Perinatal AnxietyNCT03664128
Pregnancy and Anxious Thoughts: The Role of the Immune and Endocrine Systems
An observational study of Perinatal Anxiety, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perinatal Anxiety
- What is being tested?
- Coping with Anxiety through Living Mindfully (CALM) Pregnancy
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2016to 28 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant Women with or without mental health history.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Women's Mood Disorders Center
Baltimore, Maryland, 21205
About this study
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.
Read the detailed description
My preliminary data from the Viral Immunity in Pregnancy Study found a strong association in 49 pregnant women between levels of anxiety and of cytokines. When the investigators controlled for clinical confounders, some of those associations disappeared - but there was still a strong correlation between anxiety score and the cytokine interleukin (IL) 6.
Hypothesis: Anxious pregnant women (as determined by a score > 21 on the Perinatal Anxiety Screening Scale (PASS)) will have elevated pro-inflammatory cytokines in pregnancy (at second and third trimesters) and will demonstrate greater continued elevation at 6 weeks and 6 months postpartum when compared to healthy controls. Leukocyte subpopulation analysis in anxious women will show a higher ratio of T-helper 1-type (Th1) to T-helper 2- type (Th2) cells and a greater monocyte activation across the perinatal period than that in healthy controls.
Hypothesis: There will be a negative correlation between allopregnanolone (ALLO) and pro-inflammatory markers (as listed above in primary outcome measure) in pregnancy, and between allopregnanolone (ALLO) in pregnancy and pro-inflammatory markers in the postpartum.
Hypothesis: Women with a pro-inflammatory immune fingerprint and low levels of allopregnanolone (ALLO) as determined by outcomes 1 and 2 will show increased attentional bias to threat, as demonstrated by measurement of autonomic reactivity in response to a validated pregnancy-specific modified Stroop task.
Hypothesis: Anxious pregnant women will find it feasible and acceptable to engage in a mindfulness-based cognitive behavioral therapy intervention for perinatal anxiety.
For each of these, the investigators will compare the outcome between anxious and non-anxious women.
The current study has 2 parts. The initial part, funded by Brain and Behavior Foundation, was designed to collect general information about the immune and endocrine mechanisms of perinatal anxiety and to test following aims:
Aim 1: To determine if obsessional anxiety in pregnancy corresponds to changes in immune functioning.
Aim 2: To determine if symptoms of obsessional anxiety in pregnancy are associated with changes in the levels of progesterone and its metabolites.
Aim 3: To determine feasibility and acceptability of mindfulness-based cognitive behavioral intervention designed to ameliorate prenatal anxiety and the accompanying inflammatory dysregulation.
I next expanded the study to obtain more detailed biological data; There is no intervention in the expansion for this phase.
I plan to recruit a group of 200 pregnant women (100 who screen positive for anxiety and 100 healthy controls). Subjects will answer questionnaires about mood and anxiety symptoms and have participants' blood drawn at four visits across pregnancy and the postpartum; in the second visit, participants will also perform a computer task designed to test how well participants can inhibit responses. A small subset of subjects will enroll in a group mindfulness intervention as well. This study is designed to achieve the following aims:
- To compare the "immune fingerprint" of women with significant perinatal anxiety with that of a cohort of healthy matched controls.
- To determine how perinatal changes in the "immune fingerprint" relate to changes in levels of progesterone metabolites (specifically, allopregnanolone) across pregnancy.
- To identify how changes in the "immune fingerprint" and progesterone metabolites are related to changes in maternal response to threat.
This study is an effort to further characterize the role of the immune system in common psychiatric symptomatology and the likely bidirectional relationship between the immune system and reproductive hormones that may be related to disease flares among a subset of patients. This work could eventually extend to the gene signatures responsible for immune pathways, to epigenetic studies, and/or to brain imaging studies examining differences in brain region function as affected by inflammation. Ultimately, this would allow the investigators to augment the traditional psychopharmacological focus on serotonin modification with new treatment targets, including cytokines, intracellular inflammatory mediators, neurogenesis, or glial cell activation.
- Conditions
- Perinatal Anxiety
- Being tested
- Coping with Anxiety through Living Mindfully (CALM) Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Second study visit (32-36 weeks gestation)
Secondary outcomes (5)
Relationship of changes in levels of allopregnanolone (ALLO) to pro-inflammatory markers
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.
Measured: 1st and 2nd study visits: 1) 22-26 weeks gestation; 2) 32-36 weeks gestation
Heart Rate Variability
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.
Measured: Second study visit (32-36 weeks gestation)
Electrodermal Activity
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.
