A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure

NCT ID: NCT01525680

Last Updated: 2013-11-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30

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

Post Traumatic Stress Disorder

Keywords

PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Prolonged Exposure therapy with Hydrocortisone

Group Type: ACTIVE_COMPARATOR

Hydrocortisone augmented Prolonged Exposure Therapy

Intervention Type: OTHER

11 sessions of PE. 20 minutes prior to final eight sessions, 30 mg hydrocortisone is administered.

Prolonged Exposure therapy with placebo

Group Type: PLACEBO_COMPARATOR

Prolonged exposure therapy with placebo administration

Intervention Type: OTHER

11 sessions of PE. 20 minutes prior to final eight sessions, placebo is administered.

Interventions

Hydrocortisone augmented Prolonged Exposure Therapy

11 sessions of PE. 20 minutes prior to final eight sessions, 30 mg hydrocortisone is administered.

Intervention Type: OTHER

Prolonged exposure therapy with placebo administration

11 sessions of PE. 20 minutes prior to final eight sessions, placebo is administered.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 18 to 89
• Capable of understanding, reading, and writing in English
• OIF/OEF veteran with criterion-A trauma while deployed
• Minimum PTSD severity of 60 (CAPS)
• Unmedicated or on a stable psychotropic regimen (i.e., 1 or more months on the same regimen)

Exclusion Criteria

• Lifetime history of psychotropic 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 11 weeks of study treatment and the 3 month 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Bronx VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Rachel Yehuda

MHPCCD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel Yehuda, PhD

Role: PRINCIPAL_INVESTIGATOR

James J Peters VAMC/Mount Sinai School of Medicine

Locations

James J. Peters Veterans Affairs Medical Center

The Bronx, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rachel Yehuda, PhD

Role: CONTACT

Phone: 718-741-4000

Email: rachel.yehuda@va.gov

Facility Contacts

Rachel Yehuda, PhD

Role: primary

Other Identifiers

YEH-09-087

Identifier Type: -

Identifier Source: org_study_id