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

NCT02033395 | Unknown

• 1 other identifier: SHEBA-13-0910-JZ-CTIL
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• PTSD diagnosis and symptom severity as measured by Clinician Administered PTSD Scale (CAPS).

  13 months

Study Arms (1)

Participants exposed to tramautic event

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women, age 18-70, who were examined in the ER following a traumatic event.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Eldor Rogev, MD

CONTACT

972-3-530-3300; eldor.rogev@sheba.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: January 10, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Last Updated: January 10, 2014

Record last verified: 2014-01

Locations

IL (1)