Clinical Trial

Feasibility & Acceptability of App-based Cognitive Behavioral Therapy for Postpartum Depression Prevention

Active, Not Recruiting
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Record status
This record was last updated June 25, 2025 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-04-09; most recent amendment 2025-06-23.
Status change: Recruiting → Active, Not Recruiting 2025-06-23
Status change: Not Yet Recruiting → Recruiting 2024-06-07
Trial Details
NCT Number NCT06365645
Lead Sponsor Women and Infants Hospital of Rhode Island
Conditions Postpartum Depression, Postpartum Anxiety, Stress
Enrollment 90 participants
Start Date 2024-06-07
Primary Completion 2025-09 (estimated)
Study Completion 2025-09 (estimated)
Updated on ClinicalTrials.gov 2025-06-25