Title: Perinatal emotional skills groups for women with borderline personality disorder: a randomised feasibility trial
Funder: Department of Health and Social Care

Abstract: Research question Is it feasible and acceptable to undertake a trial of the effectiveness and cost-effectiveness of perinatal emotional skills groups for women with Borderline Personality Disorder (as an adjunct to standard care) compared with standard perinatal mental health care alone? Background? Borderline personality disorder (BPD) is a mental disorder characterised by emotional instability, impaired interpersonal functioning and increased risk of suicide. The perinatal period poses particularly difficult challenges for women with BPD and there is no clear evidence about how best to help them during this period. Emotional Skills Groups (ESGs) teach people how to deal with difficult emotions and can help people with BPD. Perinatal ESGs consist of twelve group sessions, targeting a woman s adjustment to motherhood. Prior observational research suggests that perinatal ESGs may help women with BPD. However, we do not know whether perinatal ESGs provide effective treatment and would like to conduct a trial to test this. Before we do this, a number of uncertainties in relation to trial design need to be addressed. Aims and objectives The aim of this study is to investigate whether it is feasible and acceptable to undertake a trial of the effectiveness and cost-effectiveness of perinatal ESGs for women with BPD (in addition to standard care) compared with standard perinatal mental health care alone. Specific objectives focus on feasibility of recruitment, eligibility criteria, randomising the intervention and the assessment battery. Methods We will randomise 48 women with a clinical diagnosis of BPD to receive ESGs in addition to standard perinatal mental health care, or to standard care alone. Women will be recruited from two centres and will be pregnant (from week 20 gestation onwards) or within 12 months of having a live birth. Feasibility outcomes will be: proportions of participants: (1) consenting; (2) completing baseline measures and randomised; (3) completing the intervention; (4) completing follow-up assessments. Self-reported outcome data will be collected at 2- and 4-months post-randomisation, including a rating scale for BPD, measures of emotional distress, parenting stress, health-related quality of life; offspring outcomes will be collected from records. At the end of the intervention, in depth interviews, focusing on acceptability of the intervention and research process, will be conducted with women who have completed treatment, study decliners, women who drop out of treatment and practitioners delivering ESGs. Progression criteria to a full trial will be based on traffic light criteria around recruitment, intervention uptake and completion of follow-up data. Timelines for delivery Months 1-4: set-up Months 5-17: recruitment and treatment Months 5-20: follow-ups Months 21-24: analysis and writing of HTA bid Anticipated impact and dissemination This study will assess the feasibility of conducting a definitive trial. If the definitive trial finds that ESGs are clinically effective and cost-effective, women with BPD will have greater opportunity to access effective help during the perinatal period. Enhancing the coping skills of women with BPD may also benefit the health of their children. We will disseminate our findings through published reports, social media, online conferences and via collaborative networks.

Lay abstract: People with a diagnosis of Borderline Personality Disorder have stormy relationships, and experience distressing changes in mood, as well as urges to harm themselves. Pregnancy, childbirth and becoming a parent are therefore particularly challenging experiences for women with Borderline Personality Disorder. Currently, we do not know the best way to help women with Borderline Personality Disorder during pregnancy and in the year after childbirth - a time that is referred to as the perinatal period. Emotional skills groups can help people to learn new skills in managing their feelings and relationships and these groups can relieve some of the symptoms of Borderline Personality Disorder. Members of our team have adapted emotional skills groups for women with Borderline Personality Disorder during the perinatal period. They involve twelve group sessions that are flexibly delivered and cover a range of topics about feelings and emotions, becoming a mother and the relationship with the baby. We know that perinatal emotional skills groups are popular with women with Borderline Personality Disorder, but we have not examined whether the groups provide an effective treatment. A clinical trial would help us to find this out. A clinical trial is a research project where we compare two or more treatments or therapies. Trials are important because they help us to find out whether a new treatment or therapy is better, or more effective, than what is currently provided as standard care. We are a group of clinicians, service users and researchers who want to find out whether a trial can be used to examine the effectiveness of perinatal emotional skills groups for women with Borderline Personality Disorder. In this study, we will offer perinatal emotional skills groups as an addition to standard care to half of the women, and the other women will be offered standard perinatal mental health care. Women will be invited to take part from South West England and London. Women who have used perinatal mental health services helped to plan this study and they will help us to ensure that we adopt the best and most sensitive methods for the future trial. They will also help us to share our findings with other members of the public. Until now, the needs of women with Borderline Personality Disorder during the perinatal period have largely been ignored by the health service. We believe that this study can help ensure that in future, these women are provided with more effective treatment. If shown to be effective, perinatal emotional skills groups could greatly increase the number of women with Borderline Personality Disorder who receive effective help during the perinatal period.

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