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Multi-centre randomised controlled trial for postnatal depression in British South Asian women - ROSHNI-2

Multi Centre RCT of a group psychOlogical intervention for poStnatal depression in britisH mothers of south asiaN origIn - ROSHNI-2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10697380
Enrollment
720
Registered
2017-01-26
Start date
2017-02-08
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postnatal depression, maternal mental health, interpersonal violence Mental and Behavioural Disorders Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified

Interventions

Consenting, eligible women will be randomized via an independent remote randomisation service based at the King's College Clinical trials unit (CTU). After each block of 18 women have been recruited i

Sponsors

Lancashire Care NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Self-ascribed British women of South Asian origin as defined by Office of National Statistics (ONS, 2011) 2. Over the age of 16 years and living with their infants up to the age of 12 months (1-Year) 3. Meet the criteria for DSM-V depression

Exclusion criteria

Exclusion criteria: 1. Women with diagnosed learning disability that will impact on capacity to consent 2. Postpartum psychosis 3. Any other diagnosed psychosis 4. Actively suicidal (previous history of self-harm or suicide attempt).

Design outcomes

Primary

MeasureTime frame
Recovery from postnatal depression is measured using the Hamilton Depression Rating Scale (HDRS) at 4 months (end of intervention)

Secondary

MeasureTime frame
1. Treatment response is measured using the Hamilton Depression Rating Scale (HDRS) at baseline, 4 and 12 months 2. Cost data will be collected using an Economic Patient Questionnaire at baseline, 4 and 12 months

Countries

England, United Kingdom

Contacts

Public ContactFarah Lunat
farah.lunat@lscft.nhs.uk+44 (0)1772 773498

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 10, 2026