Post Traumatic Stress DisorderSPTDNCT04299841
Observational Study of the Evaluation of Post Traumatic Stress Post Stroke
An observational study of Post Traumatic Stress Disorder, run by CHI MONT DE MARSAN ET PAYS DES SOURCES at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2021to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- PCL 5, Stroke
- Medical subject headings
- Stress Disorders, Post-Traumatic, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at time of inclusion (3 months after stroke)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: at time of inclusion (3 months after stroke)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study startMar 2021 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Why it stopped: lack of time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHI MONT DE MARSAN ET PAYS DES SOURCES
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harold PERDIGNON, Principal investigator, CH de DaxFrancine CLEMENTI, MD, Study director, CH de Dax
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299841
- Sponsor's protocol ID
- 2019-A01962-55
- Acronym
- SPTD
- Status last verified
- Aug 2021
- First submitted
- 5 Mar 2020
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Disorder Post-stroke: Observational Study of the Evaluation of Post Traumatic Stress Post Stroke (Stroke Post Traumatic Disorder)
- ClinicalTrials.gov ID
- NCT04299841
- Acronym / sponsor ID
- SPTD / 2019-A01962-55
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- PCL 5, Stroke
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: lack of time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CHI MONT DE MARSAN ET PAYS DES SOURCESUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the number of patients managed for stroke and presenting Stroke Post Traumatic Disorder at 3 months after stroke
Time frame: 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.
6 secondary outcomes
Evaluate the number of patients managed for stroke and presenting Stroke Post Traumatic Disorder at 3 and at 6 months
Time frame: 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
Time frame: at time of inclusion (3 months after stroke)
Evaluate the number of patients under antidepressant or anxiolytics treatment before the stroke
Time frame: at time of inclusion (3 months after stroke)
Evaluate the PCL-5 questionnaire as a screening tool of the stroke post traumatic disorder
Time frame: 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
Time frame: at time of inclusion (3 months after stroke)
Evaluate the existence of a peritraumatic dissociation at the time of the occurrence of the stroke
Time frame: at time of inclusion (3 months after stroke)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harold PERDIGNON principal investigator
CH de Dax
Francine CLEMENTI, MD study director
CH de Dax
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Traumatic Stress Disorder, run by CHI MONT DE MARSAN ET PAYS DES SOURCES at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the number of patients managed for stroke and presenting Stroke Post Traumatic Disorder at 3 months after stroke (time frame: at time of inclusion (3 months after stroke)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.