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Pregnancy and Anxious Thoughts: The Role of the Immune and Endocrine Systems

NCT03664128 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 157

Last updated 2023-01-10

No results posted yet for this study

Summary

The aim of the proposed research is to identify the clinical and biological phenotypes that define perinatal anxiety. The importance of this research to public health is that it will help to identify women at high risk, and will also serve as the basis for further studies that would identify genetic and epigenetic markers of risk and lead to research to identify novel treatment targets. The research is based upon preliminary data demonstrating a relationship between inflammatory cytokines and Trait anxiety in pregnancy; between progesterone and postpartum anxiety; and between allopregnanolone and obsessive symptoms in pregnancy. The proposed research will build upon these preliminary findings by prospectively examining the clinical features of anxiety in a cohort of pregnant women and healthy matched controls, and by analyzing blood samples from the same cohort for inflammatory cytokines, reproductive hormones, and immune cell types. The proposed study will therefore identify the clinical and biological phenotypes that characterize perinatal anxiety and will identify potential novel targets for treatment.

Conditions

  • Perinatal Anxiety

Interventions

OTHER

Coping with Anxiety through Living Mindfully (CALM) Pregnancy

Mindfulness-based Cognitive Behavioral Therapy (CBT) for perinatal anxiety on a subset (8 participants); no intervention for other participants

Sponsors & Collaborators

  • Brain & Behavior Research Foundation

    collaborator OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Lauren Osborne, MD · Johns Hopkins University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-24
Primary Completion
2022-11-28
Completion
2022-11-28

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03664128 on ClinicalTrials.gov