Multi Centre RCT of a group psychOlogical intervention for poStnatal depression in britisH mothers of south asiaN origIn - ROSHNI-2 (The word Roshni means ‘light’ in Urdu/Hindi)

Design: A multicentre Randomised Control Trial with a partially nested design to compare Treatment as Usual (TAU) plus the Positive Health Programme (PHP) with TAU in British South Asian (BSA) women with postnatal depression. There is a built in 18 months internal pilot phase with clear stop/go criteria to prove viability to proceed to a full trial across all the study sites. Setting: Participants will be recruited from general practices and children centres in areas of high BSA density in North West, East Midlands, Yorkshire, Glasgow and London. Target Population: Self-ascribed British South Asian women meeting DSM V depression criteria, aged 16 years or above, and having an infant up to 12 months of age. Health Technologies Being Assessed: A culturally adapted group intervention, based on the principles of Cognitive Behavioural Therapy (CBT). The manual-assisted intervention has been designed to be delivered by non-specialist mental health professionals. The intervention has 12 sessions, approximately 60-90 minutes each, and its feasibility has previously been established. Measurement of Costs and Outcomes: The primary outcome is recovery from depression (Hamilton Rating Scale for Depression (HRSD) score less than 7) at 4 months (end of intervention). The analysis of the primary outcome and the long-term follow-up (at 12 months) will use a logistic random effects model to estimate the odds-ratio of caseness between treatment, adjusting for severity of depression, parity, and education at baseline. Cost data will be collected using an Economic Patient Questionnaire (EPQ). Economic analysis will estimate the costs of health and social care and quality adjusted life years (QALYs) from a societal perspective. Qualitative methods will be employed to explore patient and professional experiences. Sample Size: With 40 groups of size 9 and 360 control subjects the trial will have 90% power to detect a clinically important difference between a 55% recovery rate in the intervention and a 40% recovery rate in the control assuming an ICC for group treatment of 0.05, a 75% follow-up and a 5% significance level. We believe that an ICC for group treatment of this magnitude is plausible, but the trial is robust to larger values. If the ICC for group treatment is as large as 0.1, the power is still greater than 86% We will use an established approach in order to understand what factors block and facilitate successful delivery of the programme. EXPERTISE: We have a strong multidisciplinary team. NH, NC, AR, CW, NA, KB, KL. NSi, AB, FN, CB, DW, PB, CR, IB, JKa CCG, RR, JM, WW, TB, RM with experience of conducing trials of CBT in primary care and recruiting BSA participants. A strong health economics team LD and SM. The trial statisticians have expertise in trials of psychological interventions (CR, BT). NS and JK are experts by experience. Add on study - The existing cohort of 4,319 participants on the ROSHNI-2 trial in the five study centres (Northwest, Yorkshire, East Midlands and London) have been invited to participate in the add-on study. In addition, the study is inviting BSA mothers beyond the ROSHNI-2 participants via existing contacts and through social media campaigns, GP's and BSA community organisations. Methodology - For data collection, we are using a mixed-method approach including online survey and one-to-one interview and focus group discussion. The COVID-19 impact survey will be completed by the participants via an online link (Qualtrics - available in Urdu, Punjabi, Gujarati, Hindi, Bangla, Tamil) or over the telephone and will include questions related to mental health, isolation, education, relationships, child development, views on the vaccination, and wider impacts. In addition, the study will also explore the nature and intensity of breastfeeding problems encountered, help seeking behaviour, and sources of support for the mothers during the pandemic.The screening tool for Interpersonal Violence (IPV) -HITS (Hurt, Insult, Threaten, and Scream will be integrated within the survey and participants who score on this will be approached to complete further assessments specific to IPV. Similarly, during the one-to-one interviews and focus group discussion, questions will explore IPV, and anyone indicating experience of IPV will answer further questions to understand their experiences in more detail. The qualitative interviews will be conducted with participants and key stakeholders including mid-wives, health visitors, general practitioners, and third sector organizations to understand from their perspectives the experiences of BSA women related to the pandemic and in accessing support services and the wider impact of the pandemic, including what future programs on IPV should include. We will be interviewing a total of 70 participants (35 BSA women and 35 health care professionals and representatives from third sector organisations). Research significance: This study will identify difficulties, barriers, and consequences of COVID-19 in BSA women and suggest key recommendations to inform the NHS England and NHS Confederation. The study will also inform the design of future IPV-related mental health interventions and inform the training roles of health professionals and key stakeholders working with BSA survivors of IPV.