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Completed

NCT Number: NCT05020197

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

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.

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Key information

Conditions

Post-traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de médecine et santé au travail des HCL

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

self-questionnaires on attachment and PTSD

Diagnostic Test

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.

Primary outcomes

  1. 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.

  2. 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.

  3. Correlation between Questionnaire PCL-5 AND ECR-R attachment questionnaire

    Time frame: Day 30

    Correlation of outcome 1 and outcome 2

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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)

  5. 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)

  6. 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)

  7. 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

  8. 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

  9. 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

  10. 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.

  11. 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).

  12. 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)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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

Acronym: TRAUMAFFECT

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 25, 2021
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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