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Preeclampsia Research on Vitamin D, Inflammation, & Depression (PROVIDE)

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ClinicalTrials.gov Identifier: NCT03018132
Recruitment Status : Not yet recruiting
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
Sponsor:
Collaborator:
Maternal Mental Health NOW
Information provided by (Responsible Party):
Eynav Accortt, Cedars-Sinai Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pre-Eclampsia Depression Inflammation Vitamin D Deficiency Other: mental health screening, education and referral program Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The PROVIDE Study; Preeclampsia Research on Vitamin D, Inflammation, & Depression
Study Start Date : January 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Mental Health Screening Education and Referral
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.
Other: mental health screening, education and referral program

I. Psychosocial assessments:

  1. 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.
  2. 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:

  1. All receive a brochure entitled, Speak Up When You Are Down
  2. If above cutoffs, participants will also receive referral information; and will be scheduled for a SCID
  3. 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.





Primary Outcome Measures :
  1. Depressive symptoms [ Time Frame: 5 months ]
    as measured by reliable and validated screening tool (EPDS)

  2. Depression Diagnosis [ Time Frame: 5 months ]
    as measured by diagnostic interview (SCID)


Secondary Outcome Measures :
  1. Anxiety symptoms [ Time Frame: 5 months ]
    as measured by the OASIS

  2. Post-traumatic stress symptoms [ Time Frame: 5 months ]
    as measured by the IES

  3. Perceived stress [ Time Frame: 5 months ]
    as measured by the PSS

  4. Acceptability of Mental Health Program [ Time Frame: 5 months ]
    Results will be based on data from structured (Likert-scale) surveys completed at 4 time points, from the patient perspective

  5. Benefits of Mental Health Program [ Time Frame: 5 months ]
    Results will be based on data from the follow-up structured (Likert-scale) survey

  6. Feasibility of Mental Health Program [ Time Frame: 5 months ]
    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.

  7. Inflammation_IL6 [ Time Frame: 5 months ]
    as measured by serum Interleukin-6

  8. Inflammation_CRP [ Time Frame: 5 months ]
    as measured by serum hs_CRP

  9. Vitamin D deficiency [ Time Frame: 5 months ]
    as measured by serum 25(OH)D levels



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • Minimum 18 years of age
  • Patient at Cedars Sinai Medical Center, Los Angeles, CA
  • Between 20 and 40 weeks gestation (majority recruited at start of 3rd trimester between 26-32 weeks)
  • English or Spanish language preference

Exclusion Criteria:

  • Any diagnosis of psychosis, past or current (evident by either meds taken via medical intake, or in clinical assessment - SCID)
  • Current substance abuse (evident either via medical intake, or in clinical assessment - SCID)

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): NCT03018132


Contacts
Contact: Eynav E Accortt, PhD 310-423-8744 eynav.accortt@cshs.org
Contact: Sarah Kilpatrick, MD, PhD 310-423-7433 sarah.kilpatrick@cshs.org

Sponsors and Collaborators
Cedars-Sinai Medical Center
Maternal Mental Health NOW
Investigators
Principal Investigator: Eynav Accortt, PhD Cedars Sinai Medical Center Department of OBGYN

Additional Information:
Publications:
Miller DA. Hypertension in pregnancy. Diagnosis and treatment obstetrics and gynecology 2003;10:318.
Arora CP & Hobel, C. Vitamin D - a novel role in pregnancy. Bioploymers and Cell. 2010;26(97):104.
Cohen S. Perceived stress in a probability sample of the United States. Sage Publications, Inc. 1988:31-67.

Responsible Party: Eynav Accortt, Assistant Professor, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03018132     History of Changes
Other Study ID Numbers: Pro00044664
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Eynav Accortt, Cedars-Sinai Medical Center:
perinatal mental health

Additional relevant MeSH terms:
Depression
Depressive Disorder
Inflammation
Pre-Eclampsia
Vitamin D Deficiency
Eclampsia
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pathologic Processes
Hypertension, Pregnancy-Induced
Pregnancy Complications
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents