Effectiveness of Virtual Reality Exposure Therapy and D-Cycloserine to Treat Iraq War Veterans With Post-Traumatic Stress Disorder

Condition(s) targeted: Stress Disorder, Post Traumatic

Intervention: D-Cycloserine (Drug); Alprazolam (Drug); Virtual Reality Exposure Therapy (Behavioral); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: National Institute of Mental Health (NIMH)

Official(s) and/or principal investigator(s):
Barbara O. Rothbaum, PhD, ABPP, Principal Investigator, Affiliation: Emory University

Overall contact:
Cathrine Arndt Jordan, MS, Phone: 404-712-8300, Email: carndt@emory.edu

This study will determine whether a combination of virtual reality exposure therapy and D-cycloserine will reduce post-traumatic stress disorder symptoms in Iraq war veterans.

Official title: A Cognitive Enhancer May Facilitate Behavioral Exposure Therapy for Veterans With PTSD

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Clinician-Administered PTSD Scale (CAPS)

Secondary outcome:

Psychophysiological measures

PTSD Symptom Scale Self-Report

Clinical Global Impressions Scale

Quality of Life Inventory

State-Trait Anxiety Inventory

Beck Depression Inventory

Detailed description: Post-traumatic stress disorder (PTSD) is a type of anxiety disorder affecting people who have witnessed or experienced a traumatic event. Veterans of war are at an increased risk for developing PTSD because of their experiences with war and combat. Symptoms of PTSD often include flashbacks or nightmares, depression, anxiety or uneasiness, and feeling emotionally numb or distant toward others. Fortunately, PTSD can be treated, usually with some combination of anti-depressants, anti-anxiety medication, and therapy. Virtual reality exposure (VRE) therapy is a new type of treatment that helps people to overcome anxiety about trauma by facing situations with the use of virtual reality. D-cycloserine is a medication that has been found to enhance the effects of psychotherapy in recent studies. This study will determine the effectiveness of VRE therapy plus D-cycloserine at reducing PTSD symptoms in Iraq war veterans.

During this study, all participants will undergo one educational session and five VRE sessions. The first session will involve gathering information, learning common reactions to trauma, and participating in a breathing relaxation approach. The following five sessions will involve reviewing memories of Iraq and watching virtual Iraq sequences. Each participant will wear a head-mounted display during which they will view scenario settings such as cities, humvee convoys, and scenes related to combat. Participants will be randomly assigned to receive D-cycloserine, alprazolam (anti-anxiety drug), or placebo one half-hour before each VRE session.

Prior to the first treatment session, participants will undergo a startle reaction procedure. This will entail hearing sudden tones that last a fraction of a second, and viewing virtual reality scenes. Three small electrodes, attached to each participant's face, will measure the number of eye blinks during the procedure. At several times throughout the study, heart rate and skin conductance will also be measured with electrodes. Collection of saliva samples and measurement of blood pressure will also occur several times during this study. Before, during, and immediately after treatment, participants will complete questionnaires. Participants will be contacted 3, 6, and 12 months after treatment to assess symptoms and to schedule a time for an interview, additional questionnaires, and the virtual reality-based assessment.

Minimum age: 21 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Meets DSM-IV criteria for PTSD due to Iraq military trauma

- Speaks English

- Healthy overall

Exclusion Criteria:

- History of mania, schizophrenia, or other psychoses

- Suicidal

- Current alcohol or drug dependence

- Medication free within 2 weeks of study entry for any medication that has been taken

less than daily for the past month and medicine free within 4 weeks of study entry for any anxiolytic medication that has been taken daily for the last month or more

- Pregnant

- Special medical conditions, such as kidney insufficiency, chronic diseases, or

history of significant head injury

- Stabilized on potentially data obscuring medication such as glucocorticoids

Cathrine Arndt Jordan, MS, Phone: 404-712-8300, Email: carndt@emory.edu

Emory University, Atlanta, Georgia 30329, United States; Recruiting
Cathrine Arndt Jordan, MS, Phone: 404-712-8300, Email: carndt@emory.edu
Barbara O. Rothbaum, PhD, ABPP, Principal Investigator

Atlanta Veterans Affairs Medical Center, Atlanta, Georgia 30033, United States; Recruiting
Bekh Bradley, PhD, Sub-Investigator

Starting date: September 2006
Ending date: August 2011
Last updated: March 10, 2009