Cortisol Augmentation of Prolonged Exposure Therapy

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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Cortisol Augmentation of Prolonged Exposure Therapy

Conditions
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PTSD

Intervention / Treatment
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* Behavioral: Prolonged Exposure therapy
* Drug: Hydrocortisone
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veterans who experienced a criterion A trauma while deployed, and a current diagnosis of PTSD with a minimum of 6 months Capable of understanding, reading and writing English Exclusion Criteria: Incapable and/or unwilling to provide written informed consent prior to participation Unwilling and/or unable to discontinue current psychotherapy Regular use of psychotropic medication including antidepressants, benzodiazepines, lithium, mood stabilizers, over-the-counter supplements (melatonin, kava-kava, ephedra) Regular use of oral or inhaled steroids Significant illness (e.g., type I or II diabetes requiring the use of insulin, HIV, AIDS, seizure disorder, anemia, Lyme disease, etc.) The veteran, the veteran's physician, or the study physician think that the veteran's clinical state necessitates the prompt initiation of pharmacotherapy or other treatment that would preclude involvement in the study Morbid obesity (VMI > 40) Clinically significant laboratory abnormalities as determine during medical clearance procedures For women, a positive pregnancy test Heavy smoking (more than 2 packs a day) Substance and/or alcohol abuse and/or dependence within the previous 6 months Response of 3 or 4 on the suicidality items of the HDRS or an assessed serious suicide risk Current psychosocial problems that might interfere with treatment compliance A lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, obsessive compulsive disorder or PTSD due to a trauma not sustained in the combat theater

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: 1<br>Prolonged Exposure therapy with Hydrocortisone | Behavioral: Prolonged Exposure therapy<br>* 10 weekly sessions<br>Drug: Hydrocortisone<br>* 30mg 45 minutes prior to each PE session including imaginal exposure (8 total)<br>|
| Placebo Comparator: 2<br>Prolonged Exposure therapy with placebo | Behavioral: Prolonged Exposure therapy<br>* 10 weekly sessions<br>Drug: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS) |  | Baseline (Week 0), endpoint (week 11) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive performance (learning and retention in an episodic memory task, attention and working memory) |  | Baseline (Week 0), endpoint (week 11) | 
| Other measures of clinical outcome, psychological state and functioning |  | Approximately 1 week prior to starting therapy (Week 0) and approximately 1 week after completing 10 weeks of therapy (week 11) | 
| Biological measures associated with PTSD severity |  | Approximately 1 week prior to starting therapy (Week 0) and approximately 1 week after completing 10 weeks of therapy (week 11) |