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Effectiveness and Patient Acceptability of Stellate Ganglion Block (SGB) for Treatment of Posttraumatic Stress Disorder (PTSD) Symptoms Among Active Duty Military Members
Technical Report,01 Mar 2015,29 Feb 2016
Research Triangle Institute Research Triangle Park United States
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This study seeks to evaluate the effectiveness and acceptability of stellate ganglion block SGB for treatment of Posttraumatic Stress Disorder PTSD symptoms. We will conduct two parallel studies a randomized, controlled trial RCT to evaluate the effectiveness of SGB for treating PTSD, and a qualitative study to determine the degree to which the procedure is deemed acceptable by active duty service members with PTSD, their spouses, and their providers. A total of 240 individuals will be enrolled for the RCT portion of the study qualitative study participants will be convenience sampled from among the RCT participants. For the RCT study, participants will be randomized 21 active SGB to sham across three study sites. Participants will receive the study condition active or sham at weeks 0 baseline and 2, and assessments will be conducted at weeks 0, 2, 4, 6, and 8. For the qualitative study, individuals enrolled in the RCT will be asked to participate either in a focus group or an interview with their spouse. In addition, we will conduct focus groups and key informant interviews with providers those who refer individuals to the study, and those who provide SGB to service members.
APPROVED FOR PUBLIC RELEASE