Recruiting

Cortisol with Treatment

Sponsor:

Bronx VA Medical Center

Code:

NCT01090518

Conditions

PTSD

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Prolonged Exposure therapy

Hydrocortisone

Prolonged Exposure therapy

Study Details

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.

Conditions

PTSD

Study ID

NCT01090518

Start date

Feb, 2010

Status verified date

Feb, 2013

Primary completion date

Nov, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • A primary diagnosis of chronic PTSD according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria, resulting from a deployment-related traumatic event, and a minimum PTSD severity of 50 (CAPS).
  • The veteran must either be unmedicated or on a stable psychotropic regimen (i.e., 1 or more months on the same regimen).

Exclusion Criteria:

  • Lifetime history of psychotic disorder, bipolar disorder, or obsessive compulsive disorder.
  • Moderate or severe traumatic brain injury (TBI).
  • A medical or mental health problem other than PTSD that requires immediate clinical attention.
  • Substance abuse or dependence within the last 3 months.
  • Suicidal risk (as determined by response of 5 or 6 on the suicidality items of the Montgomery Asberg Depression Rating Scale (MADRS)) and/or assessed suicide risk on the basis of clinical judgment.
  • Persons on a psychotropic medication regimen that has not been consistent for one month.
  • Presence of diabetes mellitus or any current unstable medical illness or condition that represents a contraindication to taking glucocorticoids (this will be determined by history and/or abnormal laboratory findings at medical clearance).
  • Unwillingness to discontinue other specialized psychotherapy for PTSD during the 10 weeks of study treatment and the 6 week follow-up. (Self-help (non-trauma focused) groups or supportive counseling can be continued but not initiated.)
  • Pregnant women or those planning to become pregnant within the study period will not be enrolled. Female participants must agree to use an effective method of birth control (i.e., oral contraceptive, Norplant, diaphragm, condom, or spermicide, abstinence) during the course of the study to ensure they do not become pregnant during the course of the study.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Prolonged Exposure therapy with Hydrocortisone

placebo comparator: Prolonged Exposure therapy with placebo

Interventions

Prolonged Exposure therapy

10 weekly sessions

Hydrocortisone

30mg 20 minutes prior to each PE session including imaginal exposure (8 total)

Prolonged Exposure therapy

10 weekly sessions

Primary outcome measure

  • PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS) [ Time Frame: week 0 ]
  • PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS) [ Time Frame: week 10 ]
  • PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS) [ Time Frame: week 16 ]

Central Contacts and Locations

Central contacts

Rachel Yehuda, PhD

718-741-4000rachel.yehuda@va.gov

Locations

James J. Peters Veterans Affairs Medical Center

Recruiting

Bronx, New York, United States, 10468

Principal Investigator:

Rachel Yehuda, PhD

More Information

Sponsor

Bronx VA Medical Center

Last update posted

Feb 5, 2013

Last verified

Feb, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bronx VA Medical Center on 2013-02-05.