Cortisol Augmentation of a Psychological Treatment in Warfighters With Post Traumatic Stress Disorder (PTSD)

Condition(s) targeted: PTSD

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

Phase: N/A

Status: Recruiting

Sponsored by: Bronx VA Medical Center

Overall contact:
Rachel Yehuda, PhD, Phone: 718-741-4000, Ext: 6964, Email: rachel.yehuda@va.gov

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 a Psychological Treatment in Warfighters With Post Traumatic Stress Disorder (PTSD)

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:

PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)

PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)

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)

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

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

Other measures of clinical outcome, psychological state and functioning

Other measures of clinical outcome, psychological state and functioning

Other measures of clinical outcome, psychological state and functioning

Biological measures associated with PTSD severity

Biological measures associated with PTSD severity

Biological measures associated with PTSD severity

Minimum age: 18 Years. Maximum age: 89 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- A primary diagnosis of chronic PTSD according to Diagnostic and Statistical Manual of

Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria, resulting from a deployment-related traumatic event, and a minimum PTSD severity of 50 (CAPS).

- The veteran must either be unmedicated or on a stable psychotropic regimen (i. e., 1

or more months on the same regimen). Exclusion Criteria:

- Lifetime history of psychotic 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 10

weeks of study treatment and the 6 week 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.

Rachel Yehuda, PhD, Phone: 718-741-4000, Ext: 6964, Email: rachel.yehuda@va.gov

James J. Peters Veterans Affairs Medical Center, Bronx, New York 10468, United States; Recruiting
Rachel Yehuda, PhD, Principal Investigator

Starting date: February 2010
Last updated: February 4, 2013