Cortisol Augmentation of Prolonged Exposure Therapy

Condition(s) targeted: PTSD

Intervention: Prolonged Exposure therapy (Behavioral); Hydrocortisone (Drug); placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: VISN3 Mental Illness Research, Education and Clinical Center

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: Cortisol Augmentation of Prolonged Exposure Therapy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)

Secondary outcome:

Cognitive performance (learning and retention in an episodic memory task, attention and working memory)

Other measures of clinical outcome, psychological state and functioning

Biological measures associated with PTSD severity

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

James J. Peters Veterans Affairs Medical Center, Bronx, New York 10468, United States

Starting date: July 2008
Last updated: July 26, 2012