Virtual Reality and D-Cycloserine in Combat Related Psycological Trauma in Burn Service Members
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|ClinicalTrials.gov Identifier: NCT00855153|
Recruitment Status : Withdrawn (Investigator was not able to maintain IRB approval. Study never accrued subjects.)
First Posted : March 4, 2009
Last Update Posted : December 20, 2011
The purpose of this pilot study is to begin the examination of the feasibility of using Gradual Virtual Reality Exposure Therapy and D-Cycloserine (DCS) in the management of posttraumatic psychological symptoms in burned OIF/OEF military combatants.
The purpose of a feasibility study is to determine if there is clinical utility in this proposed treatment and to establish effective and safe treatment procedures. Given current literature, the following hypotheses are generated:
Hypothesis 1: Virtual Reality Exposure and D-Cycloserine medication (VRE + DCS learning pill) will result in clinically meaningful PTSD symptom reduction.
- SMs will attain scores that are lower than initial measures for symptoms of PTSD
- By the completion of VRE, Ss will attain scores in the sub-clinical range for measures of clinical depression Hypothesis 2: SMs will report greater life satisfaction following completion of VR+DCS treatment, as measured by scores on the Quality of Life Inventory (QOLI) when compared to pre-treatment scores
|Condition or disease||Intervention/treatment||Phase|
|Psychological Trauma||Other: VR (Virtual reality) Drug: D-Cycloserine||Not Applicable|
The purpose of this study is to establish systematic observations about the feasibility of using gradual exposure virtual reality treatment and D-Cycloserine (VRE + DCS) with service members receiving medical care for burns attained during combat. The rational for this study comes from the need to establish with this population, when and how VRE + DCS might be delivered in a safe and systematic fashion. This would be done in preparation for the potential of a future controlled study to address the efficacy of VRE + DCS in comparison to each component and control group.
This study seeks to establish methods of applying VRE + DCS in relation to medical viability as an attempt to clarify at what stage of medical care a service member is able to give informed consent, follow the proscribed instructions, and participate in VRE+ DCS process to include reasonable attention and capacity for immersion. Other areas that will be examined include medication suitability, expected course of medical treatment that would allow for reasonable completion of twelve sessions within twenty weeks, and assessed stability in social support.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Using Gradual Virtual Reality Exposure Therapy and D-Cycloserine (DCS) for Treatment of Combat Related Psychological Trauma in Burn Service Members|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
Subjects receive 50mg DCS prior to 90 min session with graded VRE treatment
Other: VR (Virtual reality)
VR stimulation of combat scenarios utilized as the exposure therapy tool.
Other Name: Iraq world II
50 mg DCS 30 min prior to individual 90 min session with graded VR exposure treatment
Other Name: DCS
- Reduction in PTSD symptoms for burn patients and improve perceived life satifaction. [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855153
|United States, Texas|
|US Army Institute of Surgical Research|
|Ft Sam Houston, Texas, United States, 78234|
|Principal Investigator:||Kathryn M Gaylord, RN, PhD||US Army Institute of Surgical Research|