Post-Traumatic Stress DisorderTRAUMAFFECTNCT05020197
Study of the Association Between the Type of Attachment and the Risk of Post-Traumatic Stress Disorder
An observational study of Post-Traumatic Stress Disorder, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- self-questionnaires on attachment and PTSD
- How many people
- 268 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2022to 7 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- Psychiatric pathology with current clinical instability (agitation, maladaptive consciousness...) or patient unable to understand questionnaires
- Vulnerable adult (curatorship, guardianship)
- Non French resident
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- self-questionnaires on attachment and PTSD
- Keywords
- Attachment, PTSD, risk factor
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-questionnaires on attachment and PTSDDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 30
Correlation between Questionnaire PCL-5 AND ECR-R attachment questionnaire
Correlation of outcome 1 and outcome 2
Measured: Day 30
Secondary outcomes (12)
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.
Measured: Day 90
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.
Measured: Day 90
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
Measured: Day 90
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)
Measured: Day 3
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)
Measured: Day 30
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)
Measured: Day 90
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
Measured: Day 3
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
Measured: Day 30
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
Measured: Day 90
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.
Measured: Day 90
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).
Measured: Day 3
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)
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start23 Mar 2022
- Primary completion7 Nov 2024
- Study completion7 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ludivine NOHALES, MD, Principal investigator, Service de médecine et santé au travail des HCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020197
- Sponsor's protocol ID
- 69HCL20_0814
- Acronym
- TRAUMAFFECT
- Status last verified
- Nov 2024
- First submitted
- 19 Jul 2021
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05020197
- Acronym / sponsor ID
- TRAUMAFFECT / 69HCL20_0814
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Attachment, PTSD, risk factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 7 Nov 2024 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Psychiatric pathology with current clinical instability (agitation, maladaptive consciousness...) or patient unable to understand questionnaires
- Vulnerable adult (curatorship, guardianship)
- Non French resident
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-questionnaires on attachment and PTSDThe 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. | Diagnostic test | – |
Primary outcome
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.
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.
Correlation between Questionnaire PCL-5 AND ECR-R attachment questionnaire
Time frame: Day 30
Correlation of outcome 1 and outcome 2
12 secondary outcomes
Questionnaire Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time frame: Day 90
Questionnaire Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time frame: Day 90
Correlation between PCL-5 questionnaire.And PCL-5 questionnaire.at D90
Time frame: Day 90
Relationship Scales Questionnaire (RSQ)
Time frame: Day 3
Relationship Scales Questionnaire (RSQ)
Time frame: Day 30
Relationship Scales Questionnaire (RSQ)
Time frame: Day 90
Experiences in Close Relationships-Revised (ECR-R) attachment questionnaire
Time frame: Day 3
Experiences in Close Relationships-Revised (ECR-R) attachment questionnaire
Time frame: Day 30
Experiences in Close Relationships-Revised (ECR-R) attachment questionnaire
Time frame: Day 90
Questionnaire Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time frame: Day 90
Impact of Event Scale Revised
Time frame: Day 3
Relationship Scales Questionnaire (RSQ)
Time frame: Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ludivine NOHALES, MD principal investigator
Service de médecine et santé au travail des HCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Traumatic Stress Disorder, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experiences in Close Relationships-Revised (ECR-R) attachment questionnaire (time frame: Day 30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.