day 90
Secondary	Questionnaire Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)	Type of attachment. Items are rated on a 5 point scale. The maximum score is 80.	Day 90
Secondary	Correlation between PCL-5 questionnaire.And PCL-5 questionnaire.at D90	Correlation between the type of attachment and the risk of Post-Traumatic Stress Disorder	Day 90
Secondary	Relationship Scales Questionnaire (RSQ)	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
Secondary	Relationship Scales Questionnaire (RSQ)	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
Secondary	Relationship Scales Questionnaire (RSQ)	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
Secondary	Experiences in Close Relationships-Revised (ECR-R) attachment questionnaire	Attachment Type. Each item is rated on a 7-point scale where 1 = strongly disagree and 7 = strongly agree	Day 3
Secondary	Experiences in Close Relationships-Revised (ECR-R) attachment questionnaire	Attachment Type. Each item is rated on a 7-point scale where 1 = strongly disagree and 7 = strongly agree	Day 30
Secondary	Experiences in Close Relationships-Revised (ECR-R) attachment questionnaire	Attachment Type. Each item is rated on a 7-point scale where 1 = strongly disagree and 7 = strongly agree	Day 90
Secondary	Questionnaire Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)	Risk of Post Traumatic Stress Disorder (D90). Items are rated on a 5 point scale. The maximum score is 80.	Day 90
Secondary	Impact of Event Scale Revised	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
Secondary	Relationship Scales Questionnaire (RSQ)	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