An Exploration of the Mental Health impact among Menopausal Women: The MARIE Project Protocol

Menopause marks the end of the menstruation period which can incur naturally or due to surgery where the ovaries or the uterus is removed or the use of other treatments like chemotherapy. Menopause elicits both physiological and psychological changes such as joint or pelvic pain headaches or migraine cognitive function and mental health problems such as anxiety. In order to assess the mental health impact of menopause the physiological psychological and sociological composites need to be evaluated. It is increasingly recognised that the associated symptoms experienced by women and transmen are specific to menopause transition making it challenging to diagnose and treat using conventional methods. We developed a menopause tool called MenopAuse mental hEalth (MARiE) rating tool following a coproduction workshop. The MenopAuse mental hEalth (MARIE) projects overall aim is to explore the mental health impact of menopause through several work stream packages and assess the MARiE tool. The current work package (WP 2a and 2b) that is represented within this study aim to further explore menopause symptoms and then validate and determine the efficacy of the MARiE tool. We will conduct a prospective mixed methods study in the United Kingdom (UK) among women and transmen 18 years old that are perimenopausal, menopausal or postmenopausal. The quantitative portion will use the Hospital Anxiety and Depression Scale, Insomnia Severity Index Scale Menopause Rating Scale Greene Climacteric Scale Health related quality of life Quebec Pain Disability Scale and Burnout Assessment Tool in addition to the MARiE tool within the scope of WP2a and WP2b respectively. The qualitative component will use a topics guide. Research Ethics and Health Research Authority approval has been obtained with a reference of 22/EE/0159. The findings will be submitted for publication in peer-reviewed journals and presented at womens health primary care and mental health themed conferences. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This study did not receive any funding ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors