<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03018132</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00044664</org_study_id>
    <nct_id>NCT03018132</nct_id>
  </id_info>
  <brief_title>Preeclampsia Research on Vitamin D, Inflammation, &amp; Depression</brief_title>
  <acronym>PROVIDE</acronym>
  <official_title>The PROVIDE Study; Preeclampsia Research on Vitamin D, Inflammation, &amp; Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Maternal Mental Health NOW</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to comprehensively investigate the anti-inflammatory role of vitamin D&#xD;
      in reproductive aged women, and its association with preeclampsia and depression. Findings&#xD;
      will have substantial impact providing new information implicated in the development of&#xD;
      preeclampsia (a condition that may include hypertension, tissue swelling caused by excessive&#xD;
      fluid, and kidney stress) and postpartum depression (after birth).&#xD;
&#xD;
      Additionally, the study is designed to understand how early mental health screening and&#xD;
      evaluation can help pregnant women reduce their risk of developing postpartum depression.&#xD;
      Testing the acceptability and effectiveness of this mental health screening, education and&#xD;
      referral program at Cedars-Sinai Medical Center will provide valuable patient centered&#xD;
      qualitative and quantitative data that can be used in future services planning.&#xD;
&#xD;
      The study will enroll up to 200 pregnant women (in third trimester of pregnancy) in total.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background information&#xD;
&#xD;
      The PROVIDE study tests the hypothesis that low vitamin D levels and increased inflammatory&#xD;
      activity in pregnant women contributes to increased risk of preeclampsia and postpartum&#xD;
      depression (PPD). Preeclampsia is a multisystem disorder of pregnancy commonly characterized&#xD;
      by hypertension that occurs after 20 weeks of gestation in a woman with previously normal&#xD;
      blood pressure accompanied by proteinuria. One pathway thought to lead to preeclampsia is&#xD;
      chronic subclinical inflammation. Likewise, inflammation is elevated in women with major&#xD;
      depressive disorder (MDD) and PPD and may therefore be a common physiological pathway&#xD;
      connecting depression with preeclampsia. In addition, vitamin D deficiency, which is common&#xD;
      in pregnancy and the postpartum period is associated with depressive symptomatology, prenatal&#xD;
      inflammation and adverse birth outcomes, particularly preeclampsia. Research has shown that&#xD;
      vitamin D acts as an anti-inflammatory agent regulating placental function to promote&#xD;
      tolerance of the fetus. Prior work demonstrated that among women with elevated prenatal&#xD;
      inflammation, higher prenatal vitamin D status was associated with lower PPD symptoms. This&#xD;
      research tests the hypothesis that vitamin D deficiency places women with higher levels of&#xD;
      inflammatory cytokines at highest risk for preeclampsia and PPD. Findings will have&#xD;
      substantial impact providing new information about inflammatory mechanisms implicated in the&#xD;
      development of preeclampsia and PPD, and will support future research, such as vitamin D&#xD;
      supplementation to reduce risk for preeclampsia and depression.&#xD;
&#xD;
      The study also seeks a better understanding of several important biopsychosocial consequences&#xD;
      of developing preeclampsia. In pregnancy, 8-13% of women are diagnosed with MDD, which can&#xD;
      lead to postpartum depression (PPD) and adverse birth outcomes, specifically low birth weight&#xD;
      and preeclampsia. Although maternal depression is associated with negative consequences for&#xD;
      the mother, her infant and family, low rates of diagnosis and treatment for perinatal&#xD;
      depression are common in medical settings. Rapid diagnosis and treatment is essential because&#xD;
      the episodes are lengthy and psychosocial symptoms (including anxiety) increase with the&#xD;
      duration of the disorder. Screening is important because it is the first step in the pathway&#xD;
      to treatment. This study tests the acceptability and benefits of a mental health screening,&#xD;
      education and referral program in women with and without preeclampsia. With assistance from a&#xD;
      community partner, Maternal Mental Health-NOW (formerly the L.A. County Perinatal Mental&#xD;
      Health Task Force), findings will provide valuable patient centered qualitative and&#xD;
      quantitative data that can be used in future services planning. This is timely work. In 2015&#xD;
      ACOG recommended that clinicians screen patients at least once during the perinatal period&#xD;
      for depression and anxiety symptoms. Post-traumatic stress symptoms are particularly common&#xD;
      after experiencing an adverse pregnancy outcome, and approximately 9% develop Post-traumatic&#xD;
      stress disorder (PTSD). Increased risk of major depression (40-50%) comorbid with PTSD can&#xD;
      lead to decreased maternal bonding with infant and other long term adverse mental and&#xD;
      physical health repercussions for the mother, child and family. Screening therefore must be&#xD;
      coupled with appropriate follow-up and treatment when indicated, and systems should be in&#xD;
      place to ensure follow-up for diagnosis and treatment. Most recently (2016), the US&#xD;
      Preventive Services Task Force (USPSTF) made perinatal depression screening recommendations,&#xD;
