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

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.

Study Overview

• Status: Unknown
• Conditions: PTSD
• Intervention / Treatment: Behavioral: Prolonged Exposure therapy; Drug: Hydrocortisone

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Prolonged Exposure therapy with Hydrocortisone	Behavioral: Prolonged Exposure therapy; 10 weekly sessions; Drug: Hydrocortisone; 30mg 20 minutes prior to each PE session including imaginal exposure (8 total)
PLACEBO_COMPARATOR: Prolonged Exposure therapy with placebo	Behavioral: Prolonged Exposure therapy; 10 weekly sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)	week 0
PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)	week 10
PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)	week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
Cognitive performance (learning and retention in an episodic memory task, attention and working memory)	week 0
Cognitive performance (learning and retention in an episodic memory task, attention and working memory)	week 10
Cognitive performance (learning and retention in an episodic memory task, attention and working memory)	week 16
Other measures of clinical outcome, psychological state and functioning	week 0
Other measures of clinical outcome, psychological state and functioning	week 10
Other measures of clinical outcome, psychological state and functioning	week 16
Biological measures associated with PTSD severity	week 0
Biological measures associated with PTSD severity	week 10
Biological measures associated with PTSD severity	week 16

Collaborators and Investigators

• Sponsor: Bronx VA Medical Center
• Collaborators: Lightfighter Trust

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ANTICIPATED): November 1, 2013

Study Registration Dates

• First Submitted: March 11, 2010
• First Submitted That Met QC Criteria: March 19, 2010
• First Posted (ESTIMATE): March 22, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 5, 2013
• Last Update Submitted That Met QC Criteria: February 4, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Anti-Inflammatory Agents; Hydrocortisone
• Other Study ID Numbers: LFT2009-02-1