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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
11 sessions of PE. 20 minutes prior to final eight sessions, 30 mg hydrocortisone is administered.
11 sessions of PE. 20 minutes prior to final eight sessions, placebo is administered.
James J. Peters Veterans Affairs Medical Center
The Bronx, New York, United States
RECRUITINGClinician Administered PTSD Scale (CAPS)
Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.
Time frame: week 0
Clinician Administered PTSD Scale (CAPS)
Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.
Time frame: week 12
Clinician Administered PTSD Scale (CAPS)
Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.
Time frame: week 23
Biological measures associated with PTSD
Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor.
Time frame: week 0
Biological measures associated with PTSD
Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor.
Time frame: week 12
Biological measures associated with PTSD
Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor.
Time frame: week 23
MATRICS Consensus Cognitive Battery (MCCB)
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.
Time frame: week 0
MATRICS Consensus Cognitive Battery (MCCB)
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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.
Time frame: week 12
MATRICS Consensus Cognitive Battery (MCCB)
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.
Time frame: week 23
Other measures of clinical, psychological, and functional outcome
Measures of symptom severity, trauma-related cognitions, and resiliency.
Time frame: week 0
Other measures of clinical, psychological, and functional outcome
Measures of symptom severity, trauma-related cognitions, and resiliency.
Time frame: week 12
Other measures of clinical, psychological, and functional outcome
Measures of symptom severity, trauma-related cognitions, and resiliency.
Time frame: week 23