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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
Sponsor:
Collaborators:
Human Development Research Foundation, Pakistan
Rawalpindi Medical College, Pakistan
University of Liverpool
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anxiety Behavioral: Cognitive Behavioral Therapy (CBT) for anxiety during pregnancy Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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


Secondary Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women and their children
Accepts Healthy Volunteers:   Yes
Criteria

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 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)

Information from the National Library of Medicine

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


Contacts
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Contact: Pamela J Surkan, ScD 410-502-7396 psurkan@jhu.edu
Contact: Abid Malik, MD, PhD 92-346-854-4463 abid.malik@hdrffoundation.org

Locations
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Pakistan
Holy Family Hospital Recruiting
Rawalpindi, Pakistan
Contact: Abid Malik, MD, PhD         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Human Development Research Foundation, Pakistan
Rawalpindi Medical College, Pakistan
University of Liverpool
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Pamela J Surkan, ScD Johns Hopkins Bloomberg School of Public Health
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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT04566861    
Other Study ID Numbers: 3R01MH111859-03S1 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified project data from the study will be posted on ClinicalTrials.gov and the National Institute of Mental Health (NIMH) data archive.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: The study protocol, statistical analysis plan and informed consent form are available upon request now.
Access Criteria: The can be access upon request from the study PI: psurkan@jhu.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
randomized controlled trial
inflammation
hormones
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders