Hydrocortisone for Prevention of Post-Traumatic Stress Disorder
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | May 2015 |
| End Date: | May 2017 |
| Contact: | James Gardner, MD |
| Email: | GardneJa@einstein.edu |
| Phone: | 2154566679 |
Post-Traumatic Stress Disorder (PTSD) is an acquired psychiatric condition that occurs after
exposure to a dangerous or life-threatening event. It is characterized by persistent fear-
and stress-related symptoms, such as nightmares, flashbacks, depression, anxiety and guilt.
These symptoms can interfere significantly with patients' lives and in some cases can be
debilitating. One of the most frequent causes of PTSD is being a victim of a violent,
interpersonal assault.
PTSD is felt to be primarily a disorder of memory formation - stressful memories are encoded
too strongly in a patient's long term memory, remaining too accessible and "present" to the
patient long after the actual threat has passed. In recent years evidence has emerged that
it may be possible to prevent PTSD by moderating the process of memory consolidation that
occurs in the hours and days after a traumatic event.
Early research has suggested that enhancing the body's natural cortisol response to a
stressful event may be a safe and effective way of moderating the process of memory
consolidation and promoting adaptive, non-pathological memory encoding. In particular, the
administration of hydrocortisone, a safe and widely used drug that mimics the body's own
cortisol hormone, appears to reduce the risk of developing PTSD in patients who have
sustained a traumatic event. However, this research is still in relatively early stages, and
requires larger trials to confirm its efficacy. In addition, the research thus far has not
adequately targeted assault victims, whom we feel are some of the patients most likely to
benefit from such an approach.
We propose a prospective, placebo-controlled, double-blinded trial of administering
single-dose oral hydrocortisone or placebo to 100 assault victims seen in the Einstein
Medical Center Philadelphia Emergency Department to determine if this approach has efficacy
in preventing PTSD. This study is designed as a pilot study, with the hopes that the data
gathered in it can be used to design a larger and more robust trial in the future.
exposure to a dangerous or life-threatening event. It is characterized by persistent fear-
and stress-related symptoms, such as nightmares, flashbacks, depression, anxiety and guilt.
These symptoms can interfere significantly with patients' lives and in some cases can be
debilitating. One of the most frequent causes of PTSD is being a victim of a violent,
interpersonal assault.
PTSD is felt to be primarily a disorder of memory formation - stressful memories are encoded
too strongly in a patient's long term memory, remaining too accessible and "present" to the
patient long after the actual threat has passed. In recent years evidence has emerged that
it may be possible to prevent PTSD by moderating the process of memory consolidation that
occurs in the hours and days after a traumatic event.
Early research has suggested that enhancing the body's natural cortisol response to a
stressful event may be a safe and effective way of moderating the process of memory
consolidation and promoting adaptive, non-pathological memory encoding. In particular, the
administration of hydrocortisone, a safe and widely used drug that mimics the body's own
cortisol hormone, appears to reduce the risk of developing PTSD in patients who have
sustained a traumatic event. However, this research is still in relatively early stages, and
requires larger trials to confirm its efficacy. In addition, the research thus far has not
adequately targeted assault victims, whom we feel are some of the patients most likely to
benefit from such an approach.
We propose a prospective, placebo-controlled, double-blinded trial of administering
single-dose oral hydrocortisone or placebo to 100 assault victims seen in the Einstein
Medical Center Philadelphia Emergency Department to determine if this approach has efficacy
in preventing PTSD. This study is designed as a pilot study, with the hopes that the data
gathered in it can be used to design a larger and more robust trial in the future.
Adult subjects will be screened in the Emergency Department (ED) by research associates. If
they meet inclusion/exclusion criteria they will be offered enrollment. Subjects who choose
to enroll will be randomized to receive either hydrocortisone 120mg PO, or placebo PO, one
time in the Emergency Department. They will be given a packet of general information on
traumatic stress and contact information for psychiatric assistance if they require it, but
no further PTSD treatment will be given. Any further medical treatment will be at the
discretion of the treating team.
At 6 weeks after enrollment subjects will be contacted by phone, and a brief structured
interview, based on the PCL-S (a well-validated screening instrument for PTSD), will be
administered by phone. Participants who screen positive will be informed that they may be
suffering from PTSD, and will be offered the opportunity to seek care with the Einstein
Psychiatry Department's PTSD program.
At 6 months after enrollment subjects will again be contacted and administered the PCL-C, as
well as questions regarding other psychiatric comorbidities, substance use, and involvement
in any further episodes of violence. In addition, review of subject medical records over the
year since injury will be undertaken to determine if there is any difference in subsequent
health-care utilization between those who received hydrocortisone vs placebo and between
those who screen positive for PTSD vs those who don't.
they meet inclusion/exclusion criteria they will be offered enrollment. Subjects who choose
to enroll will be randomized to receive either hydrocortisone 120mg PO, or placebo PO, one
time in the Emergency Department. They will be given a packet of general information on
traumatic stress and contact information for psychiatric assistance if they require it, but
no further PTSD treatment will be given. Any further medical treatment will be at the
discretion of the treating team.
At 6 weeks after enrollment subjects will be contacted by phone, and a brief structured
interview, based on the PCL-S (a well-validated screening instrument for PTSD), will be
administered by phone. Participants who screen positive will be informed that they may be
suffering from PTSD, and will be offered the opportunity to seek care with the Einstein
Psychiatry Department's PTSD program.
At 6 months after enrollment subjects will again be contacted and administered the PCL-C, as
well as questions regarding other psychiatric comorbidities, substance use, and involvement
in any further episodes of violence. In addition, review of subject medical records over the
year since injury will be undertaken to determine if there is any difference in subsequent
health-care utilization between those who received hydrocortisone vs placebo and between
those who screen positive for PTSD vs those who don't.
Inclusion Criteria:
1. Older than age 18
2. Presenting to ER for treatment of injuries sustained in a violent physical assault
3. Assault met DSM-IV "A" criterion (in patient's view, the assault involved or
threatened death or serious injury)
4. Patient will be discharged home from Emergency Room
Exclusion Criteria:
1. Intoxicated due to drugs, alcohol or medication at the time they are approached.
2. Under arrest or in police custody at the time they are approached.
3. No memory of the assault
4. Cognitive impairment or psychosis identified by the treating physician or on chart
review.
5. Patients whose presenting injury is a result of domestic (i.e. injured by a primary
caregiver or significant other) or sexual violence
6. Under age 18
7. Not medically stable enough to participate
8. Non-English speakers
9. Pregnant or nursing women
10. Already on steroid treatment
11. Immunosuppressed (taking immunosuppressant medication, cancer undergoing active
chemotherapy, AIDS, HIV not on HAART therapy)
12. Have an active infection identified by the treating physician or on chart review
13. Allergy or adverse reaction to hydrocortisone or other corticosteroids
14. Diabetic
15. On warfarin therapy
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