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NCT06365645 · ClinicalTrials.gov registry record · NA
Feasibility & Acceptability of App-based Cognitive Behavioral Therapy for Postpartum Depression Prevention
A NA study of Stress and Postpartum Depression, sponsored by Women and Infants Hospital of Rhode Island.
- Active
- Registry status
- NA
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT06365645: Active NA study of Stress and Postpartum Depression, sponsored by Women and Infants Hospital of Rhode Island.
NCT06365645 is a NA study of Stress and Postpartum Depression that is active but no longer recruiting, run by Women and Infants Hospital of Rhode Island. The registered enrollment target is 90 participants, below the 786-participant average among 152 other Stress trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06365645, a NA study of Stress and Postpartum Depression, is active but no longer recruiting, sponsored by Women and Infants Hospital of Rhode Island.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
50% of those who are eligible based on prescreening and who are approached to participate consent to participate and 80% of those randomized to M.Bapp view at least 5 of the 10 modules
Conditions Studied
Interventions
- BEHAVIORAL M.Bapp
- BEHAVIORAL App-based parenting education
Study Locations (1)
Rhode Island
- Women & Infants Hospital of Rhode Island - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2024-06-07 |
| Est. Completion | 2025-09 |
| Phase | NA |
What the registry record for NCT06365645 still lists
NCT06365645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 786-participant average among 152 other Stress trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Stress appearing as the primary indexed condition, and to 2 interventions - of which M.Bapp is the first listed.
NCT06365645 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT06365645 about?
NCT06365645 is a clinical study titled "Feasibility & Acceptability of App-based Cognitive Behavioral Therapy for Postpartum Depression Prevention". 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-ri...
What is the current status of trial NCT06365645?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 90 participants. The study started on 2024-06-07. Estimated completion is 2025-09.
What conditions does trial NCT06365645 study?
This clinical trial studies the following conditions: Stress, Postpartum Depression, Postpartum Anxiety.
What interventions are being tested in trial NCT06365645?
The interventions under investigation include: M.Bapp (BEHAVIORAL), App-based parenting education (BEHAVIORAL).
Who is sponsoring clinical trial NCT06365645?
This trial is sponsored by Women and Infants Hospital of Rhode Island, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06365645 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06365645's enrollment target sits among peer trials
90 71st of 152 higher than 81 of 152 other Stress trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stress trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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