Measured: Second study visit (32-36 weeks gestation)
Feasibility of a mindfulness-based cognitive behavioral therapy intervention as assessed by participant retention number
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.
Measured: Study visit (22-36 weeks gestation)
Acceptability of a mindfulness-based cognitive behavioral therapy intervention as assessed by a Likert scale
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).
Measured: Study visit (22-36 weeks gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start24 Jun 2016
- Primary completion28 Nov 2022
- Study completion28 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (75)Papers the sponsor has linked to this study.
- Other trials for Perinatal AnxietyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Lauren Osborne, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664128
- Sponsor's protocol ID
- IRB00087653
- Other IDs
- 1K23MH110607-01A1
- Status last verified
- Jun 2022
- First submitted
- 6 Sep 2018
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alder J, Fink N, Bitzer J, Hosli I, Holzgreve W. Depression and anxiety during pregnancy: a risk factor for obstetric, fetal and neonatal outcome? A critical review of the literature. J Matern Fetal Neonatal Med. 2007 Mar;20(3):189-209. doi: 10.1080/14767050701209560.
PubMed 17437220Andersson L, Sundstrom-Poromaa I, Wulff M, Astrom M, Bixo M. Implications of antenatal depression and anxiety for obstetric outcome. Obstet Gynecol. 2004 Sep;104(3):467-76. doi: 10.1097/01.AOG.0000135277.04565.e9.
PubMed 15339755Ashley V, Honzel N, Larsen J, Justus T, Swick D. Attentional bias for trauma-related words: exaggerated emotional Stroop effect in Afghanistan and Iraq war veterans with PTSD. BMC Psychiatry. 2013 Mar 14;13:86. doi: 10.1186/1471-244X-13-86.
PubMed 23496805Bar-Shai M, Gott D, Kreinin I, Marmor S. Atypical presentations of pregnancy-specific generalized anxiety disorders in women without a previous psychiatric background. Psychosomatics. 2015 May-Jun;56(3):286-91. doi: 10.1016/j.psym.2013.12.017. Epub 2014 Jan 1. No abstract available.
PubMed 25262048Backstrom T, Bixo M, Johansson M, Nyberg S, Ossewaarde L, Ragagnin G, Savic I, Stromberg J, Timby E, van Broekhoven F, van Wingen G. Allopregnanolone and mood disorders. Prog Neurobiol. 2014 Feb;113:88-94. doi: 10.1016/j.pneurobio.2013.07.005. Epub 2013 Aug 23.
PubMed 23978486Baer AN, Witter FR, Petri M. Lupus and pregnancy. Obstet Gynecol Surv. 2011 Oct;66(10):639-53. doi: 10.1097/OGX.0b013e318239e1ee.
PubMed 22112525Bergink V, Burgerhout KM, Weigelt K, Pop VJ, de Wit H, Drexhage RC, Kushner SA, Drexhage HA. Immune system dysregulation in first-onset postpartum psychosis. Biol Psychiatry. 2013 May 15;73(10):1000-7. doi: 10.1016/j.biopsych.2012.11.006. Epub 2012 Dec 25.
PubMed 23270599Biggio G, Pisu MG, Biggio F, Serra M. Allopregnanolone modulation of HPA axis function in the adult rat. Psychopharmacology (Berl). 2014 Sep;231(17):3437-44. doi: 10.1007/s00213-014-3521-6.
PubMed 24658404Brunton PJ. Neuroactive steroids and stress axis regulation: Pregnancy and beyond. J Steroid Biochem Mol Biol. 2016 Jun;160:160-8. doi: 10.1016/j.jsbmb.2015.08.003. Epub 2015 Aug 7.
PubMed 26259885Buyon JP. The effects of pregnancy on autoimmune diseases. J Leukoc Biol. 1998 Mar;63(3):281-7. doi: 10.1002/jlb.63.3.281.
PubMed 9500514Chen SJ, Liu YL, Sytwu HK. Immunologic regulation in pregnancy: from mechanism to therapeutic strategy for immunomodulation. Clin Dev Immunol. 2012;2012:258391. doi: 10.1155/2012/258391. Epub 2011 Nov 3.
PubMed 22110530Coe CL. Maternal anxiety during pregnancy influences infant responses to immunization. Brain Behav Immun. 2013 Aug;32:19-20. doi: 10.1016/j.bbi.2013.05.004. Epub 2013 May 21. No abstract available.
PubMed 23707424Coussons-Read ME, Okun ML, Nettles CD. Psychosocial stress increases inflammatory markers and alters cytokine production across pregnancy. Brain Behav Immun. 2007 Mar;21(3):343-50. doi: 10.1016/j.bbi.2006.08.006. Epub 2006 Oct 6.
