App-Based CBT for Postpartum Depression

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Women and Infants Hospital of Rhode Island

Disqualifiers: Depression, Anxiety, Psychiatric conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new smartphone app called M.Bapp, which uses cognitive behavioral therapy (CBT) techniques to help prevent postpartum depression in new mothers. The app provides interactive modules and daily tasks to support mental health during and after pregnancy. Participants must be pregnant, have a smartphone, and plan to receive postpartum care at a specific clinic. The trial compares M.Bapp to a similar app without the CBT component to determine which is more effective and user-friendly. As an unphased trial, it offers participants the chance to contribute to innovative mental health solutions for new mothers.

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 prior data suggests that this app is safe for postpartum depression treatment?

Research has shown that the Mothers & Babies Program (MB), on which the M.Bapp treatment is based, effectively prevents postpartum depression (PPD) in mothers at high risk. The United States Preventive Services Task Force recommends this program for high-risk pregnant women, highlighting its safety and effectiveness. No specific negative effects have been reported, indicating that the treatment is generally well-tolerated. The M.Bapp is an app version of this program, featuring interactive lessons and daily tasks. Although the app format is new, the core content has a proven safety record, having been successfully used in other formats like in-person sessions or text messages. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for postpartum depression, which often involve medication like antidepressants or traditional in-person therapy sessions, M.Bapp is a smartphone app that brings cognitive behavioral therapy (CBT) directly to new mothers wherever they are. Researchers are excited about M.Bapp because it combines digital parenting education with nine interactive CBT modules, offering a flexible and accessible way to get support. This app not only makes therapy more convenient but also includes daily voluntary assignments that keep users engaged and motivated, potentially improving adherence and outcomes. Plus, users who complete all modules receive a digital certificate, adding an element of achievement to their therapeutic journey.

What evidence suggests that M.Bapp could be an effective treatment for postpartum depression?

Research has shown that the Mothers & Babies Program (MB), on which M.Bapp is based, successfully prevents postpartum depression (PPD) in high-risk mothers without prior depression. The United States Preventive Services Task Force recommends this program for pregnant women at high risk due to its effectiveness. MB has been tested in various formats, including in-person sessions and text messages. In this trial, participants will receive either M.Bapp or an app-based digital parenting education as part of separate treatment arms. M.Bapp is a new version of this program as a smartphone app, featuring interactive lessons based on MB's cognitive behavioral therapy (CBT) approach, which has successfully helped new mothers improve their mental health. Although M.Bapp is a new format, the proven success of the MB program makes it a promising tool for preventing PPD. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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

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)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: M.Bapp Experimental Treatment 1 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 education Active Control 1 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

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials

119

Recruited

59,200+

Published Research Related to This Trial

The Mothers and Babies (MB) 1-on-1 intervention, adapted from a group format, was well-received by clients, with 82% finding it enjoyable and 91.6% reporting they fully understood the material, indicating high acceptability.

Home visitors demonstrated strong implementation fidelity, covering 87.9% of the sessions, suggesting that the adapted intervention is feasible for delivery in a one-on-one setting and warrants further investigation for its effectiveness in reducing depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of an evidence-based postpartum depression intervention: feasibility and acceptability of mothers and babies 1-on-1. Darius Tandon, S., Leis, JA., Ward, EA., et al.[2023]

The MamaLift Plus app was evaluated by 14 participants over a 2-week period and was found to be an acceptable and highly usable tool for managing postpartum depression (PPD).

Participants indicated that the app is practical for weekly use, suggesting it could be a valuable resource for individuals with limited access to traditional mental health care, highlighting the need for further research in digital behavioral health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer acceptance of using a digital technology to manage postpartum depression. Tang, JJ., Malladi, I., Covington, MT., et al.[2022]

A study involving 397 new mothers showed that telephone-based cognitive-behavioral therapy (CBT) significantly reduced depressive symptoms compared to standard care at both 6 weeks and 6 months postpartum.

The intervention was particularly effective for mothers with minor depression, leading to a 23.3% lower rate of postnatal depression at 6 weeks and a 11.4% lower rate at 6 months, demonstrating its efficacy as a treatment option for postpartum depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Telephone-Based Cognitive-Behavioral Therapy on Postnatal Depression: A Randomized Controlled Trial. Ngai, FW., Wong, PW., Leung, KY., et al.[2022]

The study evaluated the feasibility and acceptability of adding SMS text messages to the Mothers and Babies (MB) Course for postpartum depression prevention, involving 28 diverse pregnant women.

Participants found the SMS messages very useful and understandable, with 89% responding to self-monitoring texts, indicating that this digital tool can effectively enhance existing interventions for women at risk for postpartum depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating SMS Text Messages Into a Preventive Intervention for Postpartum Depression Delivered via In-Home Visitation Programs: Feasibility and Acceptability Study. Barrera, AZ., Hamil, J., Tandon, D.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 practice-based training program for postpartum depression significantly improved diagnosis and treatment rates among mothers, with 34.5% of participants showing elevated depression scores, and those in the intervention group more likely to receive appropriate care.

Women in the intervention group reported lower levels of depressive symptoms at both 6 and 12 months postpartum, indicating that structured screening and management can lead to better long-term mental health outcomes for mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TRIPPD: a practice-based network effectiveness study of postpartum depression screening and management. Yawn, BP., Dietrich, AJ., Wollan, P., et al.[2021]

In a study involving 800 women, the web-based intervention 'Be a Mom' was found to be acceptable for both high-risk and low-risk new mothers, although only 27.9% of high-risk and 36.3% of low-risk participants completed the program.

Women in the high-risk group reported finding the program more demanding, suggesting that time constraints may hinder completion rates; thus, developing shorter versions and engagement strategies could improve participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Be a Mom: Patterns of Program Usage and Acceptability Among Women With Low-Risk and High-Risk for Postpartum Depression. Xavier, S., Monteiro, F., Canavarro, MC., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online peer-delivered group cognitive-behavioral therapy for postpartum depression: A randomized controlled trial. Merza, D., Amani, B., Savoy, C., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-Day Workshop Beneficial for Postpartum Depression. Rosenberg, K.[2022]

The Mothers and Babies Program (MB) was found to be acceptable and appropriate for preventing perinatal depression, with no significant differences in acceptability between interventions led by mental health professionals and paraprofessionals, based on a study involving 874 pregnant women.

Participants reported challenges such as group attendance and transportation, but overall, both clients and facilitators enjoyed the program, highlighting its potential as a valuable intervention for pregnant women at risk of depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and appropriateness of a perinatal depression preventive group intervention: a qualitative analysis. Diebold, A., Segovia, M., Johnson, JK., et al.[2020]

Citations

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Protocol for a Cluster-Randomized Controlled Trial Postpartum depression is highly prevalent in low-income women and has significant health and mental health effects on mother and child.

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Effectiveness of a Web-based Prevention Program for ... The original trial was a two-arm pilot prevention of postpartum depression trial comparing the Internet-based course called "Mothers and Babies/Mamás y