Observational Study of the Evaluation of Post Traumatic Stress Post Stroke (SPTD)

Stress Disorder Post-stroke: Observational Study of the Evaluation of Post Traumatic Stress Post Stroke (Stroke Post Traumatic Disorder)

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.

Study Overview

• Status: Withdrawn
• Conditions: Post Traumatic Stress Disorder

• Study Type: Observational

Contacts and Locations

Study Locations

• France
  • Dax, France, 40100
    • Centre Hospitalier Dax

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the number of patients managed for stroke and presenting Stroke Post Traumatic Disorder at 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.	at time of inclusion (3 months after stroke)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the number of patients managed for stroke and presenting Stroke Post Traumatic Disorder at 3 and at 6 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.	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 presenting a depressive state at 3 months	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.	at time of inclusion (3 months after stroke)
Evaluate the number of patients under antidepressant or anxiolytics treatment before the 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.	at time of inclusion (3 months after stroke)
Evaluate the PCL-5 questionnaire as a screening tool of the stroke post traumatic disorder	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.	at time of inclusion (3 months after stroke) and 6 months after stroke (study participation duration for patient: 3 months)
Evaluate the traumatic history of the patient before the occurrence of the 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).	at time of inclusion (3 months after stroke)
Evaluate the existence of a peritraumatic dissociation at the time of the occurrence of the 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).	at time of inclusion (3 months after stroke)

Collaborators and Investigators

• Sponsor: Ch Mont de Marsan
• Investigators: Principal Investigator: Harold PERDIGNON, CH de Dax; Study Director: Francine CLEMENTI, MD, CH de Dax

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Stroke; PCL 5
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2019-A01962-55

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No