Clinical trial NCT00356278: D-cycloserine and Virtual Reality Exposure to Treat Iraq War Veterans With PTSD
Official title: A Cognitive Enhancer May Facilitate Behavioral Exposure Therapy for Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Stress Disorder, Post Traumatic
Keywords: D-Cycloserine
Virtual Reality
Exposure Therapy
Veterans
Cognitive Behavior Therapy
Translational Research
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-07-25
Enrollment: 156
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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

Primary outcomes:
measure: Clinician-Administered PTSD Scale (CAPS)
timeFrame: Baseline
measure: Clinician-Administered PTSD Scale (CAPS)
timeFrame: Posttreatment, 8 weeks
measure: Clinician-Administered PTSD Scale (CAPS)
timeFrame: Month 3
measure: Clinician-Administered PTSD Scale (CAPS)
timeFrame: Month 6
measure: Clinician-Administered PTSD Scale (CAPS)
timeFrame: Month 12
Secondary outcomes:
measure: PTSD Symptom Scale Self-Report
timeFrame: Baseline
measure: PTSD Symptom Scale Self-Report
timeFrame: Posttreatment, 8 weeks
measure: PTSD Symptom Scale Self-Report
timeFrame: Month 3
measure: PTSD Symptom Scale Self-Report
timeFrame: Month 6
measure: PTSD Symptom Scale Self-Report
timeFrame: Month 12
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Barbara O. Rothbaum, PhD, ABPP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rauch SAM, Koola C, Post L, Yasinski C, Norrholm SD, Black K, Rothbaum BO. In session extinction and outcome in Virtual Reality Exposure Therapy for PTSD. Behav Res Ther. 2018 Oct;109:1-9. doi: 10.1016/j.brat.2018.07.003. Epub 2018 Jul 20.
citation: Norrholm SD, Jovanovic T, Gerardi M, Breazeale KG, Price M, Davis M, Duncan E, Ressler KJ, Bradley B, Rizzo A, Tuerk PW, Rothbaum BO. Baseline psychophysiological and cortisol reactivity as a predictor of PTSD treatment outcome in virtual reality exposure therapy. Behav Res Ther. 2016 Jul;82:28-37. doi: 10.1016/j.brat.2016.05.002. Epub 2016 May 7.
citation: Rothbaum BO, Price M, Jovanovic T, Norrholm SD, Gerardi M, Dunlop B, Davis M, Bradley B, Duncan EJ, Rizzo A, Ressler KJ. A randomized, double-blind evaluation of D-cycloserine or alprazolam combined with virtual reality exposure therapy for posttraumatic stress disorder in Iraq and Afghanistan War veterans. Am J Psychiatry. 2014 Jun;171(6):640-8. doi: 10.1176/appi.ajp.2014.13121625.