Stroke complicAtions After TraUmatic expeRieNces and Stress (SATURN)
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|ClinicalTrials.gov Identifier: NCT03496480|
Recruitment Status : Completed
First Posted : April 12, 2018
Last Update Posted : August 22, 2019
|Condition or disease||Intervention/treatment|
|Stroke||Diagnostic Test: Questionnaires|
Neuropsychiatric consequences of brain ischemia play a critical role in shaping long-term stroke outcome. Unfortunately, however, as of now, clinical research and clinical practice have not adequately addressed this growing challenge. A good case in point is posttraumatic stress disorder (PTSD). Previous trauma exposure and posttraumatic stress symptoms may increase the risk of cardiovascular events (Sumner et al., 2015). Moreover, unbeknownst to most clinical neurologists, a significant portion (approximately 25%) of their stroke patients develop symptoms of post-traumatic stress disorder (PTSD) within the first year post-event. PTSD-related symptoms after an acute coronary syndrome increase the risk of recurrent cardiac events and mortality (Edmondson et al., 2012). Similarly, stroke-induced PTSD has been linked with worse long term stroke outcome, in particular, recurrent stroke, greater disability, non-adherence to medications, and comorbidities (Goldfinger et al., 2014; Kronish et al., 2012).
For a period of 22 months, all stroke patients treated at the Charité Medical Center will be screened retrospectively 9-13 months after a first-ever ischemic stroke (~2000). All eligible patients will be contacted by mail 9-13 months after their hospital stay with the request that they complete the questionnaires. The mailing will also include an information statement, the consent form, as well as a stamped return envelope.
|Study Type :||Observational|
|Actual Enrollment :||636 participants|
|Official Title:||Stroke complicAtions After TraUmatic expeRieNces and Stress - a Retrospective Cohort Study|
|Actual Study Start Date :||April 15, 2018|
|Actual Primary Completion Date :||February 1, 2019|
|Actual Study Completion Date :||July 1, 2019|
- Diagnostic Test: Questionnaires
Psychological questionnaires: BTQ, IES-R, 7-items-short Screening scale, BDI, SF-36
- Stroke-induced PTSD [ Time Frame: 9-13 months after stroke ]Stroke-induced PTSD will be measured using the Impact of Event Scale - Revised (IES-R).
- Trauma exposure [ Time Frame: 9-13 months after stroke ]Prior trauma exposure before the infarct is ascertained with the 10-item Brief Trauma Questionnaire (BTQ).
- Lifetime PTSD [ Time Frame: 9-13 months after stroke ]The occurrence of PTSD symptoms in the study subjects' lifetimes is assessed using the 7-item Short Screening Scale for DSM IV PTSD.
- Functional outcome [ Time Frame: 9-13 months after stroke ]Functional outcome is measured with the SF-36
- Depression [ Time Frame: 9-13 months after stroke ]depressive symptoms are assessed with the BDI (Beck's Depression Inventory)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496480
|Charité Universitätsmedizin Berlin|
|Berlin, Germany, 10117|