Ignite Creation Date:
2024-05-06 @ 2:52 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04442529
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2020-06-18
Brief Title:
Mothers and Babies Qatar MB-Q A Postpartum Depression Intervention
Sponsor:
Sidra Medicine
Organization:
Sidra Medicine
Study Overview
Official Title:
Qatar Mothers and Babies Examining the Feasibility Acceptability and Preliminary Outcomes Associated With Integrating a Postpartum Depression Intervention Into Perinatal Services for Women
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
Not yet recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MB
Brief Summary:
Qatar Mothers and Babies is a 4-year collaboration between Northwestern University Feinberg School of Medicine and Sidra Medicine in Doha Qatar that will generate and evaluate a cultural and contextual adaptation of the Mothers and Babies intervention for pregnant Arabic-speaking women in Qatar The study will examine the feasibility and acceptability of the adapted intervention as well as its effectiveness in improving mental health outcomes among pregnant women receiving prenatal care at Sidra Medicine in Doha Additionally given the high prevalence of diabetes among this study population the investigators are also interested in seeing if the Mothers and Babies interventions helps improve the management of this disease Funded by the Qatar National Research Funds National Priorities Research Program NPRP this project has the potential to guide future cultural adaptations of Mothers and Babies as well as other evidence-based interventions and the delivery of Mothers and Babies to Arab and Arab-American women
Detailed Description:
Postpartum depression and anxiety are the two most common perinatal mental health disorders mental health disorders occurring during pregnancy and the year after birth with prevalence rates higher among women living in Qatar than in most western countries The negative outcomes associated with postpartum depression and anxiety are profound and include poor birth outcomes poor parenting practices and compromised infant and young child development Although interventions exist to prevent postpartum depression and anxiety to date there have been no studies that have attempted to prevent postpartum depression or anxiety among Arabic speaking women in the Middle East including Qatar This project brings together a multidisciplinary team of researchers and clinicians from Sidra Medicine Qatar and Northwestern University Feinberg School of Medicine USA to conduct a first-of-its-kind study that examines the feasibility acceptability and outcomes associated with an evidence-based postpartum depression intervention-Mothers and Babies MB MB has been widely used in the USA and has been linguistically translated into Arabic and successfully delivered to Arab-American women In Phase One of this project the investigators will culturally and contextually adapt Mothers and Babies to ensure its suitability for use with women residing in Qatar In Phase Two the investigators will conduct a small pilot study that examines the acceptability appropriateness and feasibility of the adapted Mothers and Babies intervention Specifically the investigators will deliver the adapted intervention to 10 women receiving prenatal care at Sidra Medicine In Phase Three the investigators will conduct a randomized controlled trial n 210 to determine the effectiveness of the adapted Mothers and Babies intervention on depressive symptoms anxiety symptoms and perceived stress among women receiving prenatal care at Sidra Medicine As part of the randomized controlled trial the investigators will recruit a sub-group of 40 women with diabetes given the high prevalence of diabetes among women in Qatar and the negative outcomes associated with diabetes on mother and child The investigators will explore whether the cognitive-behavioral techniques in Mothers and Babies are effective not only in promoting better mental health outcomes among this subgroup but also better diabetes self-management
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None