Happy Mother - Healthy Baby: Supplement Study on Biological Processes Underlying Anxiety During Pregnancy

Johns Hopkins Bloomberg School of Public Health117 enrolled

Overview

As a supplement to the ongoing randomized evaluation of the Cognitive Behavioral Therapy (CBT) anxiety prevention intervention in Pakistan (R01-MH111859), the investigators propose to explore potential biological mechanisms (related to inflammation and endocrine functioning) of antenatal anxiety through additional data collection with 300 pregnant women.

This study will leverage the ongoing randomized evaluation of the CBT anxiety prevention intervention in Pakistan (R01-MH111859) to explore potential biological mechanisms. This CBT intervention targets both sub-threshold anxiety symptoms and generalized anxiety disorder (GAD) in early- to mid- pregnancy, aiming to both prevent and treat Common Mental Disorders (CMDs) (GAD and major depressive episodes (MDE)) as well as improve birth outcomes. The study team proposes to additionally study biological correlates of antenatal anxiety (i.e., immune and endocrine functioning) in 300 women: in addition to 200 drawn from our randomized trial (100 intervention, 100 usual care), the study will also include 100 healthy women without anxiety or depression. The aims are to 1) characterize the "immune phenotype" of anxious women across the peripartum, specifically by measuring the relation among anxiety symptoms and peripheral markers of inflammation within and across women (both anxious and healthy) and between those receiving the intervention and control; 2) determine the relation between levels of allopregnanolone (ALLO) in pregnancy and concurrent anxiety symptoms and future symptoms of postpartum depression (PPD), 3) examine the relation between changes in immune functioning and ALLO levels in anxious pregnancy across time, 4) examine whether immune function and/or ALLO are mediators or moderators of the association between antenatal anxiety and preterm birth and/or small-for-gestational age, and 5) examine the effects of both anxiety and the intervention (including biomarkers) on infant development at six weeks postpartum.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

117

Conditions

Anxiety

Interventions

Cognitive Behavioral Therapy (CBT) for anxiety during pregnancyBEHAVIORAL

Women who are randomized to the intervention group will receive six core Cognitive Behavioral Therapy (CBT) sessions for anxiety during pregnancy (and possible booster sessions) to treat symptoms of anxiety.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 Exclusion Criteria: * Current anemia * Current major 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)

Locations (1)

Holy Family Hospital

Rawalpindi, Pakistan

Outcomes

Primary Outcomes

Peripheral Markers of Inflammation

Differences in levels of peripheral inflammatory markers and change in these markers across time (trimester 1 (T1), trimester 2 (T2), trimester 3 (T3) and postpartum (PP)) between anxious and healthy women, and between intervention and control women. Markers include IFNgamma, IL6, IL8, IL10, IL12p70, TNFalpha, IL17A, TARC, MIP1alpha, MCP4, Eotaxin

Time frame: trimester 1, trimester 2, trimester 3, 6 weeks postpartum

Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum

Measure differences in level of allopregnanolone (mean) at each time point and across time (trimester 1 (T1), trimester 2 (T2), trimester 3 (T3) and postpartum (PP)) between anxious women and healthy women, and between intervention and control. The results are measured by log-transformed values of the concentration of each cytokine in the plasma, in ng/mL (nanogram per milliliter).

Time frame: trimester 2, trimester 3, 6 weeks postpartum

Allopregnanolone Levels Predicting Postpartum Depression

Differences in allopregnanolone levels at the second trimester between women who do and do not go on to develop postpartum depression (PPD). The results are measured by log-transformed values of the concentration of allopregnanolone in the plasma, in ng/ml (nanogram per milliliter. Women who have Allopregnanolone (ALLO) levels and developed PPD are analyzed.

Time frame: Trimester 2

Allopregnanolone (ALLO) and Immune Function

Measure the relationship between ALLO levels and levels of peripheral inflammatory markers across time (trimester 2 (T2), trimester 3 (T3) and 6 weeks postpartum (W6))

Time frame: trimester 2, trimester 3, 6 weeks postpartum

Secondary Outcomes

Birth Outcomes

Differences in birth outcomes (preterm birth, small for gestational age, low birth weight) between women with high inflammatory markers vs. those low in inflammatory markers, and also between anxious and healthy women.

Data from ClinicalTrials.gov

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