Happy Mother - Healthy Baby: Supplement Study on Biological Processes Underlying Anxiety During Pregnancy (HMHB-Bio)
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|ClinicalTrials.gov Identifier: NCT04566861|
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : February 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Anxiety||Behavioral: Cognitive Behavioral Therapy (CBT) for anxiety during pregnancy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Within women in a larger randomized trial (randomized to the intervention or enhanced care group), we propose to 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), we will also include 100 healthy women without anxiety or depression.|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||The principal investigators and outcomes assessors will be blind to the randomization status of the 200 anxious women assigned to the intervention and enhanced usual care groups.|
|Primary Purpose:||Basic Science|
|Official Title:||Biological Processes Underlying Anxiety During Pregnancy: A Substudy of an Anxiety-focused Early Prenatal Intervention for the Prevention of Common Mental Disorders in Pakistan|
|Actual Study Start Date :||October 20, 2020|
|Estimated Primary Completion Date :||February 1, 2022|
|Estimated Study Completion Date :||October 1, 2022|
Experimental: Anxious pregnant women - intervention group
100 pregnant women who have at least mild anxiety will be randomized to the intervention group where they will receive six one-on-one core sessions of Cognitive Behavioral Therapy during pregnancy (plus possible booster sessions)
Behavioral: Cognitive Behavioral Therapy (CBT) for anxiety during pregnancy
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.
No Intervention: Anxious pregnant women - enhanced usual care group
100 pregnant women who have at least mild anxiety will be randomized to the enhanced usual care group. They will not receive intervention sessions but will receive transportation vouchers to come to the hospital and facilitation by study staff to attend to their regular antenatal care visits.
No Intervention: Non-anxious pregnant women - healthy control
100 pregnant women who do not have symptoms of anxiety or depression be followed in the healthy control group. They will not receive intervention sessions but will receive transportation vouchers to come to the hospital and facilitation by study staff to attend to their regular antenatal care visits.
- Peripheral markers of inflammation [ Time Frame: during pregnancy until six weeks postpartum ]We will measure differences in levels of peripheral inflammatory markers and change in these markers across time between anxious and healthy women, and between intervention and control women. Markers include IL-6, CCL3, CXCL8, Eotaxin, VEGF, and GM-CSF
- Allopregnanolone levels and anxiety symptoms across the peripartum [ Time Frame: during pregnancy until six weeks postpartum ]We will measure differences in level of allopregnanolone at each time point and across time between anxious women and healthy women, and between intervention and control
- Allopregnanolone levels predicting postpartum depression [ Time Frame: during pregnancy until birth ]We will measure differences in allopregnanolone levels at the second trimester between women who do and do not go on to develop postpartum depression.
- Allopregnanolone and immune function [ Time Frame: through pregnancy until six weeks postpartum ]We will measure the relationship between ALLO levels and levels of peripheral inflammatory markers across time, both concurrent and predictive
- Birth outcomes [ Time Frame: through pregnancy and at birth ]We will measure differences in birth outcomes (preterm birth, small or large 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.
- Infant neurodevelopment [ Time Frame: through pregnancy up to and including 6 weeks postpartum ]We will measure differences in infant neurodevelopment using a standardized questionnaire between those high in inflammatory markers vs. those low, and also between anxious and healthy women
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04566861
|Contact: Pamela J Surkan, ScDfirstname.lastname@example.org|
|Contact: Abid Malik, MD, PhDemail@example.com|
|Holy Family Hospital||Recruiting|
|Contact: Abid Malik, MD, PhD|
|Principal Investigator:||Pamela J Surkan, ScD||Johns Hopkins Bloomberg School of Public Health|