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

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05020197
Collaborator
(none)
500
21

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: self-questionnaires on attachment and PTSD

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Experiences in Close Relationships-Revised (ECR-R) attachment questionnaire [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.

  2. Questionnaire Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) [Day 30]

    Risk of developing Post Traumatic Stress Disorder. Items are rated on a 5 point scale. The maximum score is 80.

  3. Correlation between Questionnaire PCL-5 AND ECR-R attachment questionnaire [Day 30]

    Correlation of outcome 1 and outcome 2

Secondary Outcome Measures

  1. Questionnaire Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) [Day 90]

    Risk of Post-Traumatic Stress Disorder at 90 days. Items are rated on a 5 point scale. The maximum score is 80.

  2. Questionnaire Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) [Day 90]

    Type of attachment. Items are rated on a 5 point scale. The maximum score is 80.

  3. Correlation between PCL-5 questionnaire.And PCL-5 questionnaire.at D90 [Day 90]

    Correlation between the type of attachment and the risk of Post-Traumatic Stress Disorder

  4. Relationship Scales Questionnaire (RSQ) [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)

  5. Relationship Scales Questionnaire (RSQ) [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)

  6. Relationship Scales Questionnaire (RSQ) [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)

  7. Experiences in Close Relationships-Revised (ECR-R) attachment questionnaire [Day 3]

    Attachment Type. Each item is rated on a 7-point scale where 1 = strongly disagree and 7 = strongly agree

  8. Experiences in Close Relationships-Revised (ECR-R) attachment questionnaire [Day 30]

    Attachment Type. Each item is rated on a 7-point scale where 1 = strongly disagree and 7 = strongly agree

  9. Experiences in Close Relationships-Revised (ECR-R) attachment questionnaire [Day 90]

    Attachment Type. Each item is rated on a 7-point scale where 1 = strongly disagree and 7 = strongly agree

  10. Questionnaire Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) [Day 90]

    Risk of Post Traumatic Stress Disorder (D90). Items are rated on a 5 point scale. The maximum score is 80.

  11. Impact of Event Scale Revised [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).

  12. Relationship Scales Questionnaire (RSQ) [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT05020197
Other Study ID Numbers:
  • 69HCL20_0814
First Posted:
Aug 25, 2021
Last Update Posted:
Aug 25, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2021