N/A
N=1,200
Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention
Postpartum Depression · Small for Gestational Age at Delivery · Preterm Birth · Anxiety · Birth Weight
Bottom Line
View on ClinicalTrials.gov: NCT03880032 ↗Enrolled (actual)
1,200
Serious AEs
7.5%
Results posted
Feb 2024
Primary outcome: Primary: Number of Participants With Combined Common Mental Disorders (CMDs, i.e. Anxiety and Depression). — 57; 178 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Behavioral Therapy Intervention for Anxiety (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Combined Common Mental Disorders (CMDs, i.e. Anxiety and Depression). |
57; 178 | — |
| SECONDARY Number of Preterm Births |
79; 68 | — |
| SECONDARY Small-for-gestational Age Birth |
89; 105 | — |
| SECONDARY Low Birthweight |
46; 53 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03880032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.