CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 157 enrolled
Drug / intervention
Coping with Anxiety through Living Mindfully (CALM) Pregnancyother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03664128
NCT03664128N/ACompleted

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

Johns Hopkins University·observational·Posted Sep 10, 2018·Updated Jan 10, 2023

In Brief

An observational study evaluating Coping with Anxiety through Living Mindfully (CALM) Pregnancy for Perinatal Anxiety. Completed, enrolled 157 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedSep 10, 2018
Enrollment StartJun 24, 2016
Primary CompletionNov 28, 2022
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 7.8 years ago

Interventions

Coping with Anxiety through Living Mindfully (CALM) Pregnancyother

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