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Open Access Study protocol

Reducing depression during the menopausal transition: study protocol for a randomised controlled trial

Osvaldo P Almeida123*, Kylie Marsh12, Leon Flicker145, Martha Hickey6, Andrew Ford123 and Moira Sim7

Author Affiliations

1 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

2 School of Psychiatry & Clinical Neurosciences, University of Western Australia, 35 Stirling Highway, Crawley, WA 6009, Australia

3 Department of Psychiatry, Royal Perth Hospital, Perth, WA 6000, Australia

4 School of Medicine and Pharmacology, University of Western Australia, 35 Stirling Highway, Crawley, WA 6009, Australia

5 Department of Geriatric Medicine, Royal Perth Hospital, Perth, WA 6000, Australia

6 Department of Obstetrics & Gynaecology, University of Melbourne and Royal Women’s Hospital, Parkville, VIC 3052, Australia

7 School of Medical Sciences, Edith Cowan University, Joondalup, WA 6027, Australia

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Trials 2014, 15:312  doi:10.1186/1745-6215-15-312

Published: 6 August 2014

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/Design

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.

Discussion

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.

Trial registration

Australian and New Zealand Clinical Trials Registry ACTRN12613000724774. Date registered: 1 July 2013.

Keywords:
perimenopause; menopausal transition; depression; stress; anxiety; health promotion; prevention; randomised controlled trial