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Cortisol Augmentation of Prolonged Exposure Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00751855
Recruitment Status : Completed
First Posted : September 12, 2008
Last Update Posted : July 27, 2012
Information provided by:
Bronx VA Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
PTSD Behavioral: Prolonged Exposure therapy Drug: Hydrocortisone Drug: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cortisol Augmentation of Prolonged Exposure Therapy
Study Start Date : July 2008
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

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
Behavioral: Prolonged Exposure therapy
10 weekly sessions

Drug: placebo

Primary Outcome Measures :
  1. Change in PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS) [ Time Frame: Baseline (Week 0), endpoint (week 11) ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00751855

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United States, New York
James J. Peters Veterans Affairs Medical Center
Bronx, New York, United States, 10468
Sponsors and Collaborators
VISN 3 Mental Illness Research, Education and Clinical Center
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Responsible Party: Rachel Yehuda, James J. Peters VA Medical Center Identifier: NCT00751855    
Other Study ID Numbers: YEH-08-044
First Posted: September 12, 2008    Key Record Dates
Last Update Posted: July 27, 2012
Last Verified: October 2010
Additional relevant MeSH terms:
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Anti-Inflammatory Agents