PubMed 17029703Dayan J, Creveuil C, Herlicoviez M, Herbel C, Baranger E, Savoye C, Thouin A. Role of anxiety and depression in the onset of spontaneous preterm labor. Am J Epidemiol. 2002 Feb 15;155(4):293-301. doi: 10.1093/aje/155.4.293.
PubMed 1183619174 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy and Anxious Thoughts: The Role of the Immune and Endocrine Systems
- ClinicalTrials.gov ID
- NCT03664128
- Acronym / sponsor ID
- IRB00087653
- Conditions
- Perinatal Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Brain & Behavior Research Foundation, National Institute of Mental Health (NIMH)
- Study start
- 24 Jun 2016 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 28 Nov 2022 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
My preliminary data from the Viral Immunity in Pregnancy Study found a strong association in 49 pregnant women between levels of anxiety and of cytokines. When the investigators controlled for clinical confounders, some of those associations disappeared - but there was still a strong correlation between anxiety score and the cytokine interleukin (IL) 6.
Hypothesis: Anxious pregnant women (as determined by a score > 21 on the Perinatal Anxiety Screening Scale (PASS)) will have elevated pro-inflammatory cytokines in pregnancy (at second and third trimesters) and will demonstrate greater continued elevation at 6 weeks and 6 months postpartum when compared to healthy controls. Leukocyte subpopulation analysis in anxious women will show a higher ratio of T-helper 1-type (Th1) to T-helper 2- type (Th2) cells and a greater monocyte activation across the perinatal period than that in healthy controls.
Hypothesis: There will be a negative correlation between allopregnanolone (ALLO) and pro-inflammatory markers (as listed above in primary outcome measure) in pregnancy, and between allopregnanolone (ALLO) in pregnancy and pro-inflammatory markers in the postpartum.
Hypothesis: Women with a pro-inflammatory immune fingerprint and low levels of allopregnanolone (ALLO) as determined by outcomes 1 and 2 will show increased attentional bias to threat, as demonstrated by measurement of autonomic reactivity in response to a validated pregnancy-specific modified Stroop task.
Hypothesis: Anxious pregnant women will find it feasible and acceptable to engage in a mindfulness-based cognitive behavioral therapy intervention for perinatal anxiety.
For each of these, the investigators will compare the outcome between anxious and non-anxious women.
The current study has 2 parts. The initial part, funded by Brain and Behavior Foundation, was designed to collect general information about the immune and endocrine mechanisms of perinatal anxiety and to test following aims:
Aim 1: To determine if obsessional anxiety in pregnancy corresponds to changes in immune functioning.
Aim 2: To determine if symptoms of obsessional anxiety in pregnancy are associated with changes in the levels of progesterone and its metabolites.
Aim 3: To determine feasibility and acceptability of mindfulness-based cognitive behavioral intervention designed to ameliorate prenatal anxiety and the accompanying inflammatory dysregulation.
I next expanded the study to obtain more detailed biological data; There is no intervention in the expansion for this phase.
I plan to recruit a group of 200 pregnant women (100 who screen positive for anxiety and 100 healthy controls). Subjects will answer questionnaires about mood and anxiety symptoms and have participants' blood drawn at four visits across pregnancy and the postpartum; in the second visit, participants will also perform a computer task designed to test how well participants can inhibit responses. A small subset of subjects will enroll in a group mindfulness intervention as well. This study is designed to achieve the following aims:
- To compare the "immune fingerprint" of women with significant perinatal anxiety with that of a cohort of healthy matched controls.
- To determine how perinatal changes in the "immune fingerprint" relate to changes in levels of progesterone metabolites (specifically, allopregnanolone) across pregnancy.
- To identify how changes in the "immune fingerprint" and progesterone metabolites are related to changes in maternal response to threat.
This study is an effort to further characterize the role of the immune system in common psychiatric symptomatology and the likely bidirectional relationship between the immune system and reproductive hormones that may be related to disease flares among a subset of patients. This work could eventually extend to the gene signatures responsible for immune pathways, to epigenetic studies, and/or to brain imaging studies examining differences in brain region function as affected by inflammation. Ultimately, this would allow the investigators to augment the traditional psychopharmacological focus on serotonin modification with new treatment targets, including cytokines, intracellular inflammatory mediators, neurogenesis, or glial cell activation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnant women positive for anxiety | – | Other: Coping with Anxiety through Living Mindfully (CALM) Pregnancy100 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) |
| healthy pregnant controls | – | –100 matched healthy pregnant women. Participants are matched for age, parity, and gestational age at enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant Women with or without mental health history.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coping with Anxiety through Living Mindfully (CALM) PregnancyMindfulness-based Cognitive Behavioral Therapy (CBT) for perinatal anxiety on a subset (8 participants); no intervention for other participants | Other | pregnant women positive for anxiety |
Primary outcome
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.
