CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,200 enrolled
Drug / intervention
Cognitive Behavioral Therapy Intervention for Anxietybehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03880032
NCT03880032N/ACompleted

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

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Mar 19, 2019·Updated Feb 15, 2024

In Brief

A clinical study evaluating Cognitive Behavioral Therapy Intervention for Anxiety for Postpartum Depression and 4 related conditions. Completed, enrolled 1,200 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPakistan

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 19, 2019
Enrollment StartApr 16, 2019
Primary CompletionOct 7, 2022
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 7.3 years ago

Interventions

Cognitive Behavioral Therapy Intervention for Anxietybehavioral

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.