Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Anxiety
  • Diabetes
  • Postpartum Depression
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 50 years
Gender
Only males

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 po...

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 = 160) 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.

Tracking Information

NCT #
NCT04442529
Collaborators
Northwestern University
Investigators
Not Provided