TY - JOUR
T1 - Biological Mechanisms in Pregnant Women With Anxiety (Happy Mother-Healthy Baby Supplement Study)
T2 - Protocol for a Longitudinal Mixed Methods Observational Study
AU - Sherer, Morgan L.
AU - Malik, Abid
AU - Osborne, Lauren M.
AU - Rowther, Armaan A.
AU - Zaidi, Ahmed
AU - Atif, Najia
AU - Rahman, Atif
AU - Kahloon, Lubna E.
AU - Salman, Muhammad
AU - Yenokyan, Gayane
AU - Surkan, Pamela J.
N1 - Funding Information:
The authors wish to acknowledge all participants involved in the study. They wish to thank members of the Osborne Lab at Johns Hopkins University for their assistance in coordinating sample shipments and study protocols. All work in this manuscript, including design, data collection, analysis, and interpretation, was supported by the NIMH at the US National Institutes of Health grant RO1 MH111859-01. LMO’s time was additionally supported by NIH-NIMH K23 MH110607 and MLS’ by NIH-NIAID T32 AI007417.
Publisher Copyright:
© Morgan L Sherer, Abid Malik, Lauren M Osborne, Armaan A Rowther, Ahmed Zaidi, Najia Atif, Atif Rahman, Lubna E Kahloon, Muhammad Salman, Gayane Yenokyan, Pamela J Surkan.
PY - 2023
Y1 - 2023
N2 - Background: Anxiety and depression are common in the perinatal period and negatively affect the health of the 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 (LMICs). Objective: The purpose of this study is to examine biological mechanisms that may be linked to perinatal anxiety in conjunction with a randomized controlled trial of HMHB in Pakistan. Methods: We are recruiting 120 pregnant women from the Holy Family Hospital, a public facility in Rawalpindi, Pakistan. Participants are assessed for at least mild anxiety symptoms using the Hospital Anxiety and Depression Scale (ie, a 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 the 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 4 time points (baseline, second trimester, third trimester, and 6 weeks post partum). We will assess peripheral cytokine concentrations using a multiplex assay and hormone concentrations using gas chromatography and mass spectrometry. The statistical analysis will use 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 completed 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 at ClinicalTrials.gov (NCT03880032) on September 22, 2020. The last blood samples were shipped to the United States on September 24, 2022, where they will be processed for analysis. 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 nonspecialist providers and, if effective, will represent an important new tool for the treatment of antenatal anxiety in LMICs. Our biological substudy is one of the first attempts to link biological mechanisms to antenatal anxiety in an 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 treatment efficacy.
AB - Background: Anxiety and depression are common in the perinatal period and negatively affect the health of the 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 (LMICs). Objective: The purpose of this study is to examine biological mechanisms that may be linked to perinatal anxiety in conjunction with a randomized controlled trial of HMHB in Pakistan. Methods: We are recruiting 120 pregnant women from the Holy Family Hospital, a public facility in Rawalpindi, Pakistan. Participants are assessed for at least mild anxiety symptoms using the Hospital Anxiety and Depression Scale (ie, a 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 the 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 4 time points (baseline, second trimester, third trimester, and 6 weeks post partum). We will assess peripheral cytokine concentrations using a multiplex assay and hormone concentrations using gas chromatography and mass spectrometry. The statistical analysis will use 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 completed 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 at ClinicalTrials.gov (NCT03880032) on September 22, 2020. The last blood samples were shipped to the United States on September 24, 2022, where they will be processed for analysis. 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 nonspecialist providers and, if effective, will represent an important new tool for the treatment of antenatal anxiety in LMICs. Our biological substudy is one of the first attempts to link biological mechanisms to antenatal anxiety in an 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 treatment efficacy.
KW - Pakistan
KW - allopregnanolone
KW - antenatal anxiety
KW - cognitive behavioral therapy
KW - inflammation
KW - perinatal anxiety
KW - pregnancy
KW - randomized controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85158888655&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85158888655&partnerID=8YFLogxK
U2 - 10.2196/43193
DO - 10.2196/43193
M3 - Article
C2 - 37040167
AN - SCOPUS:85158888655
SN - 1929-0748
VL - 12
JO - JMIR Research Protocols
JF - JMIR Research Protocols
M1 - e43193
ER -