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Mental Health Screening Education and Referral for Vitamin D Deficiency (PROVIDE Trial)

N/A

Waitlist Available

Led By Eynav Accortt, PhD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Minimum 18 years of age

Female

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 months

Awards & highlights

PROVIDE Trial Summary

This trial is designed to investigate how vitamin D affects inflammation in pregnant women, and whether it's linked to preeclampsia or depression.

Who is the study for?

This trial is for pregnant women aged 18 or older, patients at Cedars Sinai Medical Center in Los Angeles, between 20-40 weeks of gestation (mainly recruited at the start of the third trimester), who prefer English or Spanish.Check my eligibility

What is being tested?

The study investigates vitamin D's anti-inflammatory effects on preeclampsia and depression during pregnancy. It also tests a mental health screening, education, and referral program to prevent postpartum depression.See study design

What are the potential side effects?

Since this trial focuses on screenings and educational programs rather than medication, there are no direct side effects from interventions. However, learning about potential health risks could cause stress or anxiety.

PROVIDE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 18 years old.

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I am female.

PROVIDE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Depression Diagnosis

Depressive symptoms

Secondary outcome measures

Acceptability of Mental Health Program

Anxiety symptoms

Benefits of Mental Health Program

+6 more

PROVIDE Trial Design

1Treatment groups

Experimental Treatment

Group I: Mental Health Screening Education and ReferralExperimental Treatment1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor

500 Previous Clinical Trials

164,699 Total Patients Enrolled

3 Trials studying Vitamin D Deficiency

21 Patients Enrolled for Vitamin D Deficiency

Maternal Mental Health NOWUNKNOWN

1 Previous Clinical Trials

150 Total Patients Enrolled

Eynav Accortt, PhDPrincipal InvestigatorCedars Sinai Medical Center Department of OBGYN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary objective that this medical study aims to achieve?

"The main aim of this investigation, which will span around 5 months, is to assess depressive symptoms. Secondary goals involve evaluating the advantages of the mental health program through Likert-scale surveys during follow-ups, determining the practicality of said program via staff feedback surveys conducted at various intervals, and assessing inflammation levels by measuring serum hs_CRP."

Answered by AI

Are individuals still eligible to participate in this ongoing research?

"Per the details on clinicaltrials.gov, this specific trial is currently not open for participant recruitment. The trial listing was initially published on April 1st, 2017 and last modified on August 2nd, 2021. Nonetheless, it's worth noting that out of the total number of active trials available, there are precisely 1793 studies actively seeking participants."

Answered by AI

Recent research and studies

Nature Reviews NeuroscienceJournal

From Inflammation to Sickness and Depression: When the Immune System Subjugates the Brain

Dantzer, Robert, Jason C. O'Connor, Gregory G. Freund, Rodney W. Johnson, and Keith W. Kelley. 2008. “From Inflammation to Sickness and Depression: When the Immune System Subjugates the Brain”. Nature Reviews Neuroscience. Springer Science and Business Media LLC. doi:10.1038/nrn2297.

Biological PsychiatryJournal

Inflammation and Its Discontents: The Role of Cytokines in the Pathophysiology of Major Depression

Miller, Andrew H., Vladimir Maletic, and Charles L. Raison. 2009. “Inflammation and Its Discontents: The Role of Cytokines in the Pathophysiology of Major Depression”. Biological Psychiatry. Elsevier BV. doi:10.1016/j.biopsych.2008.11.029.

PsychoneuroendocrinologyJournal

Perinatal Depression—the Fourth Inflammatory Morbidity of Pregnancy?

Osborne, Lauren M., and Catherine Monk. 2013. “Perinatal Depression—the Fourth Inflammatory Morbidity of Pregnancy?”. Psychoneuroendocrinology. Elsevier BV. doi:10.1016/j.psyneuen.2013.03.019.

The Journal of Clinical Endocrinology & MetabolismJournal