      adding that data are lacking on both the accuracy of screening and the benefits and harms of&#xD;
      treatment in pregnant women. The authors highlight that research is needed to assess barriers&#xD;
      to establishing adequate systems of care and how these barriers can be addressed.&#xD;
&#xD;
      Very little is known from the patient perspective regarding acceptance and benefits of mental&#xD;
      health screening. There is even less understanding of the variation in preferences and need&#xD;
      for these services in women who experience preeclampsia, for whom PPD rates are even higher.&#xD;
      The perinatal period is an opportune time for screening and mental health education due to&#xD;
      the frequency of contact with health care providers, unfortunately rates of diagnosis and&#xD;
      treatment for perinatal depression are low in medical settings. New parents are often highly&#xD;
      motivated to seek help in effecting change for the sake of their offspring and potential&#xD;
      reduction in intergenerational family dysfunction. The perinatal period thus provides&#xD;
      clinicians with a unique opportunity to consider universal psychosocial assessment as part of&#xD;
      mainstream maternity and postnatal care. Early identification and treatment of psychosocial&#xD;
      morbidity are especially important in relation to the functioning of the family unit and the&#xD;
      critical parent-infant relationship with potential to positively impact on the health of the&#xD;
      next generation. Routine depression screening and referral has been supported by RCTs in&#xD;
      Primary Care. RCT work has not been conducted in the perinatal period or in the OB/GYN&#xD;
      setting, however screening, education, and referral programs in obstetric settings have been&#xD;
      well accepted by patients. Overall, mental health care might be most acceptable if provided&#xD;
      as part of routine obstetrical care. Mental health screening and treatment might also be more&#xD;
      beneficial in the subset of women who experience adverse pregnancy complications. Results&#xD;
      from this mental health screening program will allow for early identification and&#xD;
      intervention at a time when women are at highest risk for mental health complications, after&#xD;
      an adverse complication such as preeclampsia.&#xD;
&#xD;
      Objectives and purpose&#xD;
&#xD;
      To our knowledge, no studies have comprehensively investigated the anti-inflammatory role of&#xD;
      vitamin D in depressed reproductive aged women, and its association with adverse pregnancy&#xD;
      outcomes. Findings will have substantial impact providing new information about inflammatory&#xD;
      mechanisms implicated in the development of preeclampsia and PPD, and will support future&#xD;
      intervention research, including vitamin D supplementation, focused on alleviating these&#xD;
      effects. Additionally, testing the acceptability and effectiveness of a new mental health&#xD;
      screening, education and referral program at Cedars-Sinai Medical Center (CSMC) will provide&#xD;
      valuable patient centered qualitative and quantitative data that can be used in future&#xD;
      services planning.&#xD;
&#xD;
      PROVIDE study hypotheses will be tested in a new cohort (N=200) recruited in the third&#xD;
      trimester from CSMC Childbirth and Education classes, the Prenatal Diagnostic Center (PDC),&#xD;
      or in the Maternal-Fetal Care Unit (MFCU, for those diagnosed with Preeclampsia); and&#xD;
      followed through delivery and 2 time points (4 weeks and 3 months) postpartum. A targeted&#xD;
      sampling strategy over a two-year period will result in 100 women who experience preeclampsia&#xD;
      and 100 women who do not.&#xD;
&#xD;
      Specific Aim 1: Determine to what extent prenatal vitamin D deficiency (defined clinically as&#xD;
      serum 25(OH)D &lt; 20 ng/ml48) will be associated with increases in prenatal inflammatory&#xD;
      cytokines (e.g. hs-CRP and Interleukin-6), prenatal depressive symptoms, and preeclampsia.&#xD;
&#xD;
      Hypothesis: Women who experience lower prenatal vitamin D levels will exhibit an increased&#xD;
      likelihood of experiencing prenatal depression, preeclampsia, and postpartum depression.&#xD;
      These effects will be greatest in those with high levels of prenatal inflammatory cytokines.&#xD;
&#xD;
      Specific Aim 2: Determine to what extent women who have preeclampsia will have increases in&#xD;
      postpartum inflammatory cytokines, vitamin D deficiency and PPD.&#xD;
&#xD;
      Hypothesis: Compared to those who do not experience preeclampsia, women with preeclampsia&#xD;
      will have higher postpartum levels of inflammatory cytokines, lower postpartum vitamin D&#xD;
      levels, and increased symptoms of PPD.&#xD;
&#xD;
      Specific Aim 3: Determine to what extent a mental health program that includes screening,&#xD;
      education and referral is acceptable to pregnant women and effective in reducing symptoms of&#xD;
      postpartum depression, anxiety and/or stress following preeclampsia.&#xD;
&#xD;
      Hypothesis: Women in the preeclampsia + depression group will rate the mental health program&#xD;
      as more acceptable and beneficial, and will follow up on referral suggestions more than&#xD;
      depressed-only group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Anticipated">July 2022</completion_date>
  <primary_completion_date type="Actual">July 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>5 months</time_frame>
    <description>as measured by reliable and validated screening tool (EPDS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression Diagnosis</measure>
