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Behavioural Intervention

M.Bapp for Postpartum Anxiety

N/A

Waitlist Available

Research Sponsored by Women and Infants Hospital of Rhode Island

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within one week of delivery, 2 months postpartum, 4 months postpartum, and 6 months postpartum

Awards & highlights

Study Summary

This trial is testing a new smartphone app called M.Bapp, based on the Mothers & Babies Program, to help prevent postpartum depression in high-risk mothers. The app is being studied to see

Who is the study for?

This trial is for new mothers who may be at high risk of postpartum depression, which can affect up to 25% of mothers with certain risk factors. The study is open to those without a prior history of depression and aims to help prevent PPD through an app-based program.Check my eligibility

What is being tested?

The trial tests the feasibility and acceptability of M.Bapp, an app that delivers cognitive behavioral therapy (CBT) based education for preventing postpartum depression. It's adapted from the Mothers & Babies Program recommended by US Preventive Services Task Force.See study design

What are the potential side effects?

Since this intervention involves educational content delivered via an app, there are no direct medical side effects like you would expect with medication. However, users might experience discomfort or stress related to engaging with the material.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization and six months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization and six months postpartum

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

Treatment Details

Study Objectives

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

Primary outcome measures

Acceptability

Feasibility

Secondary outcome measures

Dyadic Adjustment Scale

Edinburgh Postnatal Depression Scale

Frequency of Mothers and Babies Skills Use

+3 more

Other outcome measures

De novo psychiatric diagnosis

Screening positive on study survey

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: M.BappExperimental Treatment1 Intervention

M.Bapp contains the same app-based digital parenting education provided to the active comparator group as well as 9 additional interactive modules based on the MB cognitive behavioral therapy curriculum. M.Bapp contains interactive features and EMA-based voluntary daily assignments that provide the opportunity to receive additional final reimbursement. Those who complete all modules will receive a digital certificate of completion.

Group II: App-based digital parenting educationActive Control1 Intervention

App-based digital parenting education will be delivered through a smartphone app with similar features as M.Bapp, but the content delivered through this attention-matched control app will not contain any CBT modules or psychoeducation.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Women and Infants Hospital of Rhode IslandLead Sponsor

109 Previous Clinical Trials

38,540 Total Patients Enrolled

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 of conducting this clinical trial?

"This clinical trial aims to assess feasibility within a six-month postpartum period. Secondary measurements involve the Edinburgh Postnatal Depression Scale, which rates from 0 to 30; individuals scoring ≥10 or expressing suicidal thoughts screen positive. Also evaluated are loneliness using the UCLA Loneliness Scale, and perceived usefulness of interventions through the Frequency of Mothers and Babies Skills Use survey with 10 items developed by MB."

Answered by AI

Can individuals younger than 20 years old participate in this medical study?

"Eligible candidates for this research opportunity are limited to individuals aged between 18 and 60. It is noteworthy that there are a total of 257 clinical trials catering to those under 18 years old, as well as 1143 studies focused on participants above the age of 65."

Answered by AI

Are there any available positions for participants in this research study?

"As per clinicaltrials.gov, the ongoing trial is not currently accepting participants. This specific study was initially listed on May 1st, 2024 and last modified on April 9th, 2024. Despite this particular trial being closed for recruitment presently, there are approximately 1572 other active trials seeking eligible candidates at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Adam Lewkowitz 2024. "Feasibility & Acceptability of App-based Cognitive Behavioral Therapy for Postpartum Depression Prevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06365645.