- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05070962
Complex Post-traumatic Stress Disorder: What Symptomatological Specificities (StuCoTra)
September 27, 2021 updated by: Raincy Montfermeil Hospital Group
A better understanding of the Complex Post-Traumatic Stress Disorder would allow a management as close as possible to the specificities of this one, but also a better training of professionals and adapted therapeutic indications.
Study Overview
Detailed Description
Post-Traumatic Stress Disorder manifests itself in a multitude of symptoms and self-regulation difficulties in various domains (somatization and biological balance, attention and consciousness, regulation of affects and impulses, interpersonal relationships and relational capacities, perception of the aggressor and of the aggression, self-perception and identity, sense and belief system) as well as profound changes in personality and various comorbidities .In addition, dissociation, the origin and the resulting disorders also have some similarities to Complex Post-Traumatic Stress Disorder.
Indeed, dissociation is thought to have a traumatic origin and the symptomatology (eg hyperesthesia, dissociative amnesia, anesthesia) is included in Complex Post-Traumatic Stress Disorder.
We can then ask ourselves the following questions: is Complex Post-Traumatic Stress Disorder a dissociative disorder in its own right causing difficulties with self-regulation?
What is the share of dissociation in Complex Post-Traumatic Stress Disorder?
Study Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marion SIMION
- Phone Number: + 33 6 76 25 00 26
- Email: oriane.simion.etu@univ-lille.fr
Study Contact Backup
- Name: Stéphane RUSINEK, Pr
- Phone Number: +33 3 20 41 67 87
- Email: stephane.rusinek@univ-lille.fr
Study Locations
-
-
-
Aulnay-sous-Bois, France, 93 600
- Recruiting
- USAP CHI Robert Ballanger Boulevard Robert Ballanger
-
Contact:
- Marion SIMION
- Email: oriane.simion.etu@univ-lille.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The clinical population is made up of individuals who are victims of repeated trauma and are cared for in specialized centers; The general reference population is made up of volunteer students from the University of Lille.
Description
Inclusion Criteria:
For clinical population;
- Age between 18 and 65 years old;
- Having experienced repeated and prolonged traumatic exposure;
- Able to understand and answer self-questionnaires;
- Having expressed their free and informed consent
- Affiliated with a social security scheme
For general population:
- Student volunteers from the University of Lille;
- Aged between 18 and 65 years old;
- Able to understand and answer self-questionnaires;
- Having expressed their free and informed consent.
Exclusion Criteria:
For clinical population;
- People with difficulties in answering the self-questionnaires (e.g. incomprehension of items, emotional difficulties);
- Persons under tutorship or curatorship;
- Persons deprived of their liberty.
For general population:
- People with difficulties in answering the self-questionnaires (e.g. incomprehension of items, emotional difficulties);
- Persons under tutorship or curatorship;
- Persons deprived of their liberty;
- Persons having a link of subordination with the investigative team.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Clinical population
having experienced repeated and prolonged traumatic exposure
|
or the general population, students of the University of Lille will be offered the opportunity to participate in a study through posters in the corridors of the faculties and announcements in the lecture halls.
Other Names:
|
General population
Student volunteers from the University of Lille
|
or the general population, students of the University of Lille will be offered the opportunity to participate in a study through posters in the corridors of the faculties and announcements in the lecture halls.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the symptomatological characteristics of Complex Post-Traumatic Stress Disorder
Time Frame: during the study
|
to evaluate the symptomatic characteristics of TSPTc evoked by the authors (cognitions, emotional regulation, comorbidities, etc.) in order to better identify the symptomatic specificities of the disorder and improve its management.
|
during the study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Validation of the French version of two self-assessment scales;
Time Frame: during the study
|
Validate the French-language version of two TSPTc self-assessment scales (SIDES-SR and ITQ) on a French population;
|
during the study
|
differences in self-assessment of the participant's overall functioning and personality
Time Frame: during the study
|
differences in participant's general functioning and personality self-assessment between tCPD and personality disorders - specifically Borderline Personality Disorder (BPD).
|
during the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marion SIMION, USAP CHI Robert Ballanger
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 17, 2021
Primary Completion (Anticipated)
February 1, 2023
Study Completion (Anticipated)
February 1, 2023
Study Registration Dates
First Submitted
September 14, 2021
First Submitted That Met QC Criteria
September 27, 2021
First Posted (Actual)
October 7, 2021
Study Record Updates
Last Update Posted (Actual)
October 7, 2021
Last Update Submitted That Met QC Criteria
September 27, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GHT_ CHIRB -RIPH2_003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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