title: Evaluation of an antenatal acupuncture intervention as an adjunct therapy for antenatal depression (AcuAnteDep): study protocol for a pragmatic randomised controlled trial.
abstract: 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
  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.
  
  
  CONCLUSIONS
  Ethical approval was received in February 2015, and recruitment is underway and expected to be completed in July 2016.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry ACTRN12615000250538, Registered on 19 March 2015.
authors.affiliation: PhD Candidate, National Institute of Complementary Medicine, Western Sydney University, Building 5, Campbelltown Campus, Locked Bag 1797, Penrith, NSW, 2751, Australia. simone.ormsby@westernsydney.edu.au.
authors.forename: Simone M
authors.initials: SM
authors.lastname: Ormsby
authors.affiliation: Professor of Complementary Medicine, National Institute of Complementary Medicine, Western Sydney University, Building 5, Campbelltown Campus, Locked Bag 1797, Penrith, NSW, 2751, Australia. caroline.smith@westernsydney.edu.au.
authors.forename: Caroline A
authors.initials: CA
authors.lastname: Smith
authors.affiliation: Professor of Midwifery, Western Sydney University, Building EB, Parramatta Campus, Locked Bag 1797, Penrith, NSW, 2751, Australia. h.dahlen@westernsydney.edu.au.
authors.forename: Hannah G
authors.initials: HG
authors.lastname: Dahlen
authors.affiliation: Chair of Mental Health, Western Sydney University, Building 30, Campbelltown Campus, Locked Bag 1797, Penrith, NSW, 2751, Australia. p.hay@westernsydney.edu.au.
authors.forename: Phillipa J
authors.initials: PJ
authors.lastname: Hay
authors.affiliation: Associate Professor, Molecular Biology and Genetics, Western Sydney University, Building 30, Campbelltown Campus, Locked Bag 1797, Penrith, NSW, 2751, Australia. j.lind@westernsydney.edu.au.
authors.forename: Joanne M
authors.initials: JM
authors.lastname: Lind
mesh_terms: D015670:Acupuncture Therapy; D002985:Clinical Protocols; D003863:Depression / Q000628:therapy*; D005260:Female; D006801:Humans; D017063:Outcome Assessment, Health Care; D011247:Pregnancy; D011248:Pregnancy Complications / Q000628:therapy*; D011295:Prenatal Care; D011788:Quality of Life; D018045:Receptors, Oxytocin / Q000032:analysis; D018401:Sample Size
chemical_list: D018045:Receptors, Oxytocin