SPTD: Observational Study of the Evaluation of Post Traumatic Stress Post Stroke

Sponsor
Ch Mont de Marsan (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04299841
Collaborator
(none)
0
1
9
0

Study Details

Study Description

Brief Summary

This prospective, observational, multicentre study evaluates the existence of Post-traumatic stress disorder following a stroke at 3 and 6 months after the management of the patient.

Questionnaires will be used to assess the presence of stroke post traumatic disorder.

The evaluation of stroke post traumatic disorder would allow to underline the importance of the awareness of the care teams in the the screening of these disorders and to evaluate if the Post-traumatic Stress Disorder Checklist Scale (PCL5) is an effective screening tool.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Stress Disorder Post-stroke: Observational Study of the Evaluation of Post Traumatic Stress Post Stroke (Stroke Post Traumatic Disorder)
    Anticipated Study Start Date :
    Mar 1, 2021
    Anticipated Primary Completion Date :
    Oct 1, 2021
    Anticipated Study Completion Date :
    Dec 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate the number of patients managed for stroke and presenting Stroke Post Traumatic Disorder at 3 months after stroke [at time of inclusion (3 months after stroke)]

      Evaluate the number of patients managed for stroke and presenting Stroke Post Traumatic Disorder at 3 months after stroke. This evaluation will be made by completion of PCL-5 questionnaire (Post-traumatic stress disorder checklist version DSM-5 (DSM:Diagnostic and Statistical Manuel of Mental Disorders)). A PCL-5 positive score will be an indicator of post-traumatic stress disorder correlated with stroke.

    Secondary Outcome Measures

    1. Evaluate the number of patients managed for stroke and presenting Stroke Post Traumatic Disorder at 3 and at 6 months [at time of inclusion (3 months after stroke) and 6 months after stroke (study participation duration for patient: 3 months)]

      Evaluate the number of patients managed for stroke and presenting Stroke Post Traumatic Disorder at 3 and at 6 months. This evaluation will be made by completion of PCL-5 questionnaire (Post-traumatic stress disorder checklist version DSM-5). A PCL-5 positive score will be an indicator of post-traumatic stress disorder correlated with stroke. Two timepoint: 3 months and 6 months after stroke.

    2. Evaluate the number of patients presenting a depressive state at 3 months [at time of inclusion (3 months after stroke)]

      Evaluate the number of patients presenting a depressive state at 3 months after stroke. This evaluation was done by completion of HAD (Hospital Anxiety and Depression scale) questionnaire. A score between 8 and 10 will identify a doubtful depressive symptomatology and a score Superior to 11 will identify a certain depressive symptomatology.

    3. Evaluate the number of patients under antidepressant or anxiolytics treatment before the stroke [at time of inclusion (3 months after stroke)]

      The evaluation of the number of patients under antidepressant or anxiolytics treatment before the stroke will be made by the collection of previous treatments of the patient.

    4. Evaluate the PCL-5 questionnaire as a screening tool of the stroke post traumatic disorder [at time of inclusion (3 months after stroke) and 6 months after stroke (study participation duration for patient: 3 months)]

      Evaluate the PCL-5 questionnaire as a screening tool of the stroke post traumatic disorder by completion of PCL-5 questionnaire at two timepoint (3 and 6 months post-stroke). The presence of Post-traumatic Stress Disorder will be defined by threshold value of 38 as the total score on the PCL-5 questionnaire.

    5. Evaluate the traumatic history of the patient before the occurrence of the stroke [at time of inclusion (3 months after stroke)]

      Evaluate the number of patients presenting a depressive state at 3 months after stroke. This evaluation was done by completion of Trauma History Questionnaire (THQ).

    6. Evaluate the existence of a peritraumatic dissociation at the time of the occurrence of the stroke [at time of inclusion (3 months after stroke)]

      Evaluate the number of patients presenting a depressive state at 3 months after stroke. This evaluation was done by completion of PDEQ (Peritraumatic Dissociative Experience Questionnaire).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patient age > 18years old

    • Patient registered with a social security scheme

    • Patient who was given a written information and who gave his/her non-opposition

    • Patient who was hospitalized with a diagnosis of stroke in the neurology department and oriented to the post-stroke consultation (3 months after the hospital discharge) or un the follow-up care and readaptation department of hospital center of Dax or Mont de Marsan

    Exclusion Criteria:
    • Patient with a serious disability sequelae (mRS>3),

    • Patient without enough level of proficiency in the French language,

    • Patient with neurocognitive and neurocognitive disorder diagnosed,

    • Patient with history of significant psychiatric disorders diagnosed,

    • Patient with seve aphasia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 centre hospitalier Dax Dax France 40100

    Sponsors and Collaborators

    • Ch Mont de Marsan

    Investigators

    • Principal Investigator: Harold PERDIGNON, CH de Dax
    • Study Director: Francine CLEMENTI, MD, CH de Dax

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ch Mont de Marsan
    ClinicalTrials.gov Identifier:
    NCT04299841
    Other Study ID Numbers:
    • 2019-A01962-55
    First Posted:
    Mar 9, 2020
    Last Update Posted:
    Aug 20, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ch Mont de Marsan
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 20, 2021