Stroke complicAtions After TraUmatic expeRieNces and Stress

Completed

• Conditions: Stroke

• Registration Number: NCT03496480
• Lead Sponsor: Johanna Schöner

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-04-05
• Study First Posted: 2018-04-12
• Study Start: 2018-04-15
• Primary Completion: 2019-02-01
• Study Completion: 2019-07-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-21
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 636

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stroke-induced PTSD	9-13 months after stroke	Stroke-induced PTSD will be measured using the Impact of Event Scale - Revised (IES-R).

Secondary Outcome Measures

Name	Time	Method
Trauma exposure	9-13 months after stroke	Prior trauma exposure before the infarct is ascertained with the 10-item Brief Trauma Questionnaire (BTQ).
Lifetime PTSD	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	9-13 months after stroke	Functional outcome is measured with the SF-36

Trial Locations

Locations (1)

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany