Title: The COSI study: a multi-site RCT to explore the clinical and cost effectiveness of the Circle of Security Intervention for mothers in perinatal mental health services
Funder: Department of Health and Social Care

Abstract: 1 in 5 of women experience mental illness in pregnancy or the first year after birth. Seven percent of these women (45,000) in England experience complex and severe mental illness (such as bipolar disorder, complex post traumatic stress disorder) and receive specialist support from NHS community perinatal mental health services (PMHS). If such mental illness is left untreated, it can make it difficult for mothers to parent their new infant, and in England it costs over £8 billion each year, with most of these costs relating to the impact on their child’s development._x000D_ _x000D_ PMHS provide a range of support for women with mental illness, but there are still gaps in the research and therefore in the therapies that are offered. These gaps are in two main areas: (a) group therapy approaches; and (b) parent-infant bonding therapies that are adapted to the needs of women with mental illness. Women using PMHS told our research group that they would like to have more support with both these areas. Some PMHS have started innovating to fill these gaps and one intervention that is showing preliminary efficacious findings that patients report finding helpful is ‘Circle of Security’ (CoS)._x000D_ _x000D_ CoS is a brief, 8-session group therapy programme that is delivered over 10 weeks and was developed in America. CoS is designed to help parents understand more about their babies and their emotional states, as well as manage their own difficult emotions and how they may affect their relationship with their babies. The group environment encourages peer support. A number of previous research studies have explored the effectiveness of CoS with parents of children of various ages and these show that mothers find it a helpful approach that improves their mental health and their relationship with their children. However, these research studies have been poor quality and there has never been a research trial in England or in a PMHS._x000D_ _x000D_ In our study we want to test how effective CoS is in improving symptoms of maternal mental illness, and the quality of parents’ bond with their babies in a group of 369 women using PMHS and experiencing high levels of bonding difficulties with their babies. We also want to find out if CoS offers good value for money. We plan to do this by carrying out a large trial in 9 NHS PMHS in England. We will divide women into two groups at random to either receive CoS alongside standard care in a PMHS or to receive standard care only. We will then compare women's mental health symptoms and parent-infant bonding levels at the beginning of the trial, 3-months later (when one group of the women will have received the CoS group) and then 7- and 12-months after the women first joined the trial. We will also interview women to find out their views of receiving CoS._x000D_ _x000D_ The proposed research has received feedback from a group of experts by experience who have used a PMHS, to ensure it is adapted and relevant to their needs._x000D_ _x000D_ If funded, this will be the first large study to test whether a brief group therapy intervention is effective for women using PMHS in improving symptoms of their mental illness and the quality of their bond with their babies. It addresses an area of key concern to women, families and the NHS and is an opportunity to reduce the burden of its long term effects. If shown to be effective the intervention could be delivered widely across the NHS in PMHS.

Lay abstract: Research question: Is the Circle of Security-Parenting (COS-P) intervention more effective than treatment as usual in improving symptoms of maternal mental illness and mother-infant bonding for mothers in NHS perinatal mental health services? _x000D_ _x000D_ Background: Perinatal mental health services (PMHS) provide multi-disciplinary support for women with mental illness in pregnancy and the first postnatal year. However there are still large gaps in provision, particularly in (a) group therapy approaches; and (b) parent-infant bonding therapies. One intervention showing preliminary efficacious findings and user acceptability is COS-P. COS-P consists of a brief, 8-session group programme delivered over 10 weeks. The intervention is designed to help parents understand more about their babies, as well as manage their own difficult emotions and how they may affect their relationship with them. A number of previous research studies have explored the effectiveness of COS-P and found that in addition to mothers finding the group approach helpful, improvements were also made in their mental health and relationship with their children. However, these research studies have been poor quality and there has never been a research trial in England or in a PMHS. _x000D_ _x000D_ Aims and objectives: The aim of the research is to conduct a Randomised Control Trial (RCT) to test whether COS-P will reduce maternal mental health symptoms in mothers accessing NHS community PMHS compared to treatment as usual (TAU). Secondary objectives include exploring whether the intervention improves maternal sensitivity, emotion regulation skills, attachment security and has an impact on infant development. Additionally, the project aims to examine whether the intervention is acceptable to participants and NHS staff, and whether it is cost-effective or not. _x000D_ _x000D_ Methods: An internal pilot study will first be carried out to ensure that a main trial is feasible. A multi-centre RCT will then be carried out in nine NHS PMHS in England with a sample size of 369 participants. Participants will be randomised to the intervention-COS-P plus TAU or to the control group, which will consist of TAU. Maternal psychopathology as measured by the CORE-OM (primary outcome) will be measured at the beginning of the trial (baseline), 3-months (after the intervention group has finished) and at 7- and 12-months after baseline. A suite of secondary outcomes will also be collected. Service use and quality of life measures will also be collected alongside a process evaluation of women’s and therapists’/practitioners’ views and experiences. _x000D_ _x000D_ Timelines for delivery: The trial set up phase will last approximately six months. Recruitment will follow until month 30, data collection will continue until month 42, with the last 6 months involving data analysis, write-up and dissemination work. _x000D_ _x000D_ Anticipated impact and dissemination: This will be the first large study to test whether COS-P is effective for women using PMHS in improving symptoms of their mental illness and the quality of their bond with their babies. It addresses an area of key concern to women, families and the NHS and is an opportunity to reduce the burden of the long-term intergenerational effects of mental illness. If shown to be effective the intervention could be delivered widely across the NHS. The research team has a strong track record of dissemination; results will be shared widely with families, organisations and professionals in the field.

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