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

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ClinicalTrials.gov Identifier: NCT02033395
Recruitment Status : Unknown
Verified January 2014 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 10, 2014
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

Tracking Information
First Submitted Date January 9, 2014
First Posted Date January 10, 2014
Last Update Posted Date January 10, 2014
Study Start Date January 2014
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 9, 2014)
PTSD diagnosis and symptom severity as measured by Clinician Administered PTSD Scale (CAPS). [ Time Frame: 13 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Correlation Between Hair Cortisol Levels and the Development of Post Traumatic Stress Disorder (PTSD)
Official Title A Correlation Between Hair Cortisol Levels and the Development of Post Traumatic Stress Disorder (PTSD)
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

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Men and women, age 18-70, who were examined in the ER following a traumatic event.
Condition Post Traumatic Stress Disorder
Intervention Not Provided
Study Groups/Cohorts Participants exposed to tramautic event
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 9, 2014)
60
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT02033395
Other Study ID Numbers SHEBA-13-0910-JZ-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sheba Medical Center
Study Sponsor Sheba Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Sheba Medical Center
Verification Date January 2014