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Physical trauma patients with symptoms of an acute and post-traumatic stress disorder: an observational study


- candidate number26906
- NTR NumberNTR6258
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-mrt-2017
- Secondary IDs80-84200-98-15213, NL55386.028.15 ZonMW project number, CCMO
- Public TitlePhysical trauma patients with symptoms of an acute and post-traumatic stress disorder: an observational study
- Scientific TitlePhysical trauma patients with symptoms of an acute stress disorder: an observational study
- ACRONYMTraP-study
- hypothesisThe aim is to examine the natural course of Acute Stress Disorder (ASD) symptoms (aim 1) and the effects of these symptoms on the development of Port-Traumatic Stress Disorder (PTSD) and patientsí» psychological distress (i.e., anxiety and depressive symptoms) and Quality of Life (QOL) across time (aim 2) as well as examining whether we can identify a subgroup of patients in whom ASD symptoms remain or increase. This provides valuable insight in the need for a psychological intervention (aim 3) to prevent PTSD.
- Healt Condition(s) or Problem(s) studiedPost-Traumatic Stress Disorder (PTSD), Trauma , Acute stress disorder
- Inclusion criteriaBeing treated in the shock room
Being aged 18 or older
- Exclusion criteriaSevere traumatic brain injury (Glasgow Coma Scale í▄ 8)
Dementia
Insufficient knowledge of the Dutch language (verbal and in writing).
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 5-nov-2016
- planned closingdate1-jan-2019
- Target number of participants300
- InterventionsNot applicable
- Primary outcomeIncidence (i.e. new patients with symptoms) of ASD and PTSD and anxiety at one year after treatment for physical trauma
- Secondary outcomePsychological distress
Personality and trait anxiety
Coping
QOL
Medical history (e.g. previously treated in shock room due to physical trauma)
History of psychological and psychiatric disorders
- TimepointsBaseline (almost directly after trauma), 3, 6, 9 and 12 months after treatment for physical trauma
- Trial web siteNot applicable
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc. Eva Visser
- CONTACT for SCIENTIFIC QUERIESPhD. J. Vries, de
- Sponsor/Initiator Elisabeth-Twee Steden ziekenhuis , Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsNot applicable
- Brief summaryType-I-trauma (single traumatic event) can cause severe symptoms of PTSD. ASD has hardly been studied in trauma patients. Therefore, we perform an observational prospective cohort study to examine the natural course of ASD symptoms (aim 1) and the effects of these symptoms on the development of PTSD and patientsí» psychological distress (i.e., anxiety and depressive symptoms) and QOL across time (aim 2) as well as examining whether we can identify a subgroup of patients in whom ASD symptoms remain or increase. This provides valuable insight in the need for a psychological intervention (aim 3) to prevent PTSD. All patients who have been in the shock room of the Elisabeth-TweeSteden hospital and Erasmus Medical Centre during the inclusion period will be asked to participate as soon as they are lucid. The procedure is that when patients agree to participate and sign an informed consent, they will complete a questionnaire assessing ASD symptoms and some socio-demographic questions. The inclusion period will be about 15 months. Participants will complete questionnaires assessing ASD and PTSD symptoms, psychological distress, personality and trait anxiety, coping, and QOL at inclusion and 3, 6, 9, 12 months after inclusion. Socio-demographic and clinical information will be abstracted from the patientsí» medical records. The medical ethical committee Brabant (METC Brabant) approved the study.

Trial website:
http://www.elisabethtopzorg.nl/index.php/trauma/professionals/projecten/87-emdr-bij-patienten-met-een-acute-stressstoornis
- Main changes (audit trail)7-mei-2017: added trial website at short resume - MT
- RECORD15-mrt-2017 - 7-mei-2017


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