A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure

Improving PTSD Outcomes in OIF/OEF Returnees: A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure Therapy"

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: Post Traumatic Stress Disorder
• Intervention / Treatment: Other: Hydrocortisone augmented Prolonged Exposure Therapy; Other: Prolonged exposure therapy with placebo administration

• Study Type: Interventional
• Enrollment (Anticipated): 60
• 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
      • Contact: Rachel Yehuda, PhD; Email: rachel.yehuda@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Prolonged Exposure therapy with Hydrocortisone	Other: Hydrocortisone augmented Prolonged Exposure Therapy; 11 sessions of PE. 20 minutes prior to final eight sessions, 30 mg hydrocortisone is administered.
Placebo Comparator: Prolonged Exposure therapy with placebo	Other: Prolonged exposure therapy with placebo administration; 11 sessions of PE. 20 minutes prior to final eight sessions, placebo is administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Administered PTSD Scale (CAPS)	Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.	week 0
Clinician Administered PTSD Scale (CAPS)	Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.	week 12
Clinician Administered PTSD Scale (CAPS)	Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.	week 23

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological measures associated with PTSD	Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor.	week 0
Biological measures associated with PTSD	Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor.	week 12
Biological measures associated with PTSD	Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor.	week 23
MATRICS Consensus Cognitive Battery (MCCB)	Measure of cognitive ability in the following domains: processing speed, attention, working memory (verbal and non-verbal), verbal learning, visual learning, reasoning and problem solving, and social cognition.	week 0
MATRICS Consensus Cognitive Battery (MCCB)	Measure of cognitive ability in the following domains: processing speed, attention, working memory (verbal and non-verbal), verbal learning, visual learning, reasoning and problem solving, and social cognition.	week 12
MATRICS Consensus Cognitive Battery (MCCB)	Measure of cognitive ability in the following domains: processing speed, attention, working memory (verbal and non-verbal), verbal learning, visual learning, reasoning and problem solving, and social cognition.	week 23
Other measures of clinical, psychological, and functional outcome	Measures of symptom severity, trauma-related cognitions, and resiliency.	week 0
Other measures of clinical, psychological, and functional outcome	Measures of symptom severity, trauma-related cognitions, and resiliency.	week 12
Other measures of clinical, psychological, and functional outcome	Measures of symptom severity, trauma-related cognitions, and resiliency.	week 23

Collaborators and Investigators

• Sponsor: Bronx VA Medical Center
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Rachel Yehuda, PhD, James J Peters VAMC/Mount Sinai School of Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: February 1, 2012
• First Submitted That Met QC Criteria: February 2, 2012
• First Posted (Estimate): February 3, 2012

Study Record Updates

• Last Update Posted (Estimate): November 28, 2013
• Last Update Submitted That Met QC Criteria: November 27, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: PTSD
• 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: YEH-09-087