Title: Perinatal Mental Health
Funder: Department of Health and Social Care

Abstract: Perinatal mental health research programme 1.The effectiveness of perinatal mental health services: There is growing evidence that many women experience mental disorders in pregnancy and the postpartum period, and these are associated with, not only considerable morbidity and mortality for women, but also prematurity and low birth weight infants, deficits in maternal-infant interaction, and adverse cognitive and emotional outcomes in children. Perinatal mental health services include identification and treatment in primary care and maternity services, and specialist secondary and tertiary care, including psychiatric Mother and Baby Units, for women with severe mental disorders. There has been no previous research into the effectiveness and cost-effectiveness of current models of care in the UK. As Chief Investigator of an NIHR Programme Grant for Applied Research on the Effectiveness and cost-effectiveneSs of perinatal Mental health servIces (ESMI) (pending contract; start date 1st april 2013), I and a multi-disciplinary team of co-applicants and collaborators, aim to: a. establish the most effective ways to identify depression in maternity services by estimating the specificity, sensitivity and positive predictive value of the currently used 2 question screen and an internationally used screening tool in pregnancy and in the postpartum period (the Edinburgh Postnatal Depression Scale) using a diagnostic “gold standard” measure; b. provide up to date evidence on the prevalence of common mental disorders during the first trimester using a crosssectional survey at the time of antenatal booking; c. investigate the efficacy of Guided Self Help (a low intensity psychological intervention) modified for women with mild to moderate depression in pregnancy in an exploratory RCT; d. explore women’s experiences of different service models including psychiatric Mother and Baby Units and Crisis Resolution Teams using a qualitative study design; e. investigate the effectiveness and cost-effectiveness of different service models including psychiatric Mother and Baby Units, general inpatient wards and Crisis Resolution Teams in a national cohort study. This will allow us to make recommendations to policy makers, NHS commissioners and providers about the type of perinatal mental health services that are most effective. 2. Obesity and Mental Health in pregnancy: Obesity is a well recognised risk factor for many pregnancy complications including preeclampsia, gestational diabetes, emergency caesarean section and intrauterine death. Sixteen percent of women were obese at the start of pregnancy in 2004, compared with 9.9% in 1990, and obesity in continuing to increase in prevalence in pregnancy. Obesity has also recently emerged as a significant indirect cause of maternal mortality in the 2011 Confidential Enquiry into Maternal Deaths. There is little information on the relationship between overweight/obesity and mental disorders during pregnancy. I am supervising (with Lucilla Poston at KCL, second supervisor) a MRC PhD studentship for Emma Molyneaux; 2012-2015. This PhD project therefore aims to investigate firstly, whether overweight/obese pregnant women are at significantly increased risk of depression and anxiety disorders compared with normal weight pregnant women. Secondly, whether overweight/obese pregnant women with depression and/or anxiety compared with obese/overweight pregnant women without depression or anxiety have: a) significantly poorer quality diets, lower rates of physical activity, higher rates of smoking and alcohol use, and higher rates of excessive gestational weight gain b) higher rates of pregnancy complications, including preeclampsia, pre-term labour and admissions to neonatal units c) have a poorer response to weight management interventions in pregnancy These research questions will be investigated by systematic reviews including an individual patient data metaanalysis, and by analyses of international cohorts (ALSPAC, SCOPE, UPBEAT, EU funded collaborative programme on Early Nutrition). This research will inform maternity services and policy makers about the outcomes of obese pregnant women with mental disorders and inform care of this vulnerable group of women. We are also supporting an ACF (Lindsay Banham) in preparing a training fellowship application investigating whether obesity in pregnancy is associated with adverse childhood mental health outcomes at 3 years of age. 3. Bipolar disorder in pregnancy: Women with bipolar disorder face difficult decisions regarding the risks and benefits of prophylactic medication in pregnancy and the early postpartum period when they are at particularly high risk of a relapse. I am primary supervisor (with Ian Jones, University of Cardiff, second supervisor) of a PT PhD studentship for Clare Dolman; 2010-2016. Clare is investigating the information needs of other women with bipolar disorder planninga pregnancy or who are pregnant, using a qualitative study design, to inform the development of a decision aid which will be evaluated in a future RCT. 4. Antipsychotics in Pregnancy: There is very limited information about the risks and benefits of psychotropic medication in pregnancy for women with a history or current severe mental illness. Information on the risk of relapse in pregnancy for different diagnoses is not known - some research suggests pregnancy is protective but other work suggests that women with bipolar disorder who stop prophylactic medication are at a two-fold risk of relapse in pregnancy (though this study had a sample size of 89 only), and the risk of relapse postpartum is considerably higher with risk ratios of 23 