    <time_frame>5 months</time_frame>
    <description>as measured by diagnostic interview (SCID)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety symptoms</measure>
    <time_frame>5 months</time_frame>
    <description>as measured by the OASIS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-traumatic stress symptoms</measure>
    <time_frame>5 months</time_frame>
    <description>as measured by the IES</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived stress</measure>
    <time_frame>5 months</time_frame>
    <description>as measured by the PSS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability of Mental Health Program</measure>
    <time_frame>5 months</time_frame>
    <description>Results will be based on data from structured (Likert-scale) surveys completed at 4 time points, from the patient perspective</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Benefits of Mental Health Program</measure>
    <time_frame>5 months</time_frame>
    <description>Results will be based on data from the follow-up structured (Likert-scale) survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of Mental Health Program</measure>
    <time_frame>5 months</time_frame>
    <description>The program's feasibility and MMH-Now training will be rated by clinic staff according to structured surveys completed at multiple time points, e.g. pre/post training.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation_IL6</measure>
    <time_frame>5 months</time_frame>
    <description>as measured by serum Interleukin-6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation_CRP</measure>
    <time_frame>5 months</time_frame>
    <description>as measured by serum hs_CRP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin D deficiency</measure>
    <time_frame>5 months</time_frame>
    <description>as measured by serum 25(OH)D levels</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Pre-Eclampsia</condition>
  <condition>Depression</condition>
  <condition>Inflammation</condition>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>Mental Health Screening Education and Referral</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Investigators will prospectively assign all 200 women to this screening, education and referral intervention, without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. The health-related intervention, in this case, is an educational program and related process-of-care changes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>mental health screening, education and referral program</intervention_name>
    <description>I. Psychosocial assessments:&#xD;
Mental health screening for: (1) depressive symptoms with the EPDS, (2) post-traumatic stress symptoms with the IES, (3) for perceived stress with the PSS (4) for anxiety with the OASIS.&#xD;
Exercise, smoking &amp; substance use, sleep and nutrition.&#xD;
II. If women are above cutoff values the SCID will be conducted.&#xD;
III. Education and referral information via Maternal Mental Health NOW:&#xD;
All receive a brochure entitled, Speak Up When You Are Down&#xD;
If above cutoffs, participants will also receive referral information; and will be scheduled for a SCID&#xD;
Trained study staff will review the brochure and show the woman how to use the MMHN online referral system to input their zip code and find preferred maternal mental health practitioners.&#xD;
IV. Follow up with a survey at 3 months postpartum: acceptability of screening, benefit of referral service, and outcome of this referral.</description>
    <arm_group_label>Mental Health Screening Education and Referral</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Minimum 18 years of age&#xD;
&#xD;
          -  Patient at Cedars Sinai Medical Center, Los Angeles, CA&#xD;
&#xD;
          -  Between 20 and 40 weeks gestation (majority recruited at start of 3rd trimester&#xD;
             between 26-32 weeks)&#xD;
&#xD;
          -  English or Spanish language preference&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any diagnosis of psychosis, past or current (evident by either meds taken via medical&#xD;
             intake, or in clinical assessment - SCID)&#xD;
&#xD;
          -  Current substance abuse (evident either via medical intake, or in clinical assessment&#xD;
             - SCID)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eynav Accortt, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars Sinai Medical Center Department of OBGYN</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://directory.maternalmentalhealthnow.org/</url>
    <description>Maternal Mental Health NOW Referral Directory</description>
  </link>
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  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>August 2, 2021</last_update_submitted>
  <last_update_submitted_qc>August 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Eynav Accortt</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>perinatal mental health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Eclampsia</mesh_term>
    <mesh_term>Vitamin D Deficiency</mesh_term>
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03018132
org study id: Pro00044664
nct id: NCT03018132
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is designed to comprehensively investigate the anti-inflammatory role of vitamin D
      in reproductive aged women, and its association with preeclampsia and depression. Findings
      will have substantial impact providing new information implicated in the development of
      preeclampsia (a condition that may include hypertension, tissue swelling caused by excessive
      fluid, and kidney stress) and postpartum depression (after birth).

