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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 11, 2019
Sponsor:
Collaborators:
Brain & Behavior Research Foundation
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Perinatal Anxiety Other: Coping with Anxiety through Living Mindfully (CALM) Pregnancy

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Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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
Participants' blood will be drawn (up to 55 ml) at all four sessions by a study clinician or a trained research assistant. Blood will be collected in sodium-heparin tubes for immune cell preparation. Peripheral blood mononuclear cell (PBMC) suspensions will be prepared within 8 hours of blood collection by low-density gradient centrifugation via a Hermle Z 300 K #55085010, to avoid erythrophagy-related activation of the monocytes. PBMCs will be frozen and stored at -80° C using 10% dimethylsulfoxide, thereby allowing all samples to be analyzed in parallel.

Eligibility Criteria
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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
Study Population
Pregnant Women with or without mental health history.
Criteria

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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03664128


Contacts
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Contact: Lauren Osborne, MD 410-955-9986 lmosborne@jhmi.edu
Contact: Samantha Meilman, LCSW-C 410-502-2586 smeilma1@jhmi.edu

Locations
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United States, Maryland
Women's Mood Disorders Center Recruiting
Baltimore, Maryland, United States, 21205
Contact: Samantha Meilman, LCSW-C         
Sponsors and Collaborators
Johns Hopkins University
Brain & Behavior Research Foundation
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Lauren Osborne, MD Johns Hopkins University
More Information
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Additional Information:
Hintze, J. PASS 12. 2013. NCSS, LLC. Kaysville, Utah, USA  This link exits the ClinicalTrials.gov site

Publications:
74 Diggle P, Heagerty P, Liang K-Y, and Zeger S. Analysis of Longitudinal Data. 2nd edition. Oxford Statistical Science Series: 25. Oxford: Oxford University Press, 2002.
49. Kasper, S., den Boer, J.A., Ad Sitsen, J.M., 2003. Handbook of Depression and Anxiety: A Biological Approach, 2nd Ed. Marcel Dekker Inc., New York.
72. Segal ZV, Williams JM, Teasdale JD (2002) Mindfulness-based cognitive therapy for depression. Guilford, New York
73. Segal ZV, Williams JM, Teasdale JD (2013) Mindfulness-based cognitive therapy for depression second edition. Guilford, New York

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03664128     History of Changes
Other Study ID Numbers: IRB00087653
1K23MH110607-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No