Cortisol Augmentation of Prolonged Exposure Therapy

This study has been completed.
Sponsor:
Information provided by:
Bronx VA Medical Center
ClinicalTrials.gov Identifier:
NCT00751855
First received: September 11, 2008
Last updated: July 26, 2012
Last verified: October 2010
  Purpose

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 Intervention
PTSD
Behavioral: Prolonged Exposure therapy
Drug: Hydrocortisone
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cortisol Augmentation of Prolonged Exposure Therapy

Resource links provided by NLM:


Further study details as provided by Bronx VA Medical Center:

Primary Outcome Measures:
  • Change in PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS) [ Time Frame: Baseline (Week 0), endpoint (week 11) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive performance (learning and retention in an episodic memory task, attention and working memory) [ Time Frame: Baseline (Week 0), endpoint (week 11) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: July 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751855

Locations
United States, New York
James J. Peters Veterans Affairs Medical Center
Bronx, New York, United States, 10468
Sponsors and Collaborators
VISN3 Mental Illness Research, Education and Clinical Center
  More Information

No publications provided

Responsible Party: Rachel Yehuda, James J. Peters VA Medical Center
ClinicalTrials.gov Identifier: NCT00751855     History of Changes
Other Study ID Numbers: YEH-08-044
Study First Received: September 11, 2008
Last Updated: July 26, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on August 27, 2014