Designing, implementing and evaluating an evidence-based and trauma-informed mental health service integrated with a gynaecology service: a research protocol

Introduction

There are high rates of co-morbidity between mental health difficulties and gynaecological and female reproductive system disorders.¹ Several common gynaecological conditions are associated with high levels of psychological distress and impaired quality of life including endometriosis,² polycystic ovary syndrome,³ adenomyosis⁴ and chronic pelvic pain.⁵ The bidirectional link between pain and depressive symptoms is well-established.⁶

Reproductive events can also trigger or worsen psychiatric or psychological distress. The risk of new onset or relapse of mental disorder in the peripartum period is well-described in the literature. The provision of services for perinatal mental health within the Irish maternity system has improved radically in recent years, though much work is yet to be done to fully address unmet needs for maternal, paternal and infant mental health.⁷ Other reproductive transitions have received comparatively less attention. There are increased rates of depressive symptoms during the menopausal transition,⁸ particularly so for those who have experienced surgical menopause,⁹ which is pertinent to the provision of integrated mental healthcare for a gynaecology population.

Premenstrual disorders, which include premenstrual dysphoric disorder (PMDD) and premenstrual exacerbation of an underlying, usual mental health, disorder (PME), are an interface between psychiatry and gynaecology that warrant more robust attention as assessment and treatment can span both specialties. PMDD is a mental disorder, as defined in the Diagnostic & Statistical Manual of Mental Disorders (DSM-5) in 2013, where cyclical symptoms, such as irritability, low mood, anxiety and mood swings, occur in the luteal phase of the menstrual cycle and impact quality of life and functioning.¹⁰ It has a prevalence of about 3–8% of people with a menstrual cycle.¹¹ Differentiating PMDD from PME can be difficult¹² and many individuals are misdiagnosed with other mental disorders. Those with PMDD experience high rates of suicidality, with over one-third having attempted suicide in their lifetime.¹³ First-line treatments include the oral contraceptive pill or selective serotonin reuptake inhibitors (SSRI antidepressants) but third and fourth line treatments include inducing chemical or surgical menopause, which require the expertise of gynaecology.¹⁴ To ensure accurate diagnosis and appropriate management of complex cases, interdisciplinary working between psychiatry and gynaecology is essential.

Despite the needs described here, many modern medical services are fragmented, depriving individuals of holistic care and leaving illnesses that affect multiple systems under-treated. The WHO has stated that:

In Ireland, two core healthcare policy documents, the Sláintecare and Sharing the Vision reports, have defined greater integration of physical and mental healthcare as a key priority.^16,17 The existing inclusion health model has also emphasised the importance of integrated care and given consideration as to how that can be implemented (The Royal College of Physicians Ireland, 2026). Failure to provide integrated care disproportionally impacts the most marginalised groups in society. Likewise Sharing the Vision made a range of recommendations for the development of mental health services, and the importance of integrated care. While the majority are related to general services at primary and secondary care, there were two recommendations relating to Women’s Mental Healthcare.

Consultation-liaison psychiatry (CLP) is the sub-speciality of psychiatry that works at the interface between medical specialties and mental health. These services operate within acute general hospitals, although in Ireland, current resourcing levels fall short of national and international guidance.¹⁸ An important role of the consultation-liaison psychiatrist is to promote the integration of mental and physical healthcare.¹⁹

The three Dublin maternity hospitals include large gynaecology departments with a combined outpatient gynaecology attendance of over 40,000 appointments annually.^20–22 As these hospitals do not have access to a wider CLP service, there is no integrated mental health service available to this large population of gynaecology patients. This contrasts to the services available to women attending the maternity service in same hospital who can access the embedded perinatal mental health service during pregnancy and up to one year postpartum.²³ This also differs to the services available to patients attending general Model 4 and Model 3 hospitals for treatment of any physical health conditions who have access to the CLP services, and those who have gynaecological cancers who have access to the Psycho-Oncology Services which are integrated with cancer care in the eight Cancer Centres in Ireland. Members of this research group are currently completing a systematic review to consolidate the evidence base for the delivery of integrated mental healthcare with women’s health services.²⁴

This overview of service provision is outlined in Figure 1.

Figure 1. Services providing integrated mental healthcare in women’s health.

We will draw together the data from the literature to develop a model for the delivery of integrated mental and physical healthcare in the Women’s Hospitals and gynaecology hubs. Drawing on the examples of successful models in the Irish context such as the perinatal, psycho-oncology and the Beaumont pelvic floor services, we will pilot a stepped care model for delivering integrated mental healthcare via CLP in gynaecology services.

