90 Participants Needed

App-Based CBT for Postpartum Depression

Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Women and Infants Hospital of Rhode Island
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment M.Bapp, Mothers & Babies Program, M.Bapp, MB for postpartum depression?

Research shows that cognitive behavioral therapy (CBT), whether delivered through an app, online workshops, or by phone, can effectively reduce symptoms of postpartum depression. These studies suggest that app-based CBT, like the M.Bapp program, could be a helpful treatment option for new mothers experiencing postpartum depression.12345

Is app-based CBT for postpartum depression safe for humans?

The Mothers and Babies (MB) program, which includes app-based cognitive-behavioral therapy (CBT), has been recognized as a safe and acceptable intervention for postpartum depression. It has been recommended by the US Preventive Services Task Force for pregnant women at risk for postpartum depression.678910

How is the M.Bapp treatment for postpartum depression different from other treatments?

M.Bapp is unique because it uses an app-based approach to deliver cognitive behavioral therapy (CBT), making it more accessible and convenient for new mothers who may have limited access to traditional mental health care. This digital format allows for flexible, self-paced engagement, which can be particularly beneficial for managing postpartum depression.123910

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I am over 18 years old.
Gestational age ≥32 weeks
Smartphone ownership
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Exclusion Criteria

I am unable to give consent by myself.
Prisoners
Endorsing active suicidality on intake survey or screening positive on EPDS (≥10) or Patient Health Questionnaire (PHQ)-9 (≥10) or GAD-7 (≥8)
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Treatment

Participants are randomized to either the M.Bapp intervention or the app-based digital parenting education control group. The treatment involves using the assigned app for cognitive behavioral therapy or parenting education.

6 months postpartum
App-based interaction

Follow-up

Participants are monitored for acceptability, feasibility, and various psychological outcomes such as stress, anxiety, and depression.

6 months postpartum
Surveys at baseline, 2 months, 4 months, and 6 months postpartum

Treatment Details

Interventions

  • M.Bapp
Trial Overview 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.
Participant Groups
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.

M.Bapp is already approved in United States for the following indications:

🇺🇸
Approved in United States as M.Bapp for:
  • Prevention of postpartum depression

Find a Clinic Near You

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials
119
Recruited
59,200+

Findings from Research

A one-day online workshop utilizing cognitive behavioral therapy significantly improved symptoms of postpartum depression and anxiety, as well as enhancing social support and the mother-infant relationship.
This approach offers an efficient way to increase access to treatment for postpartum depression, suggesting it could be a valuable addition to standard care.
One-Day Workshop Beneficial for Postpartum Depression.Rosenberg, K.[2022]
A study involving 75 women showed that mobile phone app-based cognitive behavioral therapy (CBT) significantly reduced postpartum depression symptoms, as measured by the Edinburgh Postnatal Depression Scale (EPDS), with scores dropping from 15.05 in the control group to 8.18 in the intervention group after 2 months.
The results indicate that mobile app-based CBT is an effective intervention for improving mental health outcomes in postpartum women, highlighting its potential as a convenient and accessible treatment option.
Effectiveness of an app-based cognitive behavioral therapy program for postpartum depression in primary care: A randomized controlled trial.Jannati, N., Mazhari, S., Ahmadian, L., et al.[2020]
A randomized controlled trial with 183 participants showed that a 9-week online group cognitive-behavioral therapy (CBT) led by peers significantly reduced postpartum depression (PPD) and anxiety symptoms, with improvements lasting for at least 3 months after the intervention.
The study also found enhancements in maternal social support and reductions in infant-focused anxiety and negative emotionality, suggesting that this peer-delivered approach could effectively increase access to treatment for PPD and benefit families overall.
Online peer-delivered group cognitive-behavioral therapy for postpartum depression: A randomized controlled trial.Merza, D., Amani, B., Savoy, C., et al.[2023]

References

One-Day Workshop Beneficial for Postpartum Depression. [2022]
Effectiveness of an app-based cognitive behavioral therapy program for postpartum depression in primary care: A randomized controlled trial. [2020]
Online peer-delivered group cognitive-behavioral therapy for postpartum depression: A randomized controlled trial. [2023]
The Effect of Telephone-Based Cognitive-Behavioral Therapy on Postnatal Depression: A Randomized Controlled Trial. [2022]
TRIPPD: a practice-based network effectiveness study of postpartum depression screening and management. [2021]
Adaptation of an evidence-based postpartum depression intervention: feasibility and acceptability of mothers and babies 1-on-1. [2023]
Integrating SMS Text Messages Into a Preventive Intervention for Postpartum Depression Delivered via In-Home Visitation Programs: Feasibility and Acceptability Study. [2022]
Acceptability and appropriateness of a perinatal depression preventive group intervention: a qualitative analysis. [2020]
Be a Mom: Patterns of Program Usage and Acceptability Among Women With Low-Risk and High-Risk for Postpartum Depression. [2022]
Consumer acceptance of using a digital technology to manage postpartum depression. [2022]
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