5 secondary outcomes
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
Heart Rate Variability
Time frame: Second study visit (32-36 weeks gestation)
Electrodermal Activity
Time frame: Second study visit (32-36 weeks gestation)
Feasibility of a mindfulness-based cognitive behavioral therapy intervention as assessed by participant retention number
Time frame: Study visit (22-36 weeks gestation)
Acceptability of a mindfulness-based cognitive behavioral therapy intervention as assessed by a Likert scale
Time frame: Study visit (22-36 weeks gestation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Background: PubMed 17437220Alder J, Fink N, Bitzer J, Hosli I, Holzgreve W. Depression and anxiety during pregnancy: a risk factor for obstetric, fetal and neonatal outcome? A critical review of the literature. J Matern Fetal Neonatal Med. 2007 Mar;20(3):189-209. doi: 10.1080/14767050701209560.
- Background: PubMed 15339755Andersson L, Sundstrom-Poromaa I, Wulff M, Astrom M, Bixo M. Implications of antenatal depression and anxiety for obstetric outcome. Obstet Gynecol. 2004 Sep;104(3):467-76. doi: 10.1097/01.AOG.0000135277.04565.e9.
- Background: PubMed 23496805Ashley V, Honzel N, Larsen J, Justus T, Swick D. Attentional bias for trauma-related words: exaggerated emotional Stroop effect in Afghanistan and Iraq war veterans with PTSD. BMC Psychiatry. 2013 Mar 14;13:86. doi: 10.1186/1471-244X-13-86.
- Background: PubMed 25262048Bar-Shai M, Gott D, Kreinin I, Marmor S. Atypical presentations of pregnancy-specific generalized anxiety disorders in women without a previous psychiatric background. Psychosomatics. 2015 May-Jun;56(3):286-91. doi: 10.1016/j.psym.2013.12.017. Epub 2014 Jan 1. No abstract available.
- Background: PubMed 23978486Backstrom T, Bixo M, Johansson M, Nyberg S, Ossewaarde L, Ragagnin G, Savic I, Stromberg J, Timby E, van Broekhoven F, van Wingen G. Allopregnanolone and mood disorders. Prog Neurobiol. 2014 Feb;113:88-94. doi: 10.1016/j.pneurobio.2013.07.005. Epub 2013 Aug 23.
- Background: PubMed 22112525Baer AN, Witter FR, Petri M. Lupus and pregnancy. Obstet Gynecol Surv. 2011 Oct;66(10):639-53. doi: 10.1097/OGX.0b013e318239e1ee.
- Background: PubMed 23270599Bergink V, Burgerhout KM, Weigelt K, Pop VJ, de Wit H, Drexhage RC, Kushner SA, Drexhage HA. Immune system dysregulation in first-onset postpartum psychosis. Biol Psychiatry. 2013 May 15;73(10):1000-7. doi: 10.1016/j.biopsych.2012.11.006. Epub 2012 Dec 25.
- Background: PubMed 24658404Biggio G, Pisu MG, Biggio F, Serra M. Allopregnanolone modulation of HPA axis function in the adult rat. Psychopharmacology (Berl). 2014 Sep;231(17):3437-44. doi: 10.1007/s00213-014-3521-6.
- Background: PubMed 26259885Brunton PJ. Neuroactive steroids and stress axis regulation: Pregnancy and beyond. J Steroid Biochem Mol Biol. 2016 Jun;160:160-8. doi: 10.1016/j.jsbmb.2015.08.003. Epub 2015 Aug 7.
- Background: PubMed 9500514Buyon JP. The effects of pregnancy on autoimmune diseases. J Leukoc Biol. 1998 Mar;63(3):281-7. doi: 10.1002/jlb.63.3.281.
- Background: PubMed 22110530Chen SJ, Liu YL, Sytwu HK. Immunologic regulation in pregnancy: from mechanism to therapeutic strategy for immunomodulation. Clin Dev Immunol. 2012;2012:258391. doi: 10.1155/2012/258391. Epub 2011 Nov 3.
- Background: PubMed 23707424Coe CL. Maternal anxiety during pregnancy influences infant responses to immunization. Brain Behav Immun. 2013 Aug;32:19-20. doi: 10.1016/j.bbi.2013.05.004. Epub 2013 May 21. No abstract available.
- Hintze, J. PASS 12. 2013. NCSS, LLC. Kaysville, Utah, USALink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Osborne, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perinatal Anxiety, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03664128, which also lists 75 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.