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| Descriptive Information Fields | |||||
| Brief Title † | Effectiveness of Virtual Reality Exposure Therapy and D-Cycloserine to Treat Iraq War Veterans With Post-Traumatic Stress Disorder | ||||
| Official Title † | A Cognitive Enhancer May Facilitate Behavioral Exposure Therapy for Veterans With PTSD | ||||
| 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. |
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| 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. |
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| Study Phase | Phase II, Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Psychophysiological measures [ Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups ] [ Designated as safety issue: No ] PTSD Symptom Scale Self-Report [ Time Frame: Measured at pre- and post-treatment and at Months 3, 6 and 12 follow-ups ] [ Designated as safety issue: No ] Clinical Global Impressions Scale [ Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups ] [ Designated as safety issue: No ] Quality of Life Inventory [ Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups ] [ Designated as safety issue: No ] State-Trait Anxiety Inventory [ Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups ] [ Designated as safety issue: No ] Beck Depression Inventory [ Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups ] [ Designated as safety issue: Yes ] |
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| Condition † | Stress Disorder, Post Traumatic | ||||
| Intervention † | Drug: D-Cycloserine Drug: Alprazolam Behavioral: Virtual Reality Exposure Therapy Drug: Placebo |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 150 | ||||
| Start Date † | September 2006 | ||||
| Completion Date | August 2011 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00356278 | ||||
| Organization ID | R01 MH070880 | ||||
| Secondary IDs †† | DATR AD-TS | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | February 2008 | ||||
| First Received Date † | July 24, 2006 | ||||
| Last Updated Date | February 27, 2008 | ||||
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