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Cortisol Augmentation of Prolonged Exposure Therapy

NCT ID: NCT00751855

Last Updated: 2012-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Prolonged Exposure therapy with Hydrocortisone

Group Type ACTIVE_COMPARATOR

Prolonged Exposure therapy

Intervention Type BEHAVIORAL

10 weekly sessions

Hydrocortisone

Intervention Type DRUG

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

2

Prolonged Exposure therapy with placebo

Group Type PLACEBO_COMPARATOR

Prolonged Exposure therapy

Intervention Type BEHAVIORAL

10 weekly sessions

placebo

Intervention Type DRUG

placebo

Interventions

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Prolonged Exposure therapy

10 weekly sessions

Intervention Type BEHAVIORAL

Hydrocortisone

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

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VISN 3 Mental Illness Research, Education and Clinical Center

FED

Sponsor Role lead

Responsible Party

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James J. Peters VA Medical Center

Locations

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James J. Peters Veterans Affairs Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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YEH-08-044

Identifier Type: -

Identifier Source: org_study_id