Acupuncture for combat post-traumatic stress disorder: trial development and methodological approach for a randomized controlled clinical trial

Trials

Seth Norrholm¹  Tanja Jovanovic¹  Estate Sokhadze²  Andrea Gory Munoz³  Karen Cocozza³  Kala Carrick³  Teresa Calloway³  Michael Hollifield⁴  An-Fu Hsiao⁵  Christopher Reist⁶  Tyler Smith⁷  Besa Smith⁷ 

[1] Analydata, 3835 Centraloma Drive, 92107, San Diego, CA, USA;Department of Psychiatry and Behavioral Neurosciences, Wayne State University School of Medicine, 3901 Chrysler Service Drive, 48201, Detroit, MI, USA;Tibor Rubin VA Medical Center, 5109 E. 7th Street, 90822, Long Beach, CA, USA;Tibor Rubin VA Medical Center, 5109 E. 7th Street, 90822, Long Beach, CA, USA;The George Washington University School of Medicine and Health Sciences, Washington, DC, 2300 I Street NW, 20052, Washington, DC, USA;Tibor Rubin VA Medical Center, 5109 E. 7th Street, 90822, Long Beach, CA, USA;University of California at Riverside, 900 University Ave, 92521, Riverside, CA, USA;Tibor Rubin VA Medical Center, 5109 E. 7th Street, 90822, Long Beach, CA, USA;University of South Carolina School of Medicine – Greenville, 701 Grove Rd, 29605, Greenville, SC, USA;UC Irvine Health Policy Research Institute, 100 Theory, Suite 110, 92697, Irvine, CA, USA;

关键词: Post-traumatic stress;    Acupuncture;    Combat;    Veterans;    Psychophysiology;   

DOI  :  10.1186/s13063-021-05394-3

来源: Springer

【 摘 要 】

BackgroundPost-traumatic stress disorder (PTSD) is a significant public health problem, affecting approximately 7% of the general population and 13–18% of the combat Veteran population. The first study using acupuncture for PTSD in a civilian population showed large pre- to post-treatment effects for an empirically developed verum protocol, which was equivalent to group cognitive behavior therapy and superior to a wait-list control. The primary objective of this study is to determine both clinical and biological effects of verum acupuncture for combat-related PTSD in treatment-seeking US Veterans.MethodsThis is a two-arm, parallel-group, prospective randomized placebo-controlled clinical trial. The experimental condition is verum acupuncture and the placebo control is sham (minimal) acupuncture in 1-h sessions, twice a week for 12 weeks. Ninety subjects will provide adequate power and will be allocated to group by an adaptive randomization procedure. The primary outcome is change in PTSD symptom severity from pre- to post-treatment. The secondary biological outcome is change from pre- to post-treatment in psychophysiological response, startle by electromyographic (EMG) eyeblink. Assessments will be conducted at pre-, mid-, post-, and 1-month post-treatment, blind to group allocation. Intent-to-treat analyses will be conducted.DiscussionThe study results will be definitive because both clinical and biological outcomes will be assessed and correlated. Issues such as the number needed for recruitment and improvement, use of sham acupuncture, choice of biological measure, and future research need will be discussed.Trial registrationClinicalTrials.gov NCT02869646. Registered on 17 August 2016.

【 授权许可】

CC BY