      Additionally, the study is designed to understand how early mental health screening and
      evaluation can help pregnant women reduce their risk of developing postpartum depression.
      Testing the acceptability and effectiveness of this mental health screening, education and
      referral program at Cedars-Sinai Medical Center will provide valuable patient centered
      qualitative and quantitative data that can be used in future services planning.

      The study will enroll up to 200 pregnant women (in third trimester of pregnancy) in total.
Background information

      The PROVIDE study tests the hypothesis that low vitamin D levels and increased inflammatory
      activity in pregnant women contributes to increased risk of preeclampsia and postpartum
      depression (PPD). Preeclampsia is a multisystem disorder of pregnancy commonly characterized
      by hypertension that occurs after 20 weeks of gestation in a woman with previously normal
      blood pressure accompanied by proteinuria. One pathway thought to lead to preeclampsia is
      chronic subclinical inflammation. Likewise, inflammation is elevated in women with major
      depressive disorder (MDD) and PPD and may therefore be a common physiological pathway
      connecting depression with preeclampsia. In addition, vitamin D deficiency, which is common
      in pregnancy and the postpartum period is associated with depressive symptomatology, prenatal
      inflammation and adverse birth outcomes, particularly preeclampsia. Research has shown that
      vitamin D acts as an anti-inflammatory agent regulating placental function to promote
      tolerance of the fetus. Prior work demonstrated that among women with elevated prenatal
      inflammation, higher prenatal vitamin D status was associated with lower PPD symptoms. This
      research tests the hypothesis that vitamin D deficiency places women with higher levels of
      inflammatory cytokines at highest risk for preeclampsia and PPD. Findings will have
      substantial impact providing new information about inflammatory mechanisms implicated in the
      development of preeclampsia and PPD, and will support future research, such as vitamin D
      supplementation to reduce risk for preeclampsia and depression.

