Cortisol Augmentation of Prolonged Exposure Therapy

VISN 3 Mental Illness Research, Education and Clinical Center

Status

Completed

Conditions

PTSD

Treatments

Drug: Hydrocortisone

Drug: placebo

Behavioral: Prolonged Exposure therapy

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00751855

YEH-08-044

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

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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