Pregnancy and Anxious Thoughts: The Role of the Immune and Endocrine Systems
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ClinicalTrials.gov Identifier: NCT03664128 |
Recruitment Status :
Recruiting
First Posted : September 10, 2018
Last Update Posted : September 28, 2021
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Condition or disease | Intervention/treatment |
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Perinatal Anxiety | Other: Coping with Anxiety through Living Mindfully (CALM) Pregnancy |

Study Type : | Observational |
Estimated Enrollment : | 200 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Pregnancy and Anxious Thoughts: The Role of the Immune and Endocrine Systems |
Actual Study Start Date : | June 24, 2016 |
Estimated Primary Completion Date : | June 15, 2022 |
Estimated Study Completion Date : | June 15, 2022 |

Group/Cohort | Intervention/treatment |
---|---|
pregnant women positive for anxiety
100 pregnant women who screen positive for anxiety symptoms (>21 on the Perinatal Anxiety Screening Scale). Participants are matched for age, parity, and gestational age at enrollment. Coping with Anxiety through Living Mindfully (CALM) Pregnancy: Mindfulness-based Cognitive Behavioral Therapy (CBT) for perinatal anxiety on a subset (8 participants) |
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 |
healthy pregnant controls
100 matched healthy pregnant women. Participants are matched for age, parity, and gestational age at enrollment.
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- Changes in the level of interleukin 6 (IL-6) [ Time Frame: 4 study visits: 1) 22-26 weeks gestation; 2) 32-36 weeks gestation; 3) 6 weeks postpartum; 4) 6 months postpartum ]The MesoScale Discovery Pro-Inflammatory Multiplex Assay will be used to measure concentrations of IL-6 in pg/mL. Concentration will be log-transformed.
- Changes in the level of Interleukin 15 (IL-15) [ Time Frame: 4 study visits: 1) 22-26 weeks gestation; 2) 32-36 weeks gestation; 3)6 weeks postpartum; 4) 6 months postpartum ]The MesoScale Discovery Pro-Inflammatory Multiplex Assay will be used to measure concentrations of IL-15 in pg/mL. Concentration will be log-transformed.
- Changes in the level of Granulocyte macrophage colony stimulating factor (GM-CSF) [ Time Frame: 4 study visits: 1) 22-26 weeks gestation; 2) 32-36 weeks gestation; 3)6 weeks postpartum; 4) 6 months postpartum ]The MesoScale Discovery Pro-Inflammatory Multiplex Assay will be used to measure concentrations of GM-CSF in pg/mL. Concentration will be log-transformed.
- Changes in the level of Granulocyte colony stimulating factor (G-CSF) [ Time Frame: 4 study visits: 1) 22-26 weeks gestation; 2) 32-36 weeks gestation; 3)6 weeks postpartum; 4) 6 months postpartum ]The MesoScale Discovery Pro-Inflammatory Multiplex Assay will be used to measure concentrations of G-CSF in pg/mL. Concentration will be log-transformed.
- Changes in the level of Chemokine C-X-C motif ligand 8 (CXCL8) [ Time Frame: 4 study visits: 1) 22-26 weeks gestation; 2) 32-36 weeks gestation; 3)6 weeks postpartum; 4) 6 months postpartum ]The MesoScale Discovery Pro-Inflammatory Multiplex Assay will be used to measure concentrations of C-X-CL8 in pg/mL. Concentration will be log-transformed.
- Changes in the level of Chemokine C-C motif ligand 3 (CCL3) [ Time Frame: 4 study visits: 1) 22-26 weeks gestation; 2) 32-36 weeks gestation; 3)6 weeks postpartum; 4) 6 months postpartum ]The MesoScale Discovery Pro-Inflammatory Multiplex Assay will be used to measure concentrations of CCL3 in pg/mL. Concentration will be log-transformed.
- Leukocyte subpopulation [ Time Frame: Second study visit (32-36 weeks gestation) ]The investigators will use flow cytometry and fluorescence activated cell-sorting analysis to determine the percentages of leukocyte subpopulations, namely T cells, B cells, natural killer cells, monocytes, macrophages, and dendritic cells.