      The study also seeks a better understanding of several important biopsychosocial consequences
      of developing preeclampsia. In pregnancy, 8-13% of women are diagnosed with MDD, which can
      lead to postpartum depression (PPD) and adverse birth outcomes, specifically low birth weight
      and preeclampsia. Although maternal depression is associated with negative consequences for
      the mother, her infant and family, low rates of diagnosis and treatment for perinatal
      depression are common in medical settings. Rapid diagnosis and treatment is essential because
      the episodes are lengthy and psychosocial symptoms (including anxiety) increase with the
      duration of the disorder. Screening is important because it is the first step in the pathway
      to treatment. This study tests the acceptability and benefits of a mental health screening,
      education and referral program in women with and without preeclampsia. With assistance from a
      community partner, Maternal Mental Health-NOW (formerly the L.A. County Perinatal Mental
      Health Task Force), findings will provide valuable patient centered qualitative and
      quantitative data that can be used in future services planning. This is timely work. In 2015
      ACOG recommended that clinicians screen patients at least once during the perinatal period
      for depression and anxiety symptoms. Post-traumatic stress symptoms are particularly common
      after experiencing an adverse pregnancy outcome, and approximately 9% develop Post-traumatic
      stress disorder (PTSD). Increased risk of major depression (40-50%) comorbid with PTSD can
      lead to decreased maternal bonding with infant and other long term adverse mental and
      physical health repercussions for the mother, child and family. Screening therefore must be
      coupled with appropriate follow-up and treatment when indicated, and systems should be in
      place to ensure follow-up for diagnosis and treatment. Most recently (2016), the US
      Preventive Services Task Force (USPSTF) made perinatal depression screening recommendations,
      adding that data are lacking on both the accuracy of screening and the benefits and harms of
      treatment in pregnant women. The authors highlight that research is needed to assess barriers
      to establishing adequate systems of care and how these barriers can be addressed.

      Very little is known from the patient perspective regarding acceptance and benefits of mental
      health screening. There is even less understanding of the variation in preferences and need
      for these services in women who experience preeclampsia, for whom PPD rates are even higher.
      The perinatal period is an opportune time for screening and mental health education due to
      the frequency of contact with health care providers, unfortunately rates of diagnosis and
      treatment for perinatal depression are low in medical settings. New parents are often highly
      motivated to seek help in effecting change for the sake of their offspring and potential
      reduction in intergenerational family dysfunction. The perinatal period thus provides
      clinicians with a unique opportunity to consider universal psychosocial assessment as part of
      mainstream maternity and postnatal care. Early identification and treatment of psychosocial
      morbidity are especially important in relation to the functioning of the family unit and the
      critical parent-infant relationship with potential to positively impact on the health of the
      next generation. Routine depression screening and referral has been supported by RCTs in
      Primary Care. RCT work has not been conducted in the perinatal period or in the OB/GYN
      setting, however screening, education, and referral programs in obstetric settings have been
      well accepted by patients. Overall, mental health care might be most acceptable if provided
      as part of routine obstetrical care. Mental health screening and treatment might also be more
      beneficial in the subset of women who experience adverse pregnancy complications. Results
      from this mental health screening program will allow for early identification and
      intervention at a time when women are at highest risk for mental health complications, after
      an adverse complication such as preeclampsia.

      Objectives and purpose

      To our knowledge, no studies have comprehensively investigated the anti-inflammatory role of
      vitamin D in depressed reproductive aged women, and its association with adverse pregnancy
      outcomes. Findings will have substantial impact providing new information about inflammatory
      mechanisms implicated in the development of preeclampsia and PPD, and will support future
      intervention research, including vitamin D supplementation, focused on alleviating these
      effects. Additionally, testing the acceptability and effectiveness of a new mental health
      screening, education and referral program at Cedars-Sinai Medical Center (CSMC) will provide
      valuable patient centered qualitative and quantitative data that can be used in future
      services planning.

      PROVIDE study hypotheses will be tested in a new cohort (N=200) recruited in the third
      trimester from CSMC Childbirth and Education classes, the Prenatal Diagnostic Center (PDC),
      or in the Maternal-Fetal Care Unit (MFCU, for those diagnosed with Preeclampsia); and
      followed through delivery and 2 time points (4 weeks and 3 months) postpartum. A targeted
      sampling strategy over a two-year period will result in 100 women who experience preeclampsia
      and 100 women who do not.

