Skip to main content
OpenTrials
Completed

NCT Number: NCT00751855

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

James J. Peters Veterans Affairs Medical Center

The Bronx, New York, 10468, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prolonged Exposure Therapy

Behavioral

10 weekly sessions

Hydrocortisone

Drug

30mg 45 minutes prior to each PE session including imaginal exposure (8 total)

Placebo

Drug

placebo

Primary outcomes

  1. Change in PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)

    Time frame: Baseline (Week 0), endpoint (week 11)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

VISN 3 Mental Illness Research, Education and Clinical Center

Fed

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 12, 2008
Registry last updated
Jul 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.