A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure

Study Overview
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Brief Summary
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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.

Official Title
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Improving PTSD Outcomes in OIF/OEF Returnees: A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure Therapy

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Other: Hydrocortisone augmented Prolonged Exposure Therapy
* Other: Prolonged exposure therapy with placebo administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prolonged Exposure therapy with Hydrocortisone<br> | Other: Hydrocortisone augmented Prolonged Exposure Therapy<br>* 11 sessions of PE. 20 minutes prior to final eight sessions, 30 mg hydrocortisone is administered.<br>|
| Placebo Comparator: Prolonged Exposure therapy with placebo<br> | Other: Prolonged exposure therapy with placebo administration<br>* 11 sessions of PE. 20 minutes prior to final eight sessions, placebo is administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered PTSD Scale (CAPS) | Assessment of the severity of PTSD symptoms and of diagnosis of PTSD. | week 0 | 
| Clinician Administered PTSD Scale (CAPS) | Assessment of the severity of PTSD symptoms and of diagnosis of PTSD. | week 12 | 
| Clinician Administered PTSD Scale (CAPS) | Assessment of the severity of PTSD symptoms and of diagnosis of PTSD. | week 23 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological measures associated with PTSD | Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor. | week 0 | 
| Biological measures associated with PTSD | Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor. | week 12 | 
| Biological measures associated with PTSD | Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor. | 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. | week 0 | 
| 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. | 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. | week 23 | 
| Other measures of clinical, psychological, and functional outcome | Measures of symptom severity, trauma-related cognitions, and resiliency. | week 0 | 
| Other measures of clinical, psychological, and functional outcome | Measures of symptom severity, trauma-related cognitions, and resiliency. | week 12 | 
| Other measures of clinical, psychological, and functional outcome | Measures of symptom severity, trauma-related cognitions, and resiliency. | week 23 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD