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Cortisol Augmentation of Prolonged Exposure Therapy

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ClinicalTrials.gov Identifier: NCT00751855
Recruitment Status : Completed
First Posted : September 12, 2008
Last Update Posted : July 27, 2012
Sponsor:
Information provided by:
Bronx VA Medical Center

Tracking Information
First Submitted Date  ICMJE September 11, 2008
First Posted Date  ICMJE September 12, 2008
Last Update Posted Date July 27, 2012
Study Start Date  ICMJE July 2008
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2011)
Change in PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS) [ Time Frame: Baseline (Week 0), endpoint (week 11) ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2008)
Change in PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS) [ Time Frame: pre-treatment evaluation, post-treatment evaluation ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2011)
  • Cognitive performance (learning and retention in an episodic memory task, attention and working memory) [ Time Frame: Baseline (Week 0), endpoint (week 11) ]
  • 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) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2008)
  • Cognitive performance (learning and retention in an episodic memory task, attention and working memory) [ Time Frame: pre-treatment evaluation and post-treatment evaluation ]
  • Other measures of clinical outcome, psychological state and functioning [ Time Frame: pre-treatment evaluation and post-treatment evaluation ]
  • Biological measures associated with PTSD severity [ Time Frame: pre-treatment evaluation and post-treatment evaluation ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cortisol Augmentation of Prolonged Exposure Therapy
Official Title  ICMJE Cortisol Augmentation of Prolonged Exposure Therapy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE PTSD
Intervention  ICMJE
  • Behavioral: Prolonged Exposure therapy
    10 weekly sessions
  • Drug: Hydrocortisone
    30mg 45 minutes prior to each PE session including imaginal exposure (8 total)
  • Drug: placebo
    placebo
Study Arms  ICMJE
  • Active Comparator: 1
    Prolonged Exposure therapy with Hydrocortisone
    Interventions:
    • Behavioral: Prolonged Exposure therapy
    • Drug: Hydrocortisone
  • Placebo Comparator: 2
    Prolonged Exposure therapy with placebo
    Interventions:
    • Behavioral: Prolonged Exposure therapy
    • Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2011)
11
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2008)
16
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00751855
Other Study ID Numbers  ICMJE YEH-08-044
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rachel Yehuda, James J. Peters VA Medical Center
Study Sponsor  ICMJE VISN 3 Mental Illness Research, Education and Clinical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bronx VA Medical Center
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP