Cortisol Augmentation of a Psychological Treatment in Warfighters With Post Traumatic Stress Disorder (PTSD)

NCT01090518 | Unknown

• 1 other identifier: LFT2009-02-1
• Study Type: interventional
• Target: 50
• 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

PTSD

Outcome Measures

Primary Outcomes (3)

• PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)

  week 0

• PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)

  week 10

• PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)

  week 16

Secondary Outcomes (9)

• Cognitive performance (learning and retention in an episodic memory task, attention and working memory)

  week 0

• Cognitive performance (learning and retention in an episodic memory task, attention and working memory)

  week 10

• Cognitive performance (learning and retention in an episodic memory task, attention and working memory)

  week 16

• Other measures of clinical outcome, psychological state and functioning

  week 0

• Other measures of clinical outcome, psychological state and functioning

  week 10

Study Arms (2)

Prolonged Exposure therapy with Hydrocortisone

ACTIVE COMPARATOR

Behavioral: Prolonged Exposure therapy; Drug: Hydrocortisone

Prolonged Exposure therapy with placebo

PLACEBO COMPARATOR

Behavioral: Prolonged Exposure therapy

Interventions

Prolonged Exposure therapy BEHAVIORAL

10 weekly sessions

Prolonged Exposure therapy with Hydrocortisone

Hydrocortisone DRUG

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

Prolonged Exposure therapy with Hydrocortisone

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bronx VA Medical Center: lead
• Lightfighter Trust: 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

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

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: PhD, Professor of Neuroscience and Psychiatry

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 22, 2010
• Study Start: February 1, 2010
• Primary Completion: November 1, 2013
• Last Updated: February 5, 2013

Record last verified: 2013-02

Locations

US (1)