      Specific Aim 1: Determine to what extent prenatal vitamin D deficiency (defined clinically as
      serum 25(OH)D < 20 ng/ml48) will be associated with increases in prenatal inflammatory
      cytokines (e.g. hs-CRP and Interleukin-6), prenatal depressive symptoms, and preeclampsia.

      Hypothesis: Women who experience lower prenatal vitamin D levels will exhibit an increased
      likelihood of experiencing prenatal depression, preeclampsia, and postpartum depression.
      These effects will be greatest in those with high levels of prenatal inflammatory cytokines.

      Specific Aim 2: Determine to what extent women who have preeclampsia will have increases in
      postpartum inflammatory cytokines, vitamin D deficiency and PPD.

      Hypothesis: Compared to those who do not experience preeclampsia, women with preeclampsia
      will have higher postpartum levels of inflammatory cytokines, lower postpartum vitamin D
      levels, and increased symptoms of PPD.

      Specific Aim 3: Determine to what extent a mental health program that includes screening,
      education and referral is acceptable to pregnant women and effective in reducing symptoms of
      postpartum depression, anxiety and/or stress following preeclampsia.

      Hypothesis: Women in the preeclampsia + depression group will rate the mental health program
      as more acceptable and beneficial, and will follow up on referral suggestions more than
      depressed-only group.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Depressive symptoms
time frame: 5 months
description: as measured by reliable and validated screening tool (EPDS)
measure: Depression Diagnosis
time frame: 5 months
description: as measured by diagnostic interview (SCID)
measure: Anxiety symptoms
time frame: 5 months
description: as measured by the OASIS
measure: Post-traumatic stress symptoms
time frame: 5 months
description: as measured by the IES
measure: Perceived stress
time frame: 5 months
description: as measured by the PSS
measure: Acceptability of Mental Health Program
time frame: 5 months
description: Results will be based on data from structured (Likert-scale) surveys completed at 4 time points, from the patient perspective
measure: Benefits of Mental Health Program
time frame: 5 months
description: Results will be based on data from the follow-up structured (Likert-scale) survey
measure: Feasibility of Mental Health Program
time frame: 5 months
description: The program's feasibility and MMH-Now training will be rated by clinic staff according to structured surveys completed at multiple time points, e.g. pre/post training.
measure: Inflammation_IL6
time frame: 5 months
description: as measured by serum Interleukin-6
measure: Inflammation_CRP
time frame: 5 months
description: as measured by serum hs_CRP
measure: Vitamin D deficiency
time frame: 5 months
description: as measured by serum 25(OH)D levels
arm group label: Mental Health Screening Education and Referral
arm group type: Other
description: Investigators will prospectively assign all 200 women to this screening, education and referral intervention, without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. The health-related intervention, in this case, is an educational program and related process-of-care changes.
intervention type: Other
intervention name: mental health screening, education and referral program
description: I. Psychosocial assessments:
Mental health screening for: (1) depressive symptoms with the EPDS, (2) post-traumatic stress symptoms with the IES, (3) for perceived stress with the PSS (4) for anxiety with the OASIS.
Exercise, smoking & substance use, sleep and nutrition.
II. If women are above cutoff values the SCID will be conducted.
III. Education and referral information via Maternal Mental Health NOW:
All receive a brochure entitled, Speak Up When You Are Down
If above cutoffs, participants will also receive referral information; and will be scheduled for a SCID
Trained study staff will review the brochure and show the woman how to use the MMHN online referral system to input their zip code and find preferred maternal mental health practitioners.
IV. Follow up with a survey at 3 months postpartum: acceptability of screening, benefit of referral service, and outcome of this referral.
arm group label: Mental Health Screening Education and Referral
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Eynav Accortt, PhD
role: Principal Investigator
affiliation: Cedars Sinai Medical Center Department of OBGYN
facility: 
country: United States
url: http://directory.maternalmentalhealthnow.org/
description: Maternal Mental Health NOW Referral Directory
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responsible party type: Principal Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Eynav Accortt
investigator title: Assistant Professor
mesh term: Pre-Eclampsia
mesh term: Eclampsia
mesh term: Vitamin D Deficiency
mesh term: Inflammation
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No