Charité Universitätsmedizin Berlin
Berlin, 10117, Germany
NCT Number: NCT03496480
The primary aim of this retrospective cohort study is to test the hypothesis that previous traumatization (long) before an ischemic stroke increases the degree of stroke-induced PTSD symptoms at 9-13 months after the stroke event. Secondary outcome parameters include quality of life and depression.
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Notify Me18 year and older
All sexes
Observational
Berlin, 10117, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Psychological questionnaires: BTQ, IES-R, 7-items-short Screening scale, BDI, SF-36
Time frame: 9-13 months after stroke
Stroke-induced PTSD will be measured using the Impact of Event Scale - Revised (IES-R).
Time frame: 9-13 months after stroke
Prior trauma exposure before the infarct is ascertained with the 10-item Brief Trauma Questionnaire (BTQ).
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.
Time frame: 9-13 months after stroke
Functional outcome is measured with the SF-36
Time frame: 9-13 months after stroke
depressive symptoms are assessed with the BDI (Beck's Depression Inventory)
Johanna Schöner
Other
Stroke complicAtions After TraUmatic expeRieNces and Stress - a Retrospective Cohort Study
Acronym: SATURN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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