Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention (NCT03880032) | Clinical Trial Compass
CompletedNot Applicable
Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention
Pakistan1,200 participantsStarted 2019-04-16
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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)
What they're measuring
1
Number of Participants With Combined Common Mental Disorders (CMDs, i.e. Anxiety and Depression).
Timeframe: 6 weeks postpartum
Trial details
NCT IDNCT03880032
SponsorJohns Hopkins Bloomberg School of Public Health