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  An-Fu Hsiao³  Teresa Calloway³  Andrea Gory Munoz³  Michael Hollifield³  Kala Carrick³  Karen Cocozza³  Christopher Reist³  Besa Smith⁴  Tyler Smith⁴ 

[1] Analydata;Department of Psychiatry and Behavioral Neurosciences, Wayne State University School of Medicine;Tibor Rubin VA Medical Center;UC Irvine Health Policy Research Institute;

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

DOI  :  10.1186/s13063-021-05394-3

来源: DOAJ

【 摘 要 】

Abstract Background Post-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. Methods This 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. Discussion The 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 registration ClinicalTrials.gov NCT02869646 . Registered on 17 August 2016.

【 授权许可】

Unknown