A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 4/2/2016 |
| Start Date: | April 2011 |
| Contact: | Rachel Yehuda, PhD |
| Email: | rachel.yehuda@va.gov |
| Phone: | 718-741-4000 |
Improving PTSD Outcomes in OIF/OEF Returnees: A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure Therapy"
This study seeks to examine the efficacy of hydrocortisone administration in the
augmentation of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically
tested treatment shown to be effective in the the treatment of posttraumatic stress disorder
(PTSD). The augmentation builds on both the translation of neuroscience findings
demonstrating the effects of glucocorticoids (GCs) on learning, and on empirical clinical
findings from other investigators demonstrating beneficial effects of GCs in reducing
traumatic memories in trauma-exposed persons.
augmentation of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically
tested treatment shown to be effective in the the treatment of posttraumatic stress disorder
(PTSD). The augmentation builds on both the translation of neuroscience findings
demonstrating the effects of glucocorticoids (GCs) on learning, and on empirical clinical
findings from other investigators demonstrating beneficial effects of GCs in reducing
traumatic memories in trauma-exposed persons.
Inclusion Criteria:
- Age 18 to 89
- Capable of understanding, reading, and writing in English
- OIF/OEF veteran with criterion-A trauma while deployed
- Minimum PTSD severity of 60 (CAPS)
- Unmedicated or on a stable psychotropic regimen (i.e., 1 or more months on the same
regimen)
Exclusion Criteria:
- Lifetime history of psychotropic disorder, bipolar disorder, or obsessive compulsive
disorder
- Moderate or severe traumatic brain injury (TBI)
- A medical or mental health problem other than PTSD that requires immediate clinical
attention
- Substance abuse or dependence within the last 3 months
- Suicidal risk (as determined by response of 5 or 6 on the suicidality items of the
Montgomery-Asberg Depression Rating Scale (MADRS)) and/or assessed suicide risk on
the basis of clinical judgment
- Persons on a psychotropic medication regimen that has not been consistent for one
month
- Presence of diabetes mellitus or any current unstable medical illness or condition
that represents a contraindication to taking glucocorticoids (this will be determined
by history and/or abnormal laboratory findings at medical clearance)
- Unwillingness to discontinue other specialized psychotherapy for PTSD during the 11
weeks of study treatment and the 3 month follow-up (Self-help (non-trauma focused)
groups or supportive counseling can be continued but not initiated)
- Pregnant women or those planning to become pregnant within the study period will not
be enrolled. Female participants must agree to use an effective method of birth
control (i.e., oral contraceptive, Norplant, diaphragm, condom, or spermicide,
abstinence) during the course of the study to ensure they do not become pregnant
during the course of the study
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