protocolSection identificationModule nctId: NCT06365645, orgStudyIdInfo id: 2138752, briefTitle: Feasibility & Acceptability of App-based Cognitive Behavioral Therapy for Postpartum Depression Prevention, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Women and Infants Hospital of Rhode Island, class: OTHER, descriptionModule briefSummary: Postpartum depression (PPD) affects up 10-15% of mothers overall, but the rate of PPD can be as high as 25% among mothers with personal or obstetric risk factors. The Mothers \& Babies Program (MB) is a cognitive behavioral therapy (CBT)-based program that has been shown to prevent PPD among high-risk mothers without a prior history of depression. MB has been so consistently effective that the United States Preventive Services Task Force recommends this program be given to high-risk pregnant patients. Originally designed to be given in-person and via groups, MB has been adapted to be given in person one-on-one in clinic or at home and via text message. However, MB has yet to be adapted to a smartphone application (app). Via evidence-based qualitative research and end-user centered design, MB has been adapted to a novel app, M.Bapp. This study aims to examine the feasibility and acceptability of M.Bapp as a study intervention for perinatal patients as well as provide preliminary estimates of effect for the intervention., conditionsModule conditions: Postpartum Depression, conditions: Postpartum Anxiety, conditions: Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: Participants who consent will be unaware of the existence of another version of M.Bapp. Obstetric care providers will be aware of participant's enrollment in this trial but not of the study group and will be encouraged to provide standardized care. The research team and outcomes assessors will be blindd to the randomization group., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: M.Bapp, interventions name: App-based parenting education, outcomesModule primaryOutcomes measure: Feasibility, primaryOutcomes measure: Acceptability, secondaryOutcomes measure: Edinburgh Postnatal Depression Scale, secondaryOutcomes measure: General Anxiety Disorder-7, secondaryOutcomes measure: Perceived Stress-Scale 4, secondaryOutcomes measure: Dyadic Adjustment Scale, secondaryOutcomes measure: UCLA Loneliness Scale, secondaryOutcomes measure: Frequency of Mothers and Babies Skills Use, otherOutcomes measure: De novo psychiatric diagnosis, otherOutcomes measure: Screening positive on study survey, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Women & Infants Hospital of Rhode Island, city: Providence, state: Rhode Island, zip: 02905, country: United States, geoPoint lat: 41.82399, lon: -71.41283, hasResults: False