A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure

NCT01525680 | Unknown

• 1 other identifier: YEH-09-087
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Clinician Administered PTSD Scale (CAPS)

  Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.

  week 0

• Clinician Administered PTSD Scale (CAPS)

  Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.

  week 12

• Clinician Administered PTSD Scale (CAPS)

  Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.

  week 23

Secondary Outcomes (9)

• Biological measures associated with PTSD

  week 0

• Biological measures associated with PTSD

  week 12

• Biological measures associated with PTSD

  week 23

• MATRICS Consensus Cognitive Battery (MCCB)

  week 0

• MATRICS Consensus Cognitive Battery (MCCB)

  week 12

Study Arms (2)

Prolonged Exposure therapy with Hydrocortisone

ACTIVE COMPARATOR

Other: Hydrocortisone augmented Prolonged Exposure Therapy

Prolonged Exposure therapy with placebo

PLACEBO COMPARATOR

Other: Prolonged exposure therapy with placebo administration

Interventions

Hydrocortisone augmented Prolonged Exposure Therapy OTHER

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

Prolonged Exposure therapy with Hydrocortisone

Prolonged exposure therapy with placebo administration OTHER

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

Prolonged Exposure therapy with placebo

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bronx VA Medical Center: lead
• United States Department of Defense: collaborator

Study Sites (1)

James J. Peters Veterans Affairs Medical Center

The Bronx, New York, 10468, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Rachel Yehuda, PhD

  James J Peters VAMC/Mount Sinai School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Yehuda, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MHPCCD

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: February 3, 2012
• Study Start: April 1, 2011
• Primary Completion: September 1, 2015
• Last Updated: November 28, 2013

Record last verified: 2013-11

Locations

US (1)