reported. There has been even less published on rates of relapse for women with schizophrenia. Such information is critical for women to make informed decisions on medication, as being medication free in pregnancy can result in relapse, suicide or, rarely, infanticide, but medication may increase the risk of congenital malformations, maternal complications (e.g. an association with gestational diabetes has been recently reported in women taking antipsychotic medication) and adverse fetal outcomes. These studies have had limited information on possible confounders when investigating the relationship between medication and adverse outcomes and we have a unique data source with rich clinical data which could help add to the evidence base in this area. We aim to investigate: a) the risk of, and time to, relapse during pregnancy, and in the postpartum period, after stopping psychotropic medication compared with continuing and switching medication, in pregnant women with a history of psychosis; b) compare maternal, fetal and neonatal outcomes for different types of antipsychotic medications used through pregnancy. We will use a historical cohort study design, utilising secondary care data, primarily the NIHR (BRC-MH) Mental Health Biomedical Research Centre’s South London and Maudsley Case Register Interactive System (CRIS). CRIS allows searching and retrieval of anonymised information from the Patient Journey System (PJS), which contains all electronic clinical records of patients cared for by the South London and Maudsley (SLaM) NHS Mental Health Trust. These are secondary mental health care records consisting of electronic case notes of around 200,000 people, serving a source population of about 1.2 million people across four London boroughs, and national tertiary referral services including a national perinatal mental health service. CRIS has recently been linked with Hospital Episode Statistics (HES) which includes maternity data. Hospital Episode Statistics (HES) provide national statistical data for care provided by NHS hospitals and NHS hospital patients treated elsewhere in England. They include information on inpatient admissions and outpatient appointments including delivery episodes and other obstetric procedures and appointments as well as midwifery, antenatal assessment dates and other maternity data, and will enable us to examine obstetric outcomes (e.g. gestational diabetes). We will also link the maternity and mental health data to local neonatal data (collected using standardised methods for upload onto the national Badger database) and thus also investigate neonatal outcomes. This is therefore a unique source of data with much richer secondary care clinical data than the administrative registers or primary care datasets used in previous research. To date, using pilot funding available until August 2013 provided by Tommy's Baby Charity through support from Johnson and Johnson, we have run a series of searches to identify pregnant women with bipolar disorder or schizophrenia and related disorders (who may or may not have taken antipsychotics or mood stabilisers during pregnancy). Our search strategy has utilised CRIS to identify diagnoses (using ICD-10 codes) and the linkage with HES to identify incidences of pregnancy. We have established a cohort of >500 women: 261 with schizophrenia and related disorders and 246 with affective psychoses and have started data extraction (650 total pregnancies). By August 2013 we will have extracted clinical and socio-demographic data for our cohort using text mining software (developed by the General Architecture for Text Engineering (GATE) research team, Sheffield University). We have agreement from lead clinicians to link data from CRIS with local neonatal databases from each local general hospital where CRIS women and their infants will have had care. SLaM have set up the Clinical Data Linking Service which is run by the Caldicott guardian and is used as a trusted third party. HES and Primary Care linkages have passed NIGB security criteria and are using this service. The cost of this linkage is included in the BRC-MH budget. Funding through the NIHR Research Professorship would provide resource for a clinical lecturer to extract maternity and neonatal data and analyse predictors of maternal, fetal and infant outcomes, after adjustment for confounders (e.g. maternal age, smoking, pre-pregnancy BMI, other medications, alcohol/substance misuse, severity of illness, deprivation). These outcomes include - a. severe relapse/exacerbation of symptoms and time to relapse during pregnancy or postpartum (inpatient admission or transfer to Home Treatment Team services (intensive home treatment for acutely ill patients) due to worsening of illness); b. time to relapse during pregnancy or postpartum (and consequent increases in medication exposure to the fetus); c. maternal adverse effects e.g. gestational diabetes, obstetric complications (placental abruption, placenta previa, intra-uterine growth restriction, preeclampsia, hypertension, antepartum and postpartum haemorrhage; d. pregnancy outcome e.g. elective termination of pregnancy, intrauterine death, stillbirth, ectopic, live birthe. perinatal morbidity and mortality eg spontaneous and iatrogenic preterm birth (= 90th centile, APGAR score, ventricular haemorrhage, respiratory distress syndrome, persistent pulmonary hypertension, hypoglycaemia, stillbirths, neonatal deaths. Our findings will contribute to the evidence base for women with severe mental disorders and their psychiatrists to inform decision making on medication in pregnancy. 