title: Reducing depression during the menopausal transition: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  The menopausal transition (MT) is a biological inevitability for all ageing women that can be associated with changes in mood, including depressive symptoms. There is tentative evidence that women who develop depression during the MT have greater risk of subsequent depressive episodes, as well as increased health morbidity and mortality. Thus, preventing depression during the MT could enhance both current and the future health and well-being of women. This study aims to test the efficacy of a client-centred health promotion intervention to decrease the 12-month incidence of clinically significant symptoms of depression among women undergoing the MT.
  
  
  METHODS
  This randomised controlled trial will recruit 300 women undergoing the MT living in the Perth metropolitan area. They will be free of clinically significant symptoms of depression and of psychotic or bipolar disorders. Consenting participants will be stratified for the presence of subsyndromal symptoms of depression and then randomly assigned to the intervention or control group. The intervention will consist of eight telephone health promotion sessions that will provide training in problem solving and education about the MT, healthy ageing, depression and anxiety, and management of chronic health symptoms and problems. The primary outcome of interest is the onset of a major depressive episode according the DSM-IV-TR criteria during the 12-month follow-up or of clinically significant symptoms of depression, as established by a score of 15 or greater on the Patient Health Questionnaire (PHQ-9). Secondary outcomes of interest include changes in the severity of symptoms of depression and anxiety (Hospital Anxiety and Depression Scale, HADS), quality of life (Short Form Health Survey, SF-12), and lifestyle.
  
  
  CONCLUSIONS
  Current evidence shows that depressive symptoms and disorders are leading causes of disability worldwide, and that they are relatively common during the MT. This study will use a multifaceted health promotion intervention with the aim of preventing depression in these women. If successful, the results of this trial will have implications for the management of women undergoing the MT.
  
  
  BACKGROUND
  Australian and New Zealand Clinical Trials Registry ACTRN12613000724774. Date registered: 1 July 2013.
authors.affiliation: Western Australian Centre for Health & Ageing (M573), Centre for Medical Research of the Perkins Institute for Medical Research, University of Western Australia, 35 Stirling Highway, Crawley, WA 6009, Australia. osvaldo.almeida@uwa.edu.au.
authors.forename: Osvaldo P
authors.initials: OP
authors.lastname: Almeida
authors.forename: Kylie
authors.initials: K
authors.lastname: Marsh
authors.forename: Leon
authors.initials: L
authors.lastname: Flicker
authors.forename: Martha
authors.initials: M
authors.lastname: Hickey
authors.forename: Andrew
authors.initials: A
authors.lastname: Ford
authors.forename: Moira
authors.initials: M
authors.lastname: Sim
mesh_terms: D002985:Clinical Protocols; D003863:Depression / Q000517:prevention & control*; D005260:Female; D006293:Health Promotion; D006801:Humans; D008593:Menopause / Q000523:psychology*; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D018401:Sample Size
references.citation: Menopause. 2010 Jul;17(4):815-22
references.pmid: 20616668
references.citation: Aust N Z J Psychiatry. 2010 Jun;44(6):513-9
references.pmid: 20482411
references.citation: Curr Opin Psychiatry. 2012 Nov;25(6):451-6
references.pmid: 22801360
references.citation: Maturitas. 2008 Sep-Oct;61(1-2):4-16
references.pmid: 19434875
references.citation: Menopause. 2008 Mar-Apr;15(2):223-232
references.pmid: 18176355
references.citation: Arch Gen Psychiatry. 2001 Jun;58(6):529-34
references.pmid: 11386980
references.citation: J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57
references.pmid: 9881538
references.citation: J Affect Disord. 2007 Nov;103(1-3):267-72
references.pmid: 17331589
references.citation: Climacteric. 2012 Feb;15(1):3-9
references.pmid: 22132727
references.citation: JAMA. 2004 Sep 22;292(12):1454-61
references.pmid: 15383516
references.citation: J Sci Med Sport. 2004 Apr;7(1 Suppl):6-19
references.pmid: 15214597
references.citation: Health Qual Life Outcomes. 2004 Sep 02;2:45
references.pmid: 15345062
references.citation: Arch Gen Psychiatry. 2012 May;69(5):493-8
references.pmid: 22566581
references.citation: Ann Intern Med. 2006 Apr 4;144(7):496-504
references.pmid: 16585663
references.citation: Am J Psychiatry. 2004 Dec;161(12):2238-44
references.pmid: 15569895
references.citation: Arch Gen Psychiatry. 2006 Apr;63(4):375-82
references.pmid: 16585466
references.citation: Int J Epidemiol. 2009 Feb;38(1):48-52
references.pmid: 18316347
references.citation: Arch Gen Psychiatry. 2006 Apr;63(4):385-90
references.pmid: 16585467
references.citation: Ann Fam Med. 2012 Jul-Aug;10(4):347-56
references.pmid: 22778123
references.citation: Expert Rev Neurother. 2007 Oct;7(10):1285-93
references.pmid: 17939767
references.citation: Acta Psychiatr Scand. 1983 Jun;67(6):361-70
references.pmid: 6880820
references.citation: Aust N Z J Public Health. 2002 Dec;26(6):508-10
references.pmid: 12530792
references.citation: Lancet. 2007 Sep 8;370(9590):859-77
references.pmid: 17804063
references.citation: Psychol Med. 2011 Sep;41(9):1879-88
references.pmid: 21306662
references.citation: Br J Obstet Gynaecol. 1997 Aug;104(8):923-33
references.pmid: 9255084
references.citation: J Clin Endocrinol Metab. 1996 Mar;81(3):1038-45
references.pmid: 8772573
references.citation: Womens Health (Lond). 2009 Sep;5(5):577-87
references.pmid: 19702456
references.citation: Asia Pac J Clin Nutr. 1994 Mar;3(1):19-31
references.pmid: 24351203
references.citation: Psychol Med. 2003 Jul;33(5):839-45
references.pmid: 12877398
references.citation: Best Pract Res Clin Obstet Gynaecol. 2007 Apr;21(2):275-92
references.pmid: 17166771
references.citation: J Psychosom Obstet Gynaecol. 1999 Mar;20(1):56-7
references.pmid: 10212888
references.citation: Maturitas. 2004 Aug 20;48(4):425-31
references.pmid: 15283935
references.citation: Ann Neurol. 2010 Oct;68(4):503-10
references.pmid: 20976769
references.citation: J Clin Psychol. 2010 Feb;66(2):201-14
references.pmid: 20049923
references.citation: Menopause. 2005 Jul-Aug;12(4):460-7
references.pmid: 16037762
references.citation: Lancet. 2005 Jul 30-Aug 5;366(9483):409-21
references.pmid: 16054942
references.citation: Lancet Oncol. 2012 Mar;13(3):309-18
references.pmid: 22340966
references.citation: J Gen Intern Med. 2001 Sep;16(9):606-13
references.pmid: 11556941
references.citation: Aust N Z J Psychiatry. 2003 Jun;37(3):362-73
references.pmid: 12780477
references.citation: Bull World Health Organ. 2001;79(11):1076-84
references.pmid: 11731817
references.citation: N Engl J Med. 2010 Sep 23;363(13):1245-55
references.pmid: 20860506
references.citation: Arch Intern Med. 2004 Feb 9;164(3):289-98
references.pmid: 14769624
references.citation: Am J Psychiatry. 2003 Jun;160(6):1147-56
references.pmid: 12777274