Title: Low intensity interventions for antenatal depression: A feasibility study of an RCT of Interpersonal Counselling compared to Cognitive Behavioural Therapy.
Funder: Department of Health and Social Care

Abstract: Background Around 12% of women experience antenatal depression with known to be adverse effects on future child development. Currently in the NHS low intensity six-session cognitive behavioural therapy (CBT), provided by Psychological Wellbeing Practitioners (PWPs) who have a basic level of training, is the main treatment offered for mild to moderate depression during pregnancy. Trained psychological therapists provide the high intensity interventions. CBT focuses on thoughts and behaviours that trigger and maintain depression. However CBT has no specific relevance to pregnancy, relying on the skills of the practitioner to adapt to the specific circumstances of the individual. In contrast, Interpersonal Counselling (IPC) focuses on relationship problems as central to the onset and maintenance of depression including the impact of changes in role and of loss (such as a previous miscarriage). It is a clearly manualised approach with explicit tasks to undertake. The model is highly relevant to the perinatal period and less reliant on the skill of practitioners to adapt to the circumstances of the individual. We argue that as CBT is not specifically relevant to the perinatal context, its effectiveness in practice for treating antenatal depression is poor and the main reason for the low rates of treatment completion. We hypothesise that as IPC is more relevant to pregnancy, it will be more effective and cost-effective for treating antenatal depression than low intensity CBT. Aim and question to be addressed Is a trial to examine effectiveness and cost-effectiveness of IPC compared to low intensity CBT for mild to moderate depression during pregnancy feasible and acceptable? Plan of investigation We will randomise 12 low intensity practitioners and 4 supervisors working in NHS psychological treatment services to receive training in IPC or booster training in CBT. This will be evenly split across two centres, Bristol and Exeter. 60 women with mild to moderate depression (ICD 10 criteria according to the revised Clinical Interview Schedule) will be recruited (30 at each site) at midwife clinic appointments and ultrasound scanning appointments. Women between 10 and 18 weeks of pregnancy and meeting criteria for mild to moderate depression will be randomised to receive six sessions of IPC or CBT from the trained practitioners. Outcomes will be collected by telephone 12 weeks following randomisation. These will include the Edinburgh Depression Scale, relationship measures and health economic measures. The number of sessions attended, number including the partner, whether step up to more intense psychological intervention is needed, use of medication and use of secondary mental health services will also be recorded. In depth interviews will be conducted with 1) women who have completed IPC (10-12 women) or CBT (5-6 women) and 2) their partners focusing on the acceptability and perceived effectiveness of the talking therapy. Interviews will also be conducted with 3) study decliners, where possible, to understand ways in which participation might be supported and 4) practitioners in the IPC arm, their supervisors and midwives, at the end of the intervention to focus on the acceptability, strengths and weaknesses of the intervention and recruitment process. The potential benefits to patients will be the provision of a relevant psychological treatment that is more likely to be completed and thus reduce the impact of depression on pregnant women and their families. The NHS would benefit as with relatively simple training, low intensity practitioners can provide a relevant and inexpensive treatment, increase provision of treatment to perinatal women, enhance skills of practitioners and increase staff retention. Progression criteria to a full trial are outlined at the end of the methods section.

Lay abstract: Aims. We aim to compare two talking therapies for women with depression during pregnancy. Background. One in eight women suffer from depression during pregnancy. Currently cognitive behavioural therapy (CBT) is the only talking treatment widely available in the NHS. This treatment involves identifying and changing unhelpful negative thoughts and behaviours to improve mood. Mothers in our PPI groups have asked for greater treatment choice. Interpersonal counselling (IPC) has been developed recently. It is also a brief one-to-one therapy. It addresses relationship problems, changes in role and previous losses (eg miscarriage) and we think has important advantages over CBT because it focuses on issues relevant to women during pregnancy. We believe women may be more likely to complete IPC and it may therefore work better than CBT. Methods. We will conduct a small study of 60 women to see whether a larger trial is possible. We will identify women with depression through midwife clinics and scanning appointments. Those willing to take part will be chosen at random to have either six sessions of IPC or of CBT. In every other way these women will receive usual care. Anyone thought to have severe depression will be referred for more intensive treatment. After 12-weeks we will measure women s mood, well-being, relationship satisfaction and use of health care. We will interview women, their partners and staff providing treatments in order to understand whether IPC is an acceptable approach and whether any changes should be introduced before applying to undertake a full-scale study. PPI. We have involved several groups of patients with depression during pregnancy in our study design. We have a patient advisory group who will continue to meet with us during the study. Dissemination. We will share our findings through public engagement events, academic papers and reports to organisations within the NHS.

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