Back to resultsAssessment of Dissociative Traumatic Disorders (TEDI)
Primary Purpose
Posttraumatic Stress Disorder
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
self-assessment and hetero-assessment
Sponsored by
About this trial
This is an interventional other trial for Posttraumatic Stress Disorder
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
Sites / Locations
- Youcef BENCHERIFRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Posttraumatic stress disorder
Arm Description
cohort of patients with Posttraumatic stress disorder PTSD
Outcomes
Primary Outcome Measures
Post Traumatic Stress
assessment of the prevalence of dissociative disorders in a cohort of patients with PTSD
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04379648
Brief Title
Assessment of Dissociative Traumatic Disorders
Acronym
TEDI
Official Title
Assessment of Dissociative Traumatic Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 5, 2019 (Actual)
Primary Completion Date
September 5, 2020 (Anticipated)
Study Completion Date
September 5, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Januel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Posttraumatic stress disorder
Arm Type
Other
Arm Description
cohort of patients with Posttraumatic stress disorder PTSD
Intervention Type
Other
Intervention Name(s)
self-assessment and hetero-assessment
Intervention Description
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
Primary Outcome Measure Information:
Title
Post Traumatic Stress
Description
assessment of the prevalence of dissociative disorders in a cohort of patients with PTSD
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BENCHERIF Youcef, CRA
Phone
0143093030
Email
y.bencherif@epsve.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Rusheenthira THAVASEELAN, CRA
Phone
0143093030
Email
r.thavaseelan@epsve.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalid KALALOU, Psychiatrist
Organizational Affiliation
EPS Ville Evrard
Official's Role
Principal Investigator
Facility Information:
Facility Name
Youcef BENCHERIF
City
Neuilly Sur Marne
State/Province
Île De France
ZIP/Postal Code
93330
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youcef BENCHERIF, CRA
Phone
0143093030
Email
y.bencherif@epsve.fr
12. IPD Sharing Statement
Learn more about this trial
Assessment of Dissociative Traumatic Disorders
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