A Correlation Between Hair Cortisol Levels and the Development of Post Traumatic Stress Disorder (PTSD)

NCT ID: NCT02033395

Last Updated: 2014-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Post Traumatic Stress Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants exposed to tramautic event

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

Central Contacts

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Eldor Rogev, MD

Role: CONTACT

972-3-530-3300

Facility Contacts

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Eldor Rogev, MD

Role: primary

972-3-5303300

Other Identifiers

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SHEBA-13-0910-JZ-CTIL

Identifier Type: -

Identifier Source: org_study_id

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