Assessment of Dissociative Traumatic Disorders | NCT04379648

Studies
Assessment of Dissociative Traumatic Disorders

NCT04379648

Sponsor

Januel

Status

Unknown status

Last Update Posted

May 7, 2020Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Posttraumatic Stress Disorder

Interventions

self-assessment and hetero-assessment

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 5, 2019Actual

Primary Completion Date

Sep 5, 2020Estimated

Completion Date

Sep 5, 2021Estimated

First Submitted Date

Apr 29, 2020

First Submission Date that Met QC Criteria

May 6, 2020

First Posted Date

May 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2020

Last Update Posted Date

May 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

More than 70% of ambulatory patients with IDD have attempted suicide (APA, 2015). This disorder, as well as all the disorders on the dissociation spectrum, must therefore be clarified and better diagnosed.

The goal of this research is :

to assess the prevalence of dissociative disorders using specific tools in patients suffering from PTSD.
to validate the French version of the DDIS interview (Ross, 1997) that the investigators have translated.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Posttraumatic stress disorder	Other	cohort of patients with Posttraumatic stress disorder PTSD	Other: self-assessment and hetero-assessment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
self-assessment and hetero-assessment	Other	Self assessment for the passing of the following rating scales CTQ-SF36-ITQ-PCL5-DES Hetero-assessment for the pasing of the following rating scales DDIS FR and medical interview

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post Traumatic Stress	assessment of the prevalence of dissociative disorders in a cohort of patients with PTSD	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient diagnosed with PTSD according to DSM 5 criteria
Over 18 years of age
Informed consent signed

Exclusion Criteria:

Neurological disorders
Serious and/or unstable somatic pathologies
Patient not affiliated with social security
Patient hospitalized under restraint in psychiatric care by decision of the state representative or in psychiatric care at the request of a third party
Patient under guardianship
Patient participating in parallel in another biomedical research
Change of antidepressant in the last three months
Patient not mastering the French language

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
BENCHERIF Youcef, CRA	Contact	0143093030		y.bencherif@epsve.fr
Rusheenthira THAVASEELAN, CRA	Contact	0143093030		r.thavaseelan@epsve.fr

Overall Officials

Name	Affiliation	Role
Khalid KALALOU, Psychiatrist	EPS Ville Evrard	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Youcef BENCHERIF	Recruiting	Neuilly-sur-Marne	Île-de-France Region	93330	France

Condition Browse Module

MeSH Terms

ID	Term
D013313	Stress Disorders, Post-Traumatic

Ancestor Terms

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059026	Diagnostic Self Evaluation

Ancestor Terms

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

All patients with a diagnosis of Post Traumatic Stress Disorder will be seen by a physician psychiatrist or psychologist who will introduce them to the study. They will be given an information letter and a consent form. If patients agree to participate in the study, and after signing the consent form, they will be included and will complete the assessment scales.