NCT03880032

Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention

Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention for the Prevention of Common Mental Disorders in Pakistan

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,200 (actual)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

In the proposed study the investigators will develop an early prenatal preventive intervention targeting anxiety and conduct a randomized controlled trial in Pakistan to test its efficacy in reducing generalized anxiety disorder and major depression in mothers in late pregnancy and the postnatal period. Investigators will evaluate the impact of the intervention on fetal and infant growth restriction as well as examine how the impact of the intervention is mediated (to elucidate mechanisms) and/or modified (to help optimize future adaptations of the program) by various social factors. A cost-effectiveness evaluation will shed light on the costs and benefits of intervention components in relation to outcomes, enabling policy-makers and public health planners to scale up this intervention according to resource budgeting requirements.

Detailed description

Common mental disorders (CMDs) such as anxiety and depression occur frequently in pregnancy and the postnatal period in lower- and middle income countries (LMICs). Prenatal anxiety, both subthreshold and clinical, adversely affects maternal wellbeing and outcomes among offspring, and is a major predictor of subsequent depression. Preventive approaches have enormous potential to reduce the negative effects of postnatal mental disorders in mothers and improve child outcomes. The study team proposes to create a scalable and sustainable early prevention intervention focusing on anxiety symptoms in pregnant women, to be delivered by non-specialist providers (Aim 1). The investigators will evaluate this preventive intervention through a trial by randomizing 1200 pregnant women from a public hospital in Islamabad Pakistan to either our Cognitive Behavioral Therapy-based (CBT-based) early-in-pregnancy program or to usual care. The investigators will study the effects of the intervention on 1) CMDs in the 3rd trimester of pregnancy and at 6 weeks postpartum (Aim 2) and on 2) fetal and newborn small-for-gestational age (SGA) outcomes (Aim 3). The investigators will also examine if interpersonal violence, perceived stress and social support mediate and/or modify the intervention effects on CMDs and perinatal outcomes (Aim 4). Finally, the investigators will conduct a cost-effectiveness evaluation, comparing costs and healthcare utilization for women in the prenatal intervention and enhanced usual care groups (Aim 5). Focusing on anxiety reduction is a major innovation; anxiety has not been addressed within prenatal intervention packages in LMICs, despite its association with increased postpartum depression and suboptimal fetal and infant outcomes. Pakistan has high prevalence of both women with prenatal anxiety (35% to 49%) and SGA newborns (\~47%), providing an ideal research opportunity. The CBT-based approach, appropriate given its indication for anxiety and depression, is grounded in preliminary work in this population, where the investigators have previously successfully reduced postpartum depression. Intervening early in pregnancy is a further innovation that is critical for building the evidence base for preventative approaches to reduce maternal CMDs and related perinatal outcomes. The proposed mediation and effect modification analyses will improve understanding of mechanism(s) of action and help identify subpopulations for programmatic targeting. The use of non-specialized providers and integration within the primary care environment will guide scale up, while incorporating a cost-effectiveness analysis will aid policy-makers in resource allocation decisions. This study will inform the integration of preventive strategies that target anxiety with existing approaches for treatment of perinatal depression to further the evidence-base for transdiagnostic mental health initiatives globally, and will inform policies to support lifelong maternal mental health and resilience across generations

Conditions

• Postpartum Depression
• Small for Gestational Age at Delivery
• Preterm Birth
• Anxiety
• Birth Weight

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy Intervention for Anxiety	Happy Mother Healthy Baby (HMHB) is a CBT-based psychosocial intervention for expectant women experiencing anxiety during their pregnancy. Strategies such as empathetic listening, thought challenging, behavior activation, problem management, take-home exercises, and family involvement are employed by HMHB.

Timeline

• Start date: 2019-04-16
• Primary completion: 2022-10-07
• Completion: 2022-10-07
• First posted: 2019-03-19
• Last updated: 2024-02-15
• Results posted: 2024-02-15

Locations

1 site across 1 country: Pakistan