NCT05070962

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 7, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

October 7, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

September 14, 2021

Last Update Submit

September 27, 2021

Conditions

Psychiatric Health

Keywords

Disorder,complex post-traumatic stress disorderpersonality disorders

Outcome Measures

Primary Outcomes (1)

  • the symptomatological characteristics of Complex Post-Traumatic Stress Disorder

    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 Outcomes (2)

  • Validation of the French version of two self-assessment scales;

    during the study

  • differences in self-assessment of the participant's overall functioning and personality

    during the study

Study Arms (2)

Clinical population

having experienced repeated and prolonged traumatic exposure

Other: clinical population

General population

Student volunteers from the University of Lille

Other: clinical population

Interventions

clinical populationOTHER

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.

Also known as: general poupulation
Clinical populationGeneral population

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USAP CHI Robert Ballanger Boulevard Robert Ballanger

Aulnay-sous-Bois, 93 600, France

RECRUITING

MeSH Terms

Conditions

DiseasePersonality Disorders

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Marion SIMION

    USAP CHI Robert Ballanger

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion SIMION

CONTACT

+ 33 6 76 25 00 26oriane.simion.etu@univ-lille.fr

Stéphane RUSINEK, Pr

CONTACT

+33 3 20 41 67 87stephane.rusinek@univ-lille.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2021

First Posted

October 7, 2021

Study Start

February 17, 2021

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

October 7, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)