App-Based CBT for Postpartum Depression

N/A

Recruiting

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 baseline (32-36 weeks' gestation), within one week of delivery, 2 months postpartum, 4 months postpartum, and 6 months postpartum

Awards & highlights

No Placebo-Only Group

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.

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.

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 ~ six months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~six months postpartum

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability

Feasibility

Secondary study objectives

Dyadic Adjustment Scale

Frequency of Mothers and Babies Skills Use

General Anxiety Disorder-7

+3 more

Other study objectives

De novo psychiatric diagnosis

Screening positive on study survey

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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