Post Traumatic Stress Disorder
Conditions
Keywords
PTSD
Brief summary
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.
Interventions
OTHERHydrocortisone augmented Prolonged Exposure Therapy
11 sessions of PE. 20 minutes prior to final eight sessions, 30 mg hydrocortisone is administered.
OTHERProlonged exposure therapy with placebo administration
11 sessions of PE. 20 minutes prior to final eight sessions, placebo is administered.
Sponsors
United States Department of Defense
Bronx VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered PTSD Scale (CAPS) | week 0 | Assessment of the severity of PTSD symptoms and of diagnosis of PTSD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biological measures associated with PTSD | week 0 | Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor. |
| MATRICS Consensus Cognitive Battery (MCCB) | week 0 | Measure of cognitive ability in the following domains: processing speed, attention, working memory (verbal and non-verbal), verbal learning, visual learning, reasoning and problem solving, and social cognition. |
| Other measures of clinical, psychological, and functional outcome | week 0 | Measures of symptom severity, trauma-related cognitions, and resiliency. |
Countries
United States
Contacts
Primary ContactRachel Yehuda, PhD
Outcome results
None listed