Multicentre randomised controlled trial of a group psychological intervention for postnatal depression in British mothers of South Asian origin (ROSHNI-2): Study protocol

Nusrat Husain; Karina Lovell; Carolyn A. Chew-Graham; Farah Lunat; Rebecca McPhillips; Najia Atif; Saadia Aseem; Jasmin Begum; Penny Bee; Kamaldeep Bhui; Peter Bower; Traolach Brugha; Nafeesa Bhatti; Nasim Chaudhry; Linda Davies; Nadeem Gire; Anharul Islam; Joe Kai; Jill Morrison; Naeem Mohmed; Jyothi Neelam; Atif Rahman; Shanaya Rathod; Najma Siddiqi; Sadia Shah; Tinevimbo Shiri; Waquas Waheed; Ilyas Mirza; Chris Williams; Nosheen Zaidi; Richard Emsley; Richard Morriss

doi:10.1192/bjo.2021.1032

Multicentre randomised controlled trial of a group psychological intervention for postnatal depression in British mothers of South Asian origin (ROSHNI-2): Study protocol

Nusrat Husain^*, Karina Lovell, Carolyn A. Chew-Graham, Farah Lunat, Rebecca McPhillips, Najia Atif, Saadia Aseem, Jasmin Begum, Penny Bee, Kamaldeep Bhui, Peter Bower, Traolach Brugha, Nafeesa Bhatti, Nasim Chaudhry, Linda Davies, Nadeem Gire, Anharul Islam, Joe Kai, Jill Morrison, Naeem MohmedJyothi Neelam, Atif Rahman, Shanaya Rathod, Najma Siddiqi, Sadia Shah, Tinevimbo Shiri, Waquas Waheed, Ilyas Mirza, Chris Williams, Nosheen Zaidi, Richard Emsley, Richard Morriss

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

2 Citations (Scopus)

Abstract

Background In the UK, postnatal depression is more common in British South Asian women than White Caucasion women. Cognitive-behavioural therapy (CBT) is recommended as a first-line treatment, but there is little evidence for the adaptation of CBT for postnatal depression to ensure its applicability to different ethnic groups. Aims To evaluate the clinical and cost-effectiveness of a CBT-based positive health programme group intervention in British South Asian women with postnatal depression. Method We have designed a multicentre, two-arm, partially nested, randomised controlled trial with 4- and 12-month follow-up, comparing a 12-session group CBT-based intervention (positive health programme) plus treatment as usual with treatment as usual alone, for British South Asian women with postnatal depression. Participants will be recruited from primary care and appropriate community venues in areas of high South Asian density across the UK. It has been estimated that randomising 720 participants (360 into each group) will be sufficient to detect a clinically important difference between a 55% recovery rate in the intervention group and a 40% recovery rate in the treatment-as-usual group. An economic analysis will estimate the cost-effectiveness of the positive health programme. A qualitative process evaluation will explore barriers and enablers to study participation and examine the acceptability and impact of the programme from the perspective of British South Asian women and other key stakeholders.

Original language	English
Article number	A404
Journal	BJPsych Open
Volume	8
Issue number	1
DOIs	https://doi.org/10.1192/bjo.2021.1032
Publication status	Published - 1 Jan 2022

Keywords

cognitive-behavioural therapies
depressive disorders
Perinatal psychiatry
psychosocial interventions
randomised controlled trial

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1192/bjo.2021.1032

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Husain, N., Lovell, K., Chew-Graham, C. A., Lunat, F., McPhillips, R., Atif, N., Aseem, S., Begum, J., Bee, P., Bhui, K., Bower, P., Brugha, T., Bhatti, N., Chaudhry, N., Davies, L., Gire, N., Islam, A., Kai, J., Morrison, J., ... Morriss, R. (2022). Multicentre randomised controlled trial of a group psychological intervention for postnatal depression in British mothers of South Asian origin (ROSHNI-2): Study protocol. BJPsych Open, 8(1), Article A404. https://doi.org/10.1192/bjo.2021.1032

