TY - JOUR

T1 - Implementing and evaluating group interpersonal therapy for postnatal depression in Lebanon and Kenya-individually randomised superiority trial

AU - Fonagy, Peter

AU - Chammay, Rabih El

AU - Ngunu, Carol

AU - Kumar, Manasi

AU - Verdeli, Lena

AU - Allison, Elizabeth

AU - Anani, Ghida

AU - Fearon, Pasco

AU - Fouad, Fouad

AU - Hoare, Zoe

AU - Koyio, Lucina

AU - Moore, Henrietta

AU - Nyandigisi, Andrew

AU - Pilling, Stephen

AU - Sender, Hannah

AU - Skordis, Jolene

AU - Evans, Rachel

AU - Jaoude, Gerard Joseph Abou

AU - Madeghe, Beatrice

AU - Maradian, Sandra Pardi Arsen

AU - O'Donnell, Ciara

AU - Simes, Elizabeth

AU - Truscott, Alexandra

AU - Wambua, Grace Nduku

AU - Yator, Obadia

N1 - © 2024. The Author(s).

PY - 2024/3/26

Y1 - 2024/3/26

N2 - BACKGROUND: Depression ranks as the foremost mental health concern among childbearing women. Within low- and middle-income countries (LMICs), between 20 and 25% of women encounter depression during pregnancy or soon after delivery. This condition impacts not only the mothers but also their offspring. Offspring of women suffering from postnatal depression (PND) exhibit suboptimal cognitive development and increased emotional and behavioural issues throughout their growth. This scenario becomes more pronounced in LMICs, where numerous adversities further jeopardise children's developmental progress. Despite antenatal services providing a pivotal platform to address women's mental health needs, PND treatment remains inaccessible in many LMICs. The World Health Organization advocates interpersonal psychotherapy (IPT) for treating depression. While research from high-income countries has established the efficacy of IPT and group-IPT (g-IPT) for PND, its effectiveness within the LMIC context and its potential benefits for child development remain uncharted. This study seeks to gauge the potency of g-IPT for women with PND in two LMICs.METHODS: This multi-site randomised controlled trial is a continuation of two preceding phases-conceptual mapping and a feasibility study executed in Lebanon and Kenya. Insights gleaned from these phases underpin this comprehensive RCT, which contrasts the efficacy and cost-effectiveness of high-quality standard care (HQ-SC) augmented with g-IPT against HQ-SC in isolation. The trial, characterised as an individually randomised superiority assessment, targets women with postnatal depression in Beirut, Lebanon, and Nairobi, Kenya. It aims to determine if culturally tailored g-IPT, administered within community settings in both countries, outperforms HQ-SC in influencing child developmental outcomes, maternal depression, and the quality of the mother-child bond.DISCUSSION: The SUMMIT trial, designed with pragmatism, possesses the magnitude to evaluate g-IPT within two LMIC frameworks. It seeks to enlighten policymakers, service commissioners, professionals, and users about g-IPT's potential to alleviate maternal PND and bolster child developmental outcomes in LMICs. Additionally, the trial will generate valuable data on the clinical and economic merits of high-quality standard care.TRIAL REGISTRATION: ISRCTN, ISRCTN15154316. Registered on 27 September 2023, https://doi.org/10.1186/ISRCTN15154316.

AB - BACKGROUND: Depression ranks as the foremost mental health concern among childbearing women. Within low- and middle-income countries (LMICs), between 20 and 25% of women encounter depression during pregnancy or soon after delivery. This condition impacts not only the mothers but also their offspring. Offspring of women suffering from postnatal depression (PND) exhibit suboptimal cognitive development and increased emotional and behavioural issues throughout their growth. This scenario becomes more pronounced in LMICs, where numerous adversities further jeopardise children's developmental progress. Despite antenatal services providing a pivotal platform to address women's mental health needs, PND treatment remains inaccessible in many LMICs. The World Health Organization advocates interpersonal psychotherapy (IPT) for treating depression. While research from high-income countries has established the efficacy of IPT and group-IPT (g-IPT) for PND, its effectiveness within the LMIC context and its potential benefits for child development remain uncharted. This study seeks to gauge the potency of g-IPT for women with PND in two LMICs.METHODS: This multi-site randomised controlled trial is a continuation of two preceding phases-conceptual mapping and a feasibility study executed in Lebanon and Kenya. Insights gleaned from these phases underpin this comprehensive RCT, which contrasts the efficacy and cost-effectiveness of high-quality standard care (HQ-SC) augmented with g-IPT against HQ-SC in isolation. The trial, characterised as an individually randomised superiority assessment, targets women with postnatal depression in Beirut, Lebanon, and Nairobi, Kenya. It aims to determine if culturally tailored g-IPT, administered within community settings in both countries, outperforms HQ-SC in influencing child developmental outcomes, maternal depression, and the quality of the mother-child bond.DISCUSSION: The SUMMIT trial, designed with pragmatism, possesses the magnitude to evaluate g-IPT within two LMIC frameworks. It seeks to enlighten policymakers, service commissioners, professionals, and users about g-IPT's potential to alleviate maternal PND and bolster child developmental outcomes in LMICs. Additionally, the trial will generate valuable data on the clinical and economic merits of high-quality standard care.TRIAL REGISTRATION: ISRCTN, ISRCTN15154316. Registered on 27 September 2023, https://doi.org/10.1186/ISRCTN15154316.

KW - Female

KW - Humans

KW - Depression, Postpartum/therapy

KW - Kenya

KW - Lebanon

KW - Psychotherapy, Group

KW - Women's Health

U2 - 10.1186/s13063-024-08039-3

DO - 10.1186/s13063-024-08039-3

M3 - Article

C2 - 38532432

VL - 25

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 217

ER -