TY - JOUR
T1 - Effectiveness of a Brief Psychological Intervention Delivered by Nurse for Depression in Pregnancy
T2 - Study Protocol for a Multicentric Randomized Controlled Trial from India
AU - Raghuveer, Pracheth
AU - Ransing, Ramdas
AU - Kukreti, Prerna
AU - Mahadevaiah, Mahesh
AU - Elbahaey, Wafaa Abdelhakim
AU - Iyengar, Satish
AU - Pemde, Harish
AU - Deshpande, Smita N.
N1 - Funding Information:
This work is part of the BIND-P project (CTRI/2018/07/014836) under the Capacity Building group of NCD-ICMR. The work was supported by the ICMR under Capacity Building Projects for NMHP. We thank Dr Soumya Swaminathan, then Secretary, Department of Health Research (DHR), Dr Balram Bhargav, current Secretary DHR, Prof. V. L. Nimgaonkar, Dr Ravinder Singh, and Dr Harpreet Singh. We thank the faculty of “Cross-Fertilized Research Training for New Investigators in India and Egypt” (D43 TW009114, HMSC File No. Indo-Foreign/35/M/2012-NCD-1, funded by Fogarty International Centre, NIH). We are also thankful to the National Coordinating Unit (NCU) of ICMR for NMHP Projects for their constant support and guidance. We thank the DMU of ICMR for designing the database. The content of this manuscript is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Health (NIH) or ICMR. NIH and ICMR had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Funding Information:
This work is part of the BIND-P project (CTRI/2018/07/014836) under the Capacity Building group of NCD-ICMR. The work was supported by the ICMR under Capacity Building Projects for NMHP. We thank Dr Soumya Swaminathan, then Secretary, Department of Health Research (DHR), Dr Balram Bhargav, current Secretary DHR, Prof. V. L. Nimgaonkar, Dr Ravinder Singh, and Dr Harpreet Singh. We thank the faculty of ?Cross-Fertilized Research Training for New Investigators in India and Egypt? (D43 TW009114, HMSC File No. Indo-Foreign/35/M/2012-NCD-1, funded by Fogarty International Centre, NIH). We are also thankful to the National Coordinating Unit (NCU) of ICMR for NMHP Projects for their constant support and guidance. We thank the DMU of ICMR for designing the database. The content of this manuscript is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Health (NIH) or ICMR. NIH and ICMR had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Publisher Copyright:
© 2020 Indian Psychiatric Society - South Zonal Branch.
PY - 2020/12
Y1 - 2020/12
N2 - Background: Perinatal depression (PD) has important implications for maternal and infant well-being but largely goes undetected. There is a need to develop low-intensity psychosocial interventions applicable to obstetric health care facilities. Objective: To assess the effectiveness of a brief psychological intervention for mild to moderate PD delivered by a nurse as compared to treatment-as-usual (TAU). Methods: This study is a randomized, open-label, parallel-group, multicentric trial being conducted in four sites of India. A total of 816 pregnant women with mild to moderately severe depression (Patient Health Questionaire-9 score of 5–19) are being assessed for the effectiveness of the intervention. Participants are randomly allocated to two groups of trial intervention (psychological intervention given by nurse) and TAU. The primary outcome is to compare the proportion of women reporting improvement across both groups. Participants are serially followed-up in each trimester and at 6, 10, 14 weeks, and 6 months postpartum. Secondary outcomes include pregnancy outcomes, feeding practices, physical growth, and immunization status of the infants. Conclusion: It is a prospective pregnancy birth cohort with a robust design and long-term follow-up. This is one of the largest studies utilizing non-specialist health workers for the screening and management of PD. This study also holds promise to cast light on the course and outcome of depression during pregnancy in different parts of India. It is envisaged to help in developing a sound screening and referral-based protocol for obstetric settings.
AB - Background: Perinatal depression (PD) has important implications for maternal and infant well-being but largely goes undetected. There is a need to develop low-intensity psychosocial interventions applicable to obstetric health care facilities. Objective: To assess the effectiveness of a brief psychological intervention for mild to moderate PD delivered by a nurse as compared to treatment-as-usual (TAU). Methods: This study is a randomized, open-label, parallel-group, multicentric trial being conducted in four sites of India. A total of 816 pregnant women with mild to moderately severe depression (Patient Health Questionaire-9 score of 5–19) are being assessed for the effectiveness of the intervention. Participants are randomly allocated to two groups of trial intervention (psychological intervention given by nurse) and TAU. The primary outcome is to compare the proportion of women reporting improvement across both groups. Participants are serially followed-up in each trimester and at 6, 10, 14 weeks, and 6 months postpartum. Secondary outcomes include pregnancy outcomes, feeding practices, physical growth, and immunization status of the infants. Conclusion: It is a prospective pregnancy birth cohort with a robust design and long-term follow-up. This is one of the largest studies utilizing non-specialist health workers for the screening and management of PD. This study also holds promise to cast light on the course and outcome of depression during pregnancy in different parts of India. It is envisaged to help in developing a sound screening and referral-based protocol for obstetric settings.
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U2 - 10.1177/0253717620971559
DO - 10.1177/0253717620971559
M3 - Article
AN - SCOPUS:85105701088
SN - 0253-7176
VL - 42
SP - S23-S30
JO - Indian Journal of Psychological Medicine
JF - Indian Journal of Psychological Medicine
IS - 6_suppl
ER -