Comparing low intensity talking therapies for antenatal depression: a feasibility trial

INTERVENTION: 12 low‐intensity practitioners working in NHS psychological treatment services will be randomised 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 (EPDS score of 10 or more and 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 20 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 online or by telephone 12 weeks following randomisation. These will include: the Edinburgh Depression Scale (questionnaire), relationship measures (Revised Dyadic Adjustment Scale and Maternal Antenatal Attachment Scale questionnaires), health economic measures (EQ‐5D‐5L and ReQol10 questionnaires). 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 from practitioner records. In‐depth interviews will be conducted with women who have completed IPC (10‐12 women) or CBT (5‐6 women) and their partners focusing on the acceptability and perceived effectiveness of the talking therapy. Interviews will also be conducted with study decliners, where possible, to understand ways in which participation might be supported. Practitioners in the IPC arm, their supervisors and midwives, will be interviewed at the end of the intervention to focus on the acceptability, strengths and weaknesses of the intervention and recruitment process. CONDITION: Antenatal depression ; Mental and Behavioural Disorders PRIMARY OUTCOME: ; 1. Recruitment rate, measured using trial documentation after 9 months of recruitment (October 2019); 2. Number of women who receive complete IPC treatment as judged by the practitioner from practitioner records at the end of the trial; 3. Number of women who complete outcome data, measured 4 months after recruitment for each participant; 4. Acceptability of IPC and trial design assessed using in‐depth interviews at 4‐6 months after recruitment; 5. Supervisor’s rating of practitioner’s adherence to the IPC model at the end of the trial; SECONDARY OUTCOME: ; Measured at baseline and 12 weeks after recruitment for each participant using validated tools completed on paper or online:; 1. Depression symptoms are measured using Edinburgh Depression Scale (EPDS); 2. Partner satisfaction and relationships are measured using Revised Dyadic Adjustment Scales (RDAS); 3. Maternal attachment to her unborn baby is measured using Maternal Antenatal Attachment Scale (MAAS); 4. Health‐based wellbeing is measured using EQ‐5D‐5L; 5. Wellbeing, particularly for mental health problems, is measured using ReQol‐10; INCLUSION CRITERIA: 1. Women who are pregnant 2. Mild or moderate depression with or without co‐morbid anxiety 3, Both primiparous and multiparous women 4. Between 10 and 20 weeks of pregnancy 5. Edinburgh Depression Scale (EPDS) score above 10 6. Mild or moderate depression according to Clinical Interview Schedule Revised (CIS‐R) (Lewis et al 1992) 7. Whether or not they are taking an antidepressant