The protected time and resources under the KL2 funding provides didactic training and guidance from an interdisciplinary team to develop critical research skills and knowledge to develop as an independent researcher, and to facilitate collaborative work. The completion of a Masters of Public Health in Epidemiology is also a critical component to independence as a researcher. Hands-on experience in designing and implementing all phases of a clinical trial occurs through implementing a preliminary study into acupuncture intervention for persons with Traumatic Brain Injury (TBI). Disabilities related to TBI remain a sizeable public health concern, and there are gaps in the effectiveness of current rehabilitation methods. Post-traumatic headache, depression and cognitive difficulties are commonplace among TBI survivors, even in the late stages of recovery. Acupuncture decreases headache, depression, and improves cognition. This study is the initial step in determining the feasibility of evaluating acupuncture as a treatment for headache pain, depression, and cognitive difficulties in persons with chronic moderate TBI. The study consists of two phases. The initial phase will recruit ten community-dwelling participants of 18 years of age and older who were admitted and treated for moderate TBI at Harborview Medical Center within the past one to five years, and subsequently discharged and currently receive treatment for headache. Weekly Traditional Chinese Medicine (TCM) acupuncture intervention for 12 weeks will test specific elements of the protocol, recruitment, and retention. Focus group work with study participants will iteratively refine the acupuncture protocol, recruitment, and retention strategies. The second phase will recruit 30 community-dwelling participants (15 in each arm) as described. These participants will be randomized to the TCM acupuncture intervention or to continued standard of care. The participants will also receive weekly treatments for 12 weeks. Measurements of participant-reported instruments of headache pain and interference, depression and cognition will occur at baseline, at four weeks, eight weeks, and then post- intervention at 12 weeks. Feasibility outcomes included are: 1) ability to recruit persons with chronic moderate TBI, 2) acceptance of the participants to undergo randomization to acupuncture or to continued standard of care, 3) participant adherence of the intervention, 4) participant administrative burden for the outcome measures throughout 12 weeks. This award study will establish a foundation for indepdence as a researcher and for studies to optimize acupuncture interventions for TBI-related sequelae.
Headache, depression and cognitive difficulties are a significant problem among persons with chronic traumatic brain injury (TBI). There is a need to address gaps in clinical rehabilitation efforts and improve TBI-related outcomes for neurological, neuropsychological, and physical deficits. This project's overall aim is to determine the feasibility of evaluating acupuncture as a treatment for headache pain, depression, and cognitive difficulties in persons with chronic moderate TBI.
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