Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00356278
Status:
COMPLETED
Last Update Posted:
2016-01-08
First Post:
2006-07-24
Brief Title:
D-cycloserine and Virtual Reality Exposure to Treat Iraq War Veterans With PTSD
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
A Cognitive Enhancer May Facilitate Behavioral Exposure Therapy for Veterans With PTSD
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 participants 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
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 participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH070880 | NIH | Other | httpsreporternihgovquickSearchR01MH070880 |
| DATR AD-TS | OTHER | None | None |