This study aims to answer the question: can an evidence-based and trauma-informed mental health service integrated with existing women’s health services be effective in improving health care outcomes for women?

Th research has the primary aim: to develop a framework for the integrated delivery of women’s mental and physical healthcare by identifying the needs, context, and existing services available in this area. It will support the development of evidence-based, trauma-informed mental health services to meet these needs and build a network of services and professionals to promote the development of these services and evidence-based interventions. This will comprehensively assess the needs, context, and existing services available in this area. It will develop a range of educational tools for clinicians working within gynaecology. It will provide proof of concept for evidence-based and trauma-informed mental health service (the EQUATE clinic) to meet the psychological needs of women attending a benign gynaecology clinic. It will design a bespoke integrated screening measure to identify and measure mental health needs, and to inform a tiered support system.

This project will have the following secondary aims:

Methods/Protocol

This study will assess the efficacy and acceptability of a clinical service pilot benign gynaecology clinic with assessment of patients, examining acceptability, engagement and outcomes.

This study will design and implement a pilot mental health service for pelvic pain in the benign gynaecology clinic. The service will assess patients, examine engagement, and assess outcomes. We envisage that this gynaecology and Consultation-Liaison Psychiatry (EQUATE) service would sit within the gynaecology hub at the Rotunda Hospital to facilitate integrated care. In the first instance, this service would aim to provide specialist input to patients with the conditions most in need of integrated care. This project will have two components: (a) screening and (b) service.

A) Screening

Robust screening is an important component of ensuring that the service is sustainable and reaches those who need it. Not everyone who has symptoms of depression or anxiety needs a psychiatrist, and many need support that is not necessarily at a specialist level. We will develop a screening service for the clinic similar to that provided by the IMPARTS service at King’s College Hospital London.^25,26 This service provides screening for all people attending medical outpatient clinics via a waiting-room screening tool. This is administered using an iPad and includes validated scales measuring symptoms of depression or anxiety. This study will implement a similar screening model for gynaecology clinics which will be matched to a tiered system for interventions as follows (see Figure 2):

• a) those with low levels of symptoms do not require intervention;

• b) Those with mild-moderate symptoms will receive sign-posting to the appropriate community supports, with a letter to their general practitioner and other professionals as necessary;

• c) Those with moderate-severe symptoms would be referred to the specialist EQUATE clinic;

• d) Those with evidence of acute risk or high levels of suicidality would be referred for emergency care.

Figure 2. Possible model for stepped care model based on screening tool, with potential matched interventions.

The system will identify those who require intervention and tailor the intervention to each woman’s needs. It will supply relevant information for those who require support for mild-to-moderate difficulties and share this information with their general practitioner and other professionals as necessary.

The following screening measures will be used (for those who proceed to the EQUATE clinic, these will be baseline measures used to assess change in clinical status over time):

• a) Depressive symptoms

We will measure depressive symptoms using the Patient Health Questionnaire (PHQ-9), a 9-item self-report questionnaire (range 0 to 27) with a score ≥ 10 having a high specificity and sensitivity for depressive disorder.²⁷

• b) Anxiety symptoms

To assess symptoms of anxiety, we will use the Generalised Anxiety Disorder 7-item scale (GAD-7), a 7-item self-report questionnaire (range 0–21) with a score ≥ 5 having a high sensitivity and specificity for at least mild anxiety disorder.^28,29

• c) Pain

The experience of pain will be assessed using the visual analogue scale (VAS). This simple measure asks respondents to rate their pain on a 100-mm line from 0 (no pain) to 10 (worst pain imaginable). It has been validated in gynaecology populations.^30,31

• d) Functioning

Functioning will be measured using the EQ-5D. The EQ-5D is a self-report measure of health-related quality of life across five dimensions: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. In addition, participants are asked to rate their current health on a scale from 0–100 (worst to best). The instrument allows for the calculation of quality-adjusted life years (QALYs).³²

• e) An endometriosis-specific outcome measure is required for the endometriosis

population. We will use the ENDOPAIN4D Questionnaire, a validated tool for measuring symptoms in endometriosis.³³ This four-dimensional structure has good internal consistency across the following domains: pain-related disability, painful bowel symptoms, dyspareunia, and painful urinary tract symptoms. These four subscores can be summed to obtain a total score ranging from 0 to 94.^34,35 The minimal clinically significant difference in the global score is 11.³⁶

We will assess the acceptability of the screening by including a question on their experience of the screening process.

Conclusions

This study will examine the feasibility and the acceptability of an integrated mental health and gynaecology service, and its associated embedded screening tool. The findings will shape further interventions to address the gap in integrated mind-body services for women.