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Pilot of Acupuncture to Improve Quality of Life in Veterans With Traumatic Brain Injury (TBI) and PTSD - NCT01060553-07018(Clinical Trial 493286)



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City:  East Orange
State:  
NJ
Zip Code: 07018
Conditions: Post-Traumatic Stress Disorders - Traumatic Brain Injury
Purpose: The purpose of this study is to examine if acupuncture improves Post-Traumatic Stress Disorder symptoms among veterans who participated in Operations Enduring Freedom and Iraqi Freedom. This study will also examine the degree of veteran acceptance for acupuncture.
Study summary: Project Background: Acupuncture can be effective for many of the specific co-morbidities that make up war-related Trauma Spectrum Disorder in both TBI and PTSD patients, including pain, stress and anxiety, insomnia, somatic and post-operative pain. Recent studies find very large effect sizes (Cohen's D .85 to 1.4). Thus, there is good reason to believe that acupuncture will induce recovery across a number of trauma spectrum dysfunctions in patients with TBI and PTSD, at low cost and with little risk. Project Objectives: The overall objective of this application is to determine the efficacy of adjunctive acupuncture for improving quality of life and function and alleviating co-morbidities associated with TBI and PTSD in service members injured in the current wars. The primary hypothesis of this study is: OIF/OEF veterans who screen positive for TBI or PTSD and are treated with a 12 week standard individualized acupuncture method will experience improved HRQL (as measured by the Veteran's SF-36) at 6, 12 and 24 week follow-up, compared to veterans randomly assigned to standard care alone. Project Methods: This is a pilot study on veterans who screen positive for TBI or PTSD in the VA healthcare record, which is being submitted to obtain additional pilot data, confirmation of recruitment strategies, information on non-participants and larger geographic coverage by including sites where the PI already has multisite collaborations. Frequency distribution and summary statistics for demographics and baseline variables will be presented by intervention group and for all subjects combined. Key demographic variables to be summarized are: age, gender, time to deployment, number of deployments, and diagnosis. Key baseline variables are: PTSD CAPS score, VSF-36, and ANAM score. This two arm pilot study will lead to a multisite study.
Criteria: Inclusion Criteria: - Diagnosis or positive screen test for PTSD and/or TBI. - Combat veterans of Operation Iraqi Freedom or Operation Enduring Freedom conflicts. Exclusion Criteria: - Unable to travel to East Orange VA for 12 consecutive weeks, biweekly for treatment. - Does not speak English. - Acupuncture or CBT treatment within the previous six months.
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Data Source: ClinicalTrials.gov
Date Processed: January 6, 2011
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