- Relationship of changes in levels of allopregnanolone (ALLO) to pro-inflammatory markers [ Time Frame: 1st and 2nd study visits: 1) 22-26 weeks gestation; 2) 32-36 weeks gestation ]The investigators will use enzyme-linked immunosorbent assay (ELISA) to measure levels of ALLO in ng/mL, across pregnancy and calculate the rate of change across pregnancy to determine if there is any correlation between the level of ALLO at second and third trimesters and levels of the pro-inflammatory markers listed above.
- Heart Rate Variability [ Time Frame: Second study visit (32-36 weeks gestation) ]The investigators will measure high-frequency heart rate variability (in length of R to R interval in milliseconds, using electrocardiogram in Biopac Data Acquisition System) at baseline and in response to a stressor. This will be analyzed to see if there is a change comparing women with elevated inflammation and decreased ALLO to those without these features.
- Electrodermal Activity [ Time Frame: Second study visit (32-36 weeks gestation) ]The investigators will measure electrodermal activity on the hands at baseline and in response to a stressor, using Biopac Data Acquisition System and electrodermal activity electrodes. The investigators will analyze these data to assess any changes when comparing women with elevated inflammation and decreased ALLO to those without these features.
- Feasibility of a mindfulness-based cognitive behavioral therapy intervention as assessed by participant retention number [ Time Frame: Study visit (22-36 weeks gestation) ]The investigators will measure feasibility of this intervention by enrollment and retention of participants in a mindfulness-based cognitive behavioral therapy intervention for perinatal anxiety (CALM pregnancy). The intervention will be deemed feasible if the investigators successfully enroll at least 6 participants, and all participants complete at least 6 of the 8 sessions.
- Acceptability of a mindfulness-based cognitive behavioral therapy intervention as assessed by a Likert scale [ Time Frame: Study visit (22-36 weeks gestation) ]The investigators will measure acceptability of the CALM pregnancy intervention to participants using a Likert scale (1-5, with 1 being not at all acceptable and 5 being very acceptable).
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria for all:
- Pregnant and <27 weeks gestation
- Age 18 or above
- Able to provide written consent
- Healthy pregnancy.
Additional inclusion criteria specific to anxiety group:
- Significant anxiety symptoms as measured by a score of > 21 on the Perinatal Anxiety Screening Scale (PASS)
- a diagnosis of current anxiety disorder by Structured Clinical Interview for Diagnostic And Statistical Manual Of Mental Disorders (DSM) V Diagnoses (SCID), or a diagnosis of a current anxiety disorder by a clinician interview using DSM-V criteria.
Exclusion Criteria for all:
- Multifetal pregnancy
- Autoimmune or endocrine disease
- Meeting criteria for a major depressive episode at study entry
- Active suicidal ideation at study entry
- Bipolar disorder or primary psychotic disorder
- Recent or current substance abuse.
Additional exclusion criteria for healthy controls:
- No history of an anxiety or depressive disorder as determined by Structured Clinical Interview for DSM-V Diagnoses (SCID)
- No current use of an antidepressant.

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): NCT03664128
Contact: Lauren Osborne, MD | 410-955-9986 | lmosborne@jhmi.edu | |
Contact: Kristen Miller, MA | 410-502-2586 | kmill156@jhmi.edu |
United States, Maryland | |
Women's Mood Disorders Center | Recruiting |
Baltimore, Maryland, United States, 21205 | |
Contact: Samantha Meilman, LCSW-C |
Principal Investigator: | Lauren Osborne, MD | Johns Hopkins University |
Publications:
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT03664128 |
Other Study ID Numbers: |
IRB00087653 1K23MH110607-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | September 10, 2018 Key Record Dates |
Last Update Posted: | September 28, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |