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

Abstract

BackgroundThe 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/DesignThis 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.DiscussionCurrent 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 registrationAustralian and New Zealand Clinical Trials Registry ACTRN12613000724774. Date registered: 1 July 2013.

Quality of life among postmenopausal women enrolled in the Minnesota Green Tea Trial

“…All of these factors may interact to facilitate the development of depressive symptoms during the menopause transition. [11] The transition through menopause can be a challenging and difficult time with many co-factors that exacerbate anxiety and depression, therefore, clinicians need to be alert to the conditions and provide an environment where discussion and referral for psychological support can be considered to manage symptoms.…”

The prevalence of depression and anxiety in premenopausal and menopausal women: A cross‐sectional study

“…26 In terms of the limitations of this research, while the Beck questionnaire is a valuable resource for assessing the prevalence and intensity of depression and anxiety, it may not be an appropriate tool for differentiating between anxiety and depression within the general population. 27 Our study only considered women who reported experiencing natural menopause, thus our results may not be generalizable to women who undergo menopause through surgical intervention or other causes.…”

“…In terms of the limitations of this research, while the Beck questionnaire is a valuable resource for assessing the prevalence and intensity of depression and anxiety, it may not be an appropriate tool for differentiating between anxiety and depression within the general population. 27 …”