A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure

Bronx VA Medical Center

Status: Unknown

Conditions: Post Traumatic Stress Disorder

Treatments: Other: Hydrocortisone augmented Prolonged Exposure Therapy; Other: Prolonged exposure therapy with placebo administration

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01525680

YEH-09-087

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Prolonged Exposure therapy with Hydrocortisone

Active Comparator group

Treatment:

Other: Hydrocortisone augmented Prolonged Exposure Therapy

Prolonged Exposure therapy with placebo

Placebo Comparator group

Treatment:

Other: Prolonged exposure therapy with placebo administration