5. Improving perinatal outcomes amongst women with complex social factors: Complex social factors, including substance misuse, being a refugee, mental disorders, socio-economic deprivation, domestic violence, lack of partner support and young age, are associated with poor pregnancy outcomes for women and their babies. NICE has identified that further research is required to determine which service models improve outcomes for women with complex social factors. I will therefore build on my research on smoking cessation in pregnant women with mental disorders and the impact of domestic violence in pregnant women with mental disorders, and join maternity service researchers at the Women’s Health Academic Centre, to develop and evaluate a model of care for women with complex social factors. This development work will include a systematic review, piloting of the intervention and use of subsequent stages of the MRC framework for evaluation of complex interventions. We are planning to submit an NIHR Programme Development Grant in April 2013; CI Prof Sandall, KCL). Violence and Victimisation 1. Optimising the NHS response to trafficked people (NIHR PRP programme): Human trafficking is the recruitment and movement of individuals – most often by force, coercion or deception – for the purpose of exploitation. Trafficked women, men and children frequently experience extreme physical, psychological and sexual violence and social marginalisation. Many suffer acute and longer-term health problems and healthcare challenges. NHS staff have an essential role in identifying and referring trafficked people to other services and receiving and treating people referred for healthcare, yet there is extremely limited evidence to inform NHS responses. Anecdotal reports from posttrafficking services, law enforcement and a few provider studies suggest that trafficked people have difficulty accessing healthcare and providers do not feel equipped to identify and provide appropriate care for trafficked people. The proposed research aims to improve the identification and referral of trafficked people and enable NHS healthcare professionals to provide safe and appropriate care to meet their health needs. Our research programme will: a. collect evidence on the number of trafficked adults and children identified and using NHS services in England using national surveys; b. collect data on the healthcare needs of trafficked people using a cross-sectional survey of trafficked people cared for by NGO support services or in the NHS; c. use semi-structured interviews with trafficked people on their experiences and use of the NHS; d. use semi-structured interviews with healthcare professionals on their experiences and challenges in caring for trafficked people; e. identify gaps in the knowledge of relevant healthcare professionals about trafficked people’s health care needs using a knowledge questionnaire administered to professionals at mandatory safeguarding training session; f. carry out a historical cohort study using the BRC-Mental Health CRIS system described above to compare pathways to care and outcomes in trafficked people and a matched comparison cohort; g. provide recommendations, materials and dissemination strategies to support NHS staff to identify, refer and care for trafficked people; We started this research this year and have submitted a paper reporting on the health needs of trafficked men using data from a support service for migrants. We have also identified, using CRIS, 135 trafficked people that have been in contact with SLaM services and have started to extract data on their referral pathways into care and their mental health outcomes. We are currently preparing a REC application for the rest of the planned studies and will begin data collection in July 2013. This research programme will directly inform health policy on trafficked people and the future training of front line staff. 2. Safety in Sexual Relationships: People with severe mental illness experience a range of difficulties in the area of sexual health including sexual dysfunction, difficulties finding and maintaining intimate sexual relationships, sexual exploitation, partner violence, sexual risk taking, higher rates of unplanned pregnancy, and increased risk of HIV and other sexually transmitted diseases. I am collaborating with colleagues in planning a programme of research which will include a lifestyle survey and qualitative interviews related to sexual health and relationships of people with severe mental disorders in NHS mental health services, development and evaluation of an intervention designed to promote sexual health and well-being and reduce sexual risk behaviour, and a pilot multi-centre RCT. We have recently submitted an NIHR Programme Development Grant (CI Dr Hughes, University of York; co-applicants include Prof Johnson UCL; Prof Gilbody, University of York). This PDG (and a future PGfAR) would build on my NIHR funded work on how community mental health teams can address domestic violence, by integrating our piloted intervention with abehavioural intervention (to be developed and evaluated during the PDG and PGfAR) which addresses these other aspects of sexual risk behaviour, with the aim of improving the sexual health of people with severe mental disorders.

Lay abstract: Mental health problems in pregnancy and the postpartum period have potential adverse consequences for women, their infants and their families. Professor Howard’s research aims to contribute to the evidence base on effective and safe ways of treating mental health problems in the perinatal period. Her research will include studies on the risks and benefits of medication, and the effectiveness and cost-effectiveness of complex non-pharmacological interventions.

Research activity codes: 6.1 PHARMACEUTICALS;6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH;REPRODUCTIVE HEALTH AND CHILDBIRTH