Cortisol 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: Completed
• Conditions: PTSD
• Intervention / Treatment: Drug: placebo; Behavioral: Prolonged Exposure therapy; Drug: Hydrocortisone

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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: 1; Prolonged Exposure therapy with Hydrocortisone	Behavioral: Prolonged Exposure therapy; 10 weekly sessions; Drug: Hydrocortisone; 30mg 45 minutes prior to each PE session including imaginal exposure (8 total)
Placebo Comparator: 2; Prolonged Exposure therapy with placebo	Drug: placebo; placebo; Behavioral: Prolonged Exposure therapy; 10 weekly sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)	Baseline (Week 0), endpoint (week 11)

Secondary Outcome Measures

Outcome Measure	Time Frame
Cognitive performance (learning and retention in an episodic memory task, attention and working memory)	Baseline (Week 0), endpoint (week 11)
Other measures of clinical outcome, psychological state and functioning	Approximately 1 week prior to starting therapy (Week 0) and approximately 1 week after completing 10 weeks of therapy (week 11)
Biological measures associated with PTSD severity	Approximately 1 week prior to starting therapy (Week 0) and approximately 1 week after completing 10 weeks of therapy (week 11)

Collaborators and Investigators

• Sponsor: VISN 3 Mental Illness Research, Education and Clinical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: September 11, 2008
• First Submitted That Met QC Criteria: September 11, 2008
• First Posted (Estimate): September 12, 2008

Study Record Updates

• Last Update Posted (Estimate): July 27, 2012
• Last Update Submitted That Met QC Criteria: July 26, 2012
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Inflammatory Agents; Hydrocortisone
• Other Study ID Numbers: YEH-08-044