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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    1200
  • sponsor
    Johns Hopkins Bloomberg School of Public Health
Updated on 25 January 2021
depression
anxiety
behavior therapy
behavioral therapy
prenatal
depressive disorder
depressed mood
cognitive therapy
light therapy
anxiety disorder
generalized anxiety

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.

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

Details
Condition Birth Weight, Premature Birth, Postpartum depression, ANXIETY NEUROSIS, Anxiety, Anxiety Disorders (Pediatric), Generalized Anxiety Disorder (GAD), Premature, Generalized Anxiety Disorder (GAD - Pediatric), Post-Partum Depression, Anxiety Symptoms, Anxiety Disorders, Pre-Term, Small for Gestational Age at Delivery, anxiety disorder, preterm delivery, preterm birth, premature delivery, anxious
Treatment Cognitive Behavioral Therapy Intervention for Anxiety
Clinical Study IdentifierNCT03880032
SponsorJohns Hopkins Bloomberg School of Public Health
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

ability to understand spoken Urdu
pregnant, 22 weeks' gestation
age 18 years
residence 20 km of Holy Family Hospital
intent to reside in the study areas until the completion of the study
score 8 for anxiety on the Hospital Anxiety and Depression Scale (HADS)

Exclusion Criteria

Current major a depressive episode (MDE on SCID) or life-threatening health conditions including e.g. active severe depression or suicidal ideation
Self-report of past or current significant learning disability
Self-report of past or current psychiatric disorder (e.g. bipolar disorder or schizophrenia) or psychiatric care (e.g. current use of anxiolytic drug and/or other psychotropic drug)
medical disorders or severe maternal morbidity that require inpatient management that would preclude participation (101)
ICU admission indicated by diagnosis (not only for assessment)
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