Title: 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)
Funder: Department of Health and Social Care

Abstract: 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. PROJECT TIMETABLE: -4-0 months: Preparation, ethics and other approvals 1-4 months - Recruitment and training of staff and site initiation visits. 5-18 months: Internal pilot. 5-42 months: Recruitment of participants, internal pilot, baseline and follow up assessments, completion of intervention 43-48 months: Analysis, write-up and dissemination 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.

Lay abstract: The rates of postnatal depression (PND) in British South Asian women are higher than the general population. Postnatal depression is known to cause disability and suffering in women and negative consequences for their infants and their family with huge costs to society. Due to linguistic and cultural barriers, British South Asian women do not access health care services. This has been highlighted as a major contributor to inequitable healthcare across the UK populations. Mothers from South-Asian backgrounds (Bangladesh, Pakistan and India) make up for very large number of births in the UK and particularly in centres participating in this study. There is a growing concern about ethnic disparities in the provision and access to postnatal depression services which is an identified priority in both England and Scotland. The research team has worked closely with British South Asian women both in the research and clinical settings for a number of years and have extensive experience of how to recruit participants, deliver psychological interventions, and measure culturally appropriate outcomes. As part of this background work, members of the team have developed a culturally adapted postnatal depression group psychological intervention called the Positive Health Programme - PHP. We have previously tested this in smaller studies and the approach shows promise as an intervention for postnatal depression. It seems to lead to improved mood, and successfully engages and supports women from a South Asian background. We have also learned how best to deliver the content to this target group of depressed mothers. The current study involves 5 centres. The addition of extra centres around the UK will allow us to recruit the number of participants needed for us to robustly answer the question of whether the group psychological intervention is effective and value for money. It will also mean that we are including the range of local British South Asian communities to reflect communities in both England and Scotland. We aim to recruit sufficient number of depressed mothers into the study to allow us to determine whether the PHP approach is effective in terms of helping women recover from depression. We will also look at important extra areas such as the impact on anxiety, ability to live life confidently, and try to understand what factors affect how the group works and helps people. We are alert to the fact that working with British South Asian communities can be challenging as there are reports of poorer engagement with health services compared to the wider UK community, so we will also have detailed discussions with the participants as well as local service workers, leads and commissioners. We will use an established approach in order to understand what factors block and facilitate successful delivery of the programme. At the end of the research we hope to have answered how clinically effective, cost effective and acceptable the programme is, and also summarise our findings in a delivery manual that can be freely used by other centres who might wish to deliver the same package in their centres. The cost-effectiveness issue is important, as recent reviews of previous research in this field have failed to answer the important question of whether similar approaches are value for money. Our study aims to address this lack of information by including a well-designed cost-effectiveness component.

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