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title = "Multicentre randomised controlled trial of a group psychological intervention for postnatal depression in British mothers of South Asian origin (ROSHNI-2): Study protocol",

abstract = "Background In the UK, postnatal depression is more common in British South Asian women than White Caucasion women. Cognitive-behavioural therapy (CBT) is recommended as a first-line treatment, but there is little evidence for the adaptation of CBT for postnatal depression to ensure its applicability to different ethnic groups. Aims To evaluate the clinical and cost-effectiveness of a CBT-based positive health programme group intervention in British South Asian women with postnatal depression. Method We have designed a multicentre, two-arm, partially nested, randomised controlled trial with 4- and 12-month follow-up, comparing a 12-session group CBT-based intervention (positive health programme) plus treatment as usual with treatment as usual alone, for British South Asian women with postnatal depression. Participants will be recruited from primary care and appropriate community venues in areas of high South Asian density across the UK. It has been estimated that randomising 720 participants (360 into each group) will be sufficient to detect a clinically important difference between a 55% recovery rate in the intervention group and a 40% recovery rate in the treatment-as-usual group. An economic analysis will estimate the cost-effectiveness of the positive health programme. A qualitative process evaluation will explore barriers and enablers to study participation and examine the acceptability and impact of the programme from the perspective of British South Asian women and other key stakeholders. ",

keywords = "cognitive-behavioural therapies, depressive disorders, Perinatal psychiatry, psychosocial interventions, randomised controlled trial",

author = "Nusrat Husain and Karina Lovell and Chew-Graham, {Carolyn A.} and Farah Lunat and Rebecca McPhillips and Najia Atif and Saadia Aseem and Jasmin Begum and Penny Bee and Kamaldeep Bhui and Peter Bower and Traolach Brugha and Nafeesa Bhatti and Nasim Chaudhry and Linda Davies and Nadeem Gire and Anharul Islam and Joe Kai and Jill Morrison and Naeem Mohmed and Jyothi Neelam and Atif Rahman and Shanaya Rathod and Najma Siddiqi and Sadia Shah and Tinevimbo Shiri and Waquas Waheed and Ilyas Mirza and Chris Williams and Nosheen Zaidi and Richard Emsley and Richard Morriss",

note = "Funding Information: This project has been funded by the National Institute of Health Research (NIHR), Health Technology Assessment (HTA) programme (project number 14/68/08). The views and opinions expressed are those of the authors and do not necessarily reflect those of the NIHR HTA programme, National Health Service or the Department of Health. Funding Information: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare no support from any organisation for the submitted work. N.H. is Chair of the Board of Trustees at Manchester Global Foundation; a charitable incorporated organization. He was former trustee at Lancashire MIND, Abaseen Foundation and Pakistan Institute of Living and Learning. N.H. is an NIHR Senior Investigator. S.R. has received grants from Janssen, Otsuka and commercial companies outside the submitted work. P.Bower. reports other grants from NIHR during the conduct of the study. N.S. was a former patient in the exploratory phase of this trial. K.B., a member of the British Journal of Psychiatry Editorial Board, but did not take part in the review or decision-making process of this paper. All authors declare no other relationships or activities that could appear to have influenced the submitted work. Publisher Copyright: Copyright {\textcopyright} The Author(s), 2021. Published by Cambridge University Press on behalf of the Royal College of Psychiatrists.",

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doi = "10.1192/bjo.2021.1032",

language = "English",

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Husain, N, Lovell, K, Chew-Graham, CA, Lunat, F, McPhillips, R, Atif, N, Aseem, S, Begum, J, Bee, P, Bhui, K, Bower, P, Brugha, T, Bhatti, N, Chaudhry, N, Davies, L, Gire, N, Islam, A, Kai, J, Morrison, J, Mohmed, N, Neelam, J, Rahman, A, Rathod, S, Siddiqi, N, Shah, S, Shiri, T, Waheed, W, Mirza, I, Williams, C, Zaidi, N, Emsley, R & Morriss, R 2022, 'Multicentre randomised controlled trial of a group psychological intervention for postnatal depression in British mothers of South Asian origin (ROSHNI-2): Study protocol', BJPsych Open, vol. 8, no. 1, A404. https://doi.org/10.1192/bjo.2021.1032

TY - JOUR

T1 - Multicentre randomised controlled trial of a group psychological intervention for postnatal depression in British mothers of South Asian origin (ROSHNI-2)

T2 - Study protocol

AU - Husain, Nusrat

AU - Lovell, Karina

AU - Chew-Graham, Carolyn A.

