JMIR Publications

ABSTRACT

Background:

Anxiety and depression are common in the perinatal period and negatively affect the health of mother and baby. Our group has developed “Happy Mother-Healthy Baby” (HMHB), a cognitive behavioral therapy-based psychosocial intervention to address risk factors specific to anxiety during pregnancy in low- and middle-income countries.

Objective:

In conjunction with a randomized controlled trial (RCT) of HMHB in Pakistan, we aim to examine biological mechanisms that may be linked to perinatal anxiety and the intervention.

Methods:

We are recruiting 120 pregnant women from the Holy Family Hospital (HFH), a public facility in Rawalpindi, Pakistan. Participants are assessed for at least mild anxiety symptoms using the Hospital Anxiety Depression Scale (HADS) (i.e., score ≥8 on the anxiety scale is necessary for inclusion in the anxiety groups and <8 for inclusion in the healthy control group). Women who meet criteria for an anxiety group are randomized into either the HMHB Intervention group or an Enhanced Usual Care (EUC) control group. Participants receive HMHB or EUC throughout pregnancy and undergo blood draws at four timepoints (baseline, 2nd trimester, 3rd trimester, and 6 weeks postpartum). We will assess peripheral cytokine concentrations using a multiplex assay and hormone concentrations using gas chromatography and mass spectrometry (GC/MS). The statistical analysis will used Generalized Linear Models and Mixed Effects Models to assess the relationships across time among anxiety, immune dysregulation, and hormone levels, and to assess whether these biological factors mediate the relationship between anxiety and birth and child development outcomes.

Results:

Recruitment started on October 20, 2020 and data collection was complete on August 31, 2022. The start date for recruitment for this biological supplement study was delayed by approximately half a year due to the Covid-19 pandemic. The trial was registered in ClinicalTrials.gov (NCT03880032) on September 22, 2020. Currently, blood samples are being shipped to the US where they will be processed for analysis. The main trial is still in the follow-up phase.

Conclusions:

This study is an important addition to the HMHB randomized controlled trial of an intervention for antenatal anxiety. The intervention itself makes use of non-specialist providers and, if effective, will represent an important new tool for the treatment of antenatal anxiety in low- and middle-income countries (LMICs). Our biological sub-study is one of the first attempts to link biological mechanisms to antenatal anxiety in a LMIC in the context of a psychosocial intervention, and our findings have the potential to significantly advance our knowledge of the biological pathways of perinatal mental illness and of treatment efficacy. Clinical Trial: ClinicalTrials - NCT03880032