grant

A Randomized Control Trial of a Culturally Relevant Maternal Wellness App to Improve Black Maternal Mental Health Outcomes

Organization CEDARS-SINAI MEDICAL CENTERLocation LOS ANGELES, UNITED STATESPosted 27 Sept 2022Deadline 31 May 2026
NIHUS FederalResearch GrantFY20230-11 years oldActive Follow-upAddressAdherenceAdvocacyAdvocateAffective DisordersAnxietyAnxiety DisordersAutomobile DrivingBasal Transcription FactorBasal transcription factor genesBiologicalBiological TestingBlackBlack raceBloodBlood Reticuloendothelial SystemC-reactive proteinCOVID-19COVID19CREBCREB1CREB1 geneCV-19CV19CaringCausalityChildChild YouthChildbirthChildren (0-21)ClinicalClinical effectivenessCognitive DiscriminationCommunicationCommunication BarriersCommunitiesCommunity NetworksComplicationControl GroupsCoupledDataDiagnosisDiagnosticDiscriminationDysfunctionEducationEducational aspectsEmotional well beingEtiologyExpression SignatureFeels wellFunctional disorderGene Expression ProfileGeneral Transcription Factor GeneGeneral Transcription FactorsGenesGestationGestational DiabetesGestational Diabetes MellitusGoalsHealthHealthcareHealthy People 2020Immunoglobulin Enhancer-Binding ProteinInflammationInflammatoryInterventionIntervention StrategiesJUNKnowledgeLawsLicensingLightLos AngelesLow Birth Weight InfantMaternal HealthMedicalMental DepressionMental HealthMental Health ServicesMental HygieneMental Hygiene ServicesMental disordersMental health disordersMobile Health AppMobile Health ApplicationMood DisordersMothersMulti-Institutional Clinical TrialMulti-center clinical trialMulti-site clinical trialMulticenter clinical trialMultisite clinical trialNF-kBNF-kappa BNF-kappaBNFKBNormal mental conditionNormal mental stateNormal psycheNuclear Factor kappa BNuclear Transcription Factor NF-kBOutcomeParticipantPatientsPerinatalPeripartumPhotoradiationPhysiciansPhysiologicPhysiologicalPhysiopathologyPopulationPositionPositioning AttributePostpartum PeriodPregnancyPregnancy ComplicationsPregnancy-Induced DiabetesPregnant WomenPrevalencePrimary CareProteins, specific or class, C-reactiveProviderPsyche structurePsychiatric DiseasePsychiatric DisorderPsychological HealthPsychological Well BeingPublic HealthRandomizedRandomized, Controlled TrialsRecommendationReportingResearchResearch ProposalsRiskRisk FactorsRoleSense of well-beingSmall for Gestational Age InfantSourceSpottingsStressStructureSymptomsTechniquesTelemedicineTestingTranscription Factor NF-kBTranscription Factor Proto-OncogeneTranscription factor genesVisitWell in selfWomanWorkactive followupadverse consequenceadverse outcomebehavioral healthbiologicblack femaleblack patientblack womencAMP Response Element-Binding Protein 1causationchild birthclinical careclinician communicationcommunicate to clinicianscommunicate to providerscommunicate with clinicianscommunicate with doctorscommunicate with providerscompare interventioncomparison interventioncomplications during pregnancycorona virus disease 2019coronavirus disease 2019coronavirus disease-19coronavirus infectious disease-19cultural competenceculturally competentdepressiondesigndesigningdifferential expressiondifferentially expresseddisease causationdisparities in racedisparity due to racedisparity in healthdoctor communicationdrivingeffective interventionemotional wellbeingemotional wellnessexpectant motherexpecting motherexperiencefollow upfollow-upfollowed upfollowupgene expression patterngene expression signaturegroup interventionhealth carehealth disparityhealth equityimprovedimproved outcomeinequality due to raceinequity due to raceinsightinterventional strategyjun Oncogenekappa B Enhancer Binding Proteinkidslow birth weightlow birthweightm-Healthm-Health appm-Health applicationmHealthmHealth appmHealth applicationmentalmental health caremental healthcaremental illnessmental well-beingmental wellbeingmental wellnessminority patientmobile healthnovelnuclear factor kappa betaonline careonline health careonline healthcarepathophysiologypatient navigationpatients from minoritypatients of minorityperinatal mental healthperinatal outcomesperinatal periodperinatal phasephysical conditioningphysical healthphysical symptompost-partumpregnancy diabetespregnancy-related complicationspregnant mothersprematureprematurityprenatalpreventpreventingprospectiveprovider communicationpsychiatric illnesspsychoeducationpsychoeducationalpsychological disorderpsychological wellbeingpsychological wellnesspublic health relevancerace based disparityrace based inequalityrace based inequityrace disparityrace related disparityrace related inequalityrace related inequityracial disparityracial inequalityracial inequityracially unequalracismrandomisationrandomizationrandomized control trialrandomly assignedscreeningscreeningsself helpself wellnesssense of wellbeingskillssmall for gestational agesocial rolestandard of carestress bufferingstress managementstress reductionsupport networksystemic inflammationsystemic inflammatory responsetranscription factortranscriptional differencestranscriptional profiletranscriptional signatureunbornvirtualwomen of coloryoungster
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Full Description

Perinatal Mood and Anxiety Disorders (PMADs) encompass a range of mental health disorders that occur during pregnancy and up to one year postpartum. Approximately 13% of women experience PMADs. This rate doubles for those with negative perinatal outcomes (APO) and triples in Black women. Cultural adaptations to improve communication with providers may decrease rates of depression in high-risk patients as well as improve adherence to treatment, insight and alliance.

Stress and worries about experiencing medical consequences are thought to increase systemic inflammation, a mechanism known to drive mental and physical symptoms. Inflammation has been implicated in both PMADs and APO, suggesting a shared underlying etiology. Evidence from our work suggests that inflammation contributes to the pathophysiology of PMADs. The proposed pilot randomized control trial will allow us to build on promising preliminary results and identify whether our culturally relevant mobile Health (mHealth) intervention is effective in improving outcomes among Black pregnant women randomized to the intervention compared to a control group.

The culturally relevant modules include building communication and self-advocacy skills and provide a support network. The primary objective of this research is to provide guidance for clinical care of Black women during the perinatal period, with the goal to improve mental health and physical health outcomes. A secondary goal is to examine novel inflammatory signatures that change as a function of the intervention to reduce PMADs in this population. As inflammation may be diagnostic of PMADs, identification of its role may shed light of potential intervention targets and provide critical knowledge to improve women’s long-term health.

PMAD symptoms will be assessed prospectively in 150 Black pregnant women, half of whom will be randomized to receive the culturally relevant mHealth intervention. We hypothesize that women in the intervention group will have reduced rates of PMADs and APOs, an increase in adherence to mental health treatment and will report increased self-advocacy skills, increased communication with providers, and reduced levels of stress. They will also have improved biological risk indicators including lower circulating C-reactive protein and a transcription profile of differentially expressed inflammatory genes, marked by a decreased activity of inflammatory transcription factors from blood spots. Given the high rates of both PMADs and APOs among Black mothers and the numerous consequences on maternal and child outcomes, it is imperative that we develop and implement effective interventions and test the biological mechanisms that might drive these effects.

This work is interdisciplinary, building on a network of community advocates to implement a novel mHealth intervention informed by real world experiences designed to enhance self-advocacy, reduce stress and prevent negative outcomes.

Grant Number: 5R21MD017396-02
NIH Institute/Center: NIH

Principal Investigator: Eynav Accortt

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