Pilot of Acupuncture to Improve Quality of Life in Veterans With TBI and PTSD
Condition: Post-traumatic Stress Disorders
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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, and information on non-participants . 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.
    

Intervention name(s): Acupuncture treatment
Intervention type(s): Other
Intervention description(s): This project was initially designed as a randomized trial with one group receiving treatment and the other wait list control, with delayed treatment. Due to extremely high dropout and cancellations and failure to return for post assessment, a midpoint assessment was added. Analysis was done on pre and post measures of all subjects who completed at least the midpoint assessment. Due to the very small number of subjects in the wait list control, the ones who completed 6 or 12 weeks of acupuncture after the wait list were combined with the few who completed the initial acupuncture for a pre-post single group analysis. for those who completed both the 6 and 12 week measures, the latest one was selected for analysis
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Post-traumatic stress disorders; Acupuncture; Quality of life; sleep disorder