- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02033395
A Correlation Between Hair Cortisol Levels and the Development of Post Traumatic Stress Disorder (PTSD)
This observational study follows subjects who have been exposed to a traumatic event and are at risk of developing PTSD symptoms. Participants are recruited within six hours of a traumatic event, and, starting from the recruitment session, are then examined on six set points of time within a period of thirteen months. The examinations include both biological studies of cortisol in hair, blood and saliva, and psychological examinations and questionaires that assess the development and severity of PTSD symptoms.
The novel method of sampling hair cortisol allows investigators to retroactively estimate the mean levels of blood cortisol during the tree months prior to the sampling.
The study aims at further illuminating the correlation between cortisol levels both prior and following a traumatic event, and the development and severity of PTSD symptoms
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Tel Hashomer, Israel, 52621
- Chaim Sheba Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Age 18-70.
- Experienced a traumatic and were at risk (or perceived risk) of serious injury to themselves or others in their surroundings.
- Signed an informed consent form.
Exclusion Criteria:
- Age under 18 or over 70.
- Severe or complex physical injury, such as severe head trauma, massive burns or injuries that require surgery under full anesthesia.
- A personal history of Psychotic state or PTSD.
- Pregnancy
- Weight below 45 Kg or over 120 Kg.
- Hair shorter than 1.5 cm.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Participants exposed to tramautic event
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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PTSD diagnosis and symptom severity as measured by Clinician Administered PTSD Scale (CAPS).
Tidsramme: 13 months
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13 months
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SHEBA-13-0910-JZ-CTIL
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