A group psychological intervention for postnatal depression in British mothers of South Asian origin - the ROSHNI-2 RCT.

Background: Postnatal depression is more common in British South Asian women than white women in the United Kingdom. Despite empirical evidence suggesting the effectiveness of cognitive-behavioural therapy as a first line of treatment, little evidence is available regarding its applicability to different minority ethnic groups.

Objectives: Determining the clinical and cost-effectiveness of a culturally adapted group psychological intervention (Positive Health Programme) in primary care for British South Asian women with postnatal depression compared with treatment as usual.

Setting: General practices and children's centres in the North West, East Midlands, Yorkshire, Glasgow and London.

Participants: British South Asian women meeting the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) depression criteria, aged 16 years or above, with infants up to 12 months.

Design: A multicentre randomised controlled trial with an internal pilot and partially nested design to compare treatment as usual plus the Positive Health Programme with treatment as usual in British South Asian women with postnatal depression, with a qualitative study to examine the acceptability and feasibility of the intervention.

Intervention: The Positive Health Programme, a culturally adapted group intervention based on the principles of cognitive-behavioural therapy delivered by facilitators over 12 sessions.

Outcomes measures: The primary outcome was recovery from depression (Hamilton Depression Rating Scale ≤ 7) at end of intervention (approximately 4-6 months). Analysis of the primary outcome and the long-term follow-up (at 12 months) used a logistic random-effects model to estimate the odds ratio of caseness between treatments, adjusting for centre, severity of depression and education at baseline. Cost data were collected using an Economic Patient Questionnaire.

Results: Seven hundred and thirty-two participants across four study centres were randomised by the Manchester Clinical Trials Unit. At 4 months, almost half of patients in the treatment (Positive Health Programme) group were recovered (138 or 49%), whereas 105 (37%) were recovered in the control (treatment as usual) group. By 12 months, the control (treatment as usual) and treatment (Positive Health Programme) group had over 50% recovery at 140 (54%) and 141 (54%), respectively. For the primary outcome, recovery from postnatal depression at end of intervention, we found a significant effect such that the odds of achieving recovery in the treatment group were almost twice as high compared to the treatment as usual group (odds ratio 1.97, 95% confidence interval 1.26 to 3.10). Between the two groups, there was no significant difference in the odds of recovery at 12 months (odds ratio 1.02, 95% confidence interval 0.62 to 1.66), highlighting a need for more intensive therapies and/or longer-term care plans for this group of patients.

Qualitative results: The intervention was considered feasible and acceptable from the perspectives of Positive Health Programme participants, facilitators, and general practitioners. The findings suggest improved emotional and social support and an enhanced sense of well-being.

Economic evaluation: Positive Health Programme implementation was estimated to cost an average of £408 per participant. The intention-to-treat analysis shows that the Positive Health Programme intervention costs £22,198 per quality-adjusted life-year gain. Positive Health Programme was cost-effective on average but with a substantial uncertainty: the probability that Positive Health Programme was cost-effective was 44% (65%) at the willingness to pay £20,000 (£30,000) per quality-adjusted life-year. The Positive Health Programme was highly cost-effective for those who attended 5-8 sessions, costing £9040 per quality-adjusted life-year.

Limitations: The study sample limits generalisability with other ethnic minority groups, and the cost-effectiveness analysis did not explore recall bias.

Conclusions: The results of this study provide robust evidence that the culturally adapted psychological intervention for postnatal depression in South Asian women is effective at the primary end point and acceptable to women.

Future work: Further development of the Positive Health Programme intervention and evaluation, with longer-term outcome follow-ups and exploration of cost-effectiveness of remote delivery of the Positive Health Programme.

Study registration: Current Controlled Trials ISRCTN10697380.

Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/68/08) and is published in full in Health Technology Assessment; Vol. 29, No. 6. See the NIHR Funding and Awards website for further award information.