Evaluation of an antenatal acupuncture intervention as an adjunct therapy for antenatal depression (AcuAnteDep): study protocol for a pragmatic randomised controlled trial

BACKGROUND: Depressed pregnant women face difficulty navigating a course between the potentially serious consequences of leaving depression untreated and significant limitations associated with conventional therapies, such as foetal toxicity and teratogenicity. Preliminary evidence is suggestive that acupuncture may provide a safe and effective alternative treatment option for antenatal depression; however, additional research is required. The purpose of this study is to further investigate this treatment possibility, with an additional examination of a potential biomechanistic acupuncture effect. METHODS/DESIGN: In this pragmatic randomised controlled trial, we will compare individually tailored, flexible antenatal depression-oriented acupuncture with equivalent attention progressive muscle relaxation and routine antenatal depression hospital care. Eligible women at 24 weeks of gestation with Edinburgh Postnatal Depression Scale scores of 13 or more will be recruited from 2 antenatal clinics in South Western Sydney, Australia. The recruitment goal of 96 is powered to demonstrate a significant difference in Edinburgh Postnatal Depression Scale score severity between acupuncture and usual care, with intervention groups receiving weekly 1-h treatments for 8 weeks from 24 to 31 weeks of gestation. Mental health and quality-of-life assessments will occur at study commencement, intervention weeks 4 and 8 and 6 weeks post-natally via the collection of completed Edinburgh Postnatal Depression Scale scores, Depression, Stress and Anxiety Scale scores and World Health Organisation Quality of Life Scale scores. Adjustment to mothering will also be evaluated at 6 weeks post-natally using the Being a Mother Scale. A putative biomechanistic effect of acupuncture on the oxytocinergic system will additionally be examined by comparing baseline salivary hormone levels with those measured at intervention weeks 4 and 8, as well as leucocyte oxytocin receptor expression at baseline and intervention week 8. DISCUSSION: Ethical approval was received in February 2015, and recruitment is underway and expected to be completed in July 2016. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12615000250538, Registered on 19 March 2015. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1204-9) contains supplementary material, which is available to authorized users.