AU - Lunat, Farah

AU - McPhillips, Rebecca

AU - Atif, Najia

AU - Aseem, Saadia

AU - Begum, Jasmin

AU - Bee, Penny

AU - Bhui, Kamaldeep

AU - Bower, Peter

AU - Brugha, Traolach

AU - Bhatti, Nafeesa

AU - Chaudhry, Nasim

AU - Davies, Linda

AU - Gire, Nadeem

AU - Islam, Anharul

AU - Kai, Joe

AU - Morrison, Jill

AU - Mohmed, Naeem

AU - Neelam, Jyothi

AU - Rahman, Atif

AU - Rathod, Shanaya

AU - Siddiqi, Najma

AU - Shah, Sadia

AU - Shiri, Tinevimbo

AU - Waheed, Waquas

AU - Mirza, Ilyas

AU - Williams, Chris

AU - Zaidi, Nosheen

AU - Emsley, Richard

AU - Morriss, Richard

N1 - Funding Information: This project has been funded by the National Institute of Health Research (NIHR), Health Technology Assessment (HTA) programme (project number 14/68/08). The views and opinions expressed are those of the authors and do not necessarily reflect those of the NIHR HTA programme, National Health Service or the Department of Health. Funding Information: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare no support from any organisation for the submitted work. N.H. is Chair of the Board of Trustees at Manchester Global Foundation; a charitable incorporated organization. He was former trustee at Lancashire MIND, Abaseen Foundation and Pakistan Institute of Living and Learning. N.H. is an NIHR Senior Investigator. S.R. has received grants from Janssen, Otsuka and commercial companies outside the submitted work. P.Bower. reports other grants from NIHR during the conduct of the study. N.S. was a former patient in the exploratory phase of this trial. K.B., a member of the British Journal of Psychiatry Editorial Board, but did not take part in the review or decision-making process of this paper. All authors declare no other relationships or activities that could appear to have influenced the submitted work. Publisher Copyright: Copyright © The Author(s), 2021. Published by Cambridge University Press on behalf of the Royal College of Psychiatrists.

PY - 2022/1/1

Y1 - 2022/1/1

N2 - Background In the UK, postnatal depression is more common in British South Asian women than White Caucasion women. Cognitive-behavioural therapy (CBT) is recommended as a first-line treatment, but there is little evidence for the adaptation of CBT for postnatal depression to ensure its applicability to different ethnic groups. Aims To evaluate the clinical and cost-effectiveness of a CBT-based positive health programme group intervention in British South Asian women with postnatal depression. Method We have designed a multicentre, two-arm, partially nested, randomised controlled trial with 4- and 12-month follow-up, comparing a 12-session group CBT-based intervention (positive health programme) plus treatment as usual with treatment as usual alone, for British South Asian women with postnatal depression. Participants will be recruited from primary care and appropriate community venues in areas of high South Asian density across the UK. It has been estimated that randomising 720 participants (360 into each group) will be sufficient to detect a clinically important difference between a 55% recovery rate in the intervention group and a 40% recovery rate in the treatment-as-usual group. An economic analysis will estimate the cost-effectiveness of the positive health programme. A qualitative process evaluation will explore barriers and enablers to study participation and examine the acceptability and impact of the programme from the perspective of British South Asian women and other key stakeholders.

AB - Background In the UK, postnatal depression is more common in British South Asian women than White Caucasion women. Cognitive-behavioural therapy (CBT) is recommended as a first-line treatment, but there is little evidence for the adaptation of CBT for postnatal depression to ensure its applicability to different ethnic groups. Aims To evaluate the clinical and cost-effectiveness of a CBT-based positive health programme group intervention in British South Asian women with postnatal depression. Method We have designed a multicentre, two-arm, partially nested, randomised controlled trial with 4- and 12-month follow-up, comparing a 12-session group CBT-based intervention (positive health programme) plus treatment as usual with treatment as usual alone, for British South Asian women with postnatal depression. Participants will be recruited from primary care and appropriate community venues in areas of high South Asian density across the UK. It has been estimated that randomising 720 participants (360 into each group) will be sufficient to detect a clinically important difference between a 55% recovery rate in the intervention group and a 40% recovery rate in the treatment-as-usual group. An economic analysis will estimate the cost-effectiveness of the positive health programme. A qualitative process evaluation will explore barriers and enablers to study participation and examine the acceptability and impact of the programme from the perspective of British South Asian women and other key stakeholders.

KW - cognitive-behavioural therapies

KW - depressive disorders

KW - Perinatal psychiatry

KW - psychosocial interventions

KW - randomised controlled trial

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U2 - 10.1192/bjo.2021.1032

DO - 10.1192/bjo.2021.1032

M3 - Article

AN - SCOPUS:85120873921

SN - 2056-4724

VL - 8

JO - BJPsych Open

JF - BJPsych Open

IS - 1

M1 - A404

ER -

Multicentre randomised controlled trial of a group psychological intervention for postnatal depression in British mothers of South Asian origin (ROSHNI-2): Study protocol

Abstract

Keywords

UN SDGs

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