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

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Contact Backup

Study Locations

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
Other: clinical population
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 poupulation
General population
Student volunteers from the University of Lille
Other: clinical population
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 poupulation

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.

Sponsor

Raincy Montfermeil Hospital Group

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

Keywords

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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