NCT03880032: HMHB

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

Completed NA Results posted Last updated 15 February 2024

What this trial tests

NA trial testing Cognitive Behavioral Therapy Intervention for Anxiety in Postpartum Depression in 1,200 participants. Completed in 7 October 2022.

Timeline

16 April 2019

Primary endpoint
7 October 2022

7 October 2022

Quick facts

Lead sponsor	Johns Hopkins Bloomberg School of Public Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	1,200
Start date	16 April 2019
Primary completion	7 October 2022
Estimated completion	7 October 2022
Sites	1 location across Pakistan

Drugs / interventions tested

• Cognitive Behavioral Therapy Intervention for Anxiety

Conditions studied

• Postpartum Depression — all drugs for Postpartum Depression →
• Small for Gestational Age at Delivery — all drugs for Small for Gestational Age at Delivery →
• Preterm Birth — all drugs for Preterm Birth →
• Anxiety — all drugs for Anxiety →

Sponsor

Johns Hopkins Bloomberg School of Public Health

Who can join

18 and older, female only, with Postpartum Depression or Small for Gestational Age at Delivery. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Combined Common Mental Disorders (CMDs, i.e. Anxiety and Depression). Primary · 6 weeks postpartum

Data reported is the number of participants with Common Mental Disorders (CMDs), which is defined as a woman having either high anxiety or clinical depression at the time of follow-up. Both CMDs, anxiety was indicated by moderate to severe symptoms on the anxiety portion of the Hospital and Anxiety Scale (HADS). A cutoff of \>10 was used as the threshold for moderate to severe levels of anxiety. A Major Depressive Episode (MDE) was measured with the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (SCID), which is a semi-structured interview used to m

Group	Value	95% CI
Cognitive Behavioral Therapy Intervention for Anxiety	57
Enhanced Usual Care	178

Number of Preterm Births Secondary · at birth

Number of infants born with \<37 weeks' gestation

Group	Value	95% CI
Cognitive Behavioral Therapy Intervention for Anxiety	79
Enhanced Usual Care	68

Small-for-gestational Age Birth Secondary · at birth

\<10th% for gestational age at birth compared to the reference population

Group	Value	95% CI
Cognitive Behavioral Therapy Intervention for Anxiety	89
Enhanced Usual Care	105

Low Birthweight Secondary · at birth

weight of ≤2500 grams

Group	Value	95% CI
Cognitive Behavioral Therapy Intervention for Anxiety	46
Enhanced Usual Care	53

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cognitive Behavioral Therapy Intervention for Anxiety

Serious: 48/600 (8%)

Deaths: 0/600

Enhanced Usual Care

Serious: 42/600 (7%)

Deaths: 0/600

Serious adverse events (1 terms)

Reaction	System	Cognitive Behavioral Thera…	Enhanced Usual Care
Serious Adverse Event	Injury, poisoning and procedural complications	—	—

Most-reported serious reactions: Serious Adverse Event.

Data from ClinicalTrials.gov NCT03880032 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.