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

NCT03664128 | Completed

• 2 other identifiers: IRB000876531K23MH110607-01A1
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Anxiety

Outcome Measures

Primary Outcomes (7)

• Changes in the level of interleukin 6 (IL-6)

  The MesoScale Discovery Pro-Inflammatory Multiplex Assay will be used to measure concentrations of IL-6 in pg/mL. Concentration will be log-transformed.

  4 study visits: 1) 22-26 weeks gestation; 2) 32-36 weeks gestation; 3) 6 weeks postpartum; 4) 6 months postpartum

• Changes in the level of Interleukin 15 (IL-15)

  The MesoScale Discovery Pro-Inflammatory Multiplex Assay will be used to measure concentrations of IL-15 in pg/mL. Concentration will be log-transformed.

  4 study visits: 1) 22-26 weeks gestation; 2) 32-36 weeks gestation; 3)6 weeks postpartum; 4) 6 months postpartum

• Changes in the level of Granulocyte macrophage colony stimulating factor (GM-CSF)

  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 study visits: 1) 22-26 weeks gestation; 2) 32-36 weeks gestation; 3)6 weeks postpartum; 4) 6 months postpartum

• Changes in the level of Granulocyte colony stimulating factor (G-CSF)

  The MesoScale Discovery Pro-Inflammatory Multiplex Assay will be used to measure concentrations of G-CSF in pg/mL. Concentration will be log-transformed.

  4 study visits: 1) 22-26 weeks gestation; 2) 32-36 weeks gestation; 3)6 weeks postpartum; 4) 6 months postpartum

• Changes in the level of Chemokine C-X-C motif ligand 8 (CXCL8)

  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.

  4 study visits: 1) 22-26 weeks gestation; 2) 32-36 weeks gestation; 3)6 weeks postpartum; 4) 6 months postpartum

• Changes in the level of Chemokine C-C motif ligand 3 (CCL3)

  The MesoScale Discovery Pro-Inflammatory Multiplex Assay will be used to measure concentrations of CCL3 in pg/mL. Concentration will be log-transformed.

  4 study visits: 1) 22-26 weeks gestation; 2) 32-36 weeks gestation; 3)6 weeks postpartum; 4) 6 months postpartum

• Leukocyte subpopulation

  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.

  Second study visit (32-36 weeks gestation)

Secondary Outcomes (5)

• Relationship of changes in levels of allopregnanolone (ALLO) to pro-inflammatory markers

  1st and 2nd study visits: 1) 22-26 weeks gestation; 2) 32-36 weeks gestation

• Heart Rate Variability

  Second study visit (32-36 weeks gestation)

• Electrodermal Activity

  Second study visit (32-36 weeks gestation)

• Feasibility of a mindfulness-based cognitive behavioral therapy intervention as assessed by participant retention number

  Study visit (22-36 weeks gestation)

• Acceptability of a mindfulness-based cognitive behavioral therapy intervention as assessed by a Likert scale

  Study visit (22-36 weeks gestation)

Study Arms (2)

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

healthy pregnant controls

100 matched healthy pregnant women. Participants are matched for age, parity, and gestational age at enrollment.

Interventions

Coping with Anxiety through Living Mindfully (CALM) Pregnancy OTHER

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

pregnant women positive for anxiety

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant Women with or without mental health history.

You may qualify if:

• Pregnant and \<27 weeks gestation
• Age 18 or above
• Able to provide written consent
• Healthy pregnancy.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Brain & Behavior Research Foundation: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Women's Mood Disorders Center

Baltimore, Maryland, 21205, United States

Location

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• Riddle JN, Jager LR, Sherer M, Pangtey M, Osborne LM. Anxiety in pregnancy and stress responsiveness: An exploratory study of heart rate variability, cortisol, and alpha-amylase in the third trimester. J Neuroendocrinol. 2023 Jul;35(7):e13238. doi: 10.1111/jne.13238. Epub 2023 Mar 3.

  PMID: 36866835 DERIVED

Related Links

• Hintze, J. PASS 12. 2013. NCSS, LLC. Kaysville, Utah, USA

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.

MeSH Terms

Interventions

Coping Skills; Pregnancy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Lauren Osborne, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 10, 2018
• Study Start: June 24, 2016
• Primary Completion: November 28, 2022
• Study Completion: November 28, 2022
• Last Updated: January 10, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)