Cortisol Augmentation of Prolonged Exposure Therapy

NCT00751855 | Completed

• 1 other identifier: YEH-08-044
• Study Type: interventional
• Target: 11
• 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 (1)

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

  Baseline (Week 0), endpoint (week 11)

Secondary Outcomes (3)

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

  Baseline (Week 0), endpoint (week 11)

• Other measures of clinical outcome, psychological state and functioning

  Approximately 1 week prior to starting therapy (Week 0) and approximately 1 week after completing 10 weeks of therapy (week 11)

• Biological measures associated with PTSD severity

  Approximately 1 week prior to starting therapy (Week 0) and approximately 1 week after completing 10 weeks of therapy (week 11)

Study Arms (2)

1

ACTIVE COMPARATOR

Prolonged Exposure therapy with Hydrocortisone

Behavioral: Prolonged Exposure therapy; Drug: Hydrocortisone

2

PLACEBO COMPARATOR

Prolonged Exposure therapy with placebo

Behavioral: Prolonged Exposure therapy; Drug: placebo

Interventions

Prolonged Exposure therapy BEHAVIORAL

10 weekly sessions

1; 2

Hydrocortisone DRUG

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

1

placebo DRUG

placebo

2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VISN 3 Mental Illness Research, Education and Clinical Center: lead

Study Sites (1)

James J. Peters Veterans Affairs Medical Center

The Bronx, New York, 10468, United States

Location

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

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

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 12, 2008
• Study Start: July 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: July 27, 2012

Record last verified: 2010-10

Locations

US (1)