NCT05020197

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
268

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

March 23, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2024

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

2.6 years

First QC Date

July 19, 2021

Last Update Submit

November 21, 2024

Conditions

Keywords

AttachmentPTSDrisk factor

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Correlation between Questionnaire PCL-5 AND ECR-R attachment questionnaire

    Correlation of outcome 1 and outcome 2

    Day 30

Secondary Outcomes (12)

  • Questionnaire Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

    Day 90

  • Questionnaire Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

    Day 90

  • Correlation between PCL-5 questionnaire.And PCL-5 questionnaire.at D90

    Day 90

  • Relationship Scales Questionnaire (RSQ)

    Day 3

  • Relationship Scales Questionnaire (RSQ)

    Day 30

  • +7 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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

You may not qualify if:

  • Psychiatric pathology with current clinical instability (agitation, maladaptive consciousness...) or patient unable to understand questionnaires
  • Vulnerable adult (curatorship, guardianship)
  • Non French resident

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de médecine et santé au travail des HCL

Lyon, 69003, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Ludivine NOHALES, MD

    Service de médecine et santé au travail des HCL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2021

First Posted

August 25, 2021

Study Start

March 23, 2022

Primary Completion

November 7, 2024

Study Completion

November 7, 2024

Last Updated

November 25, 2024

Record last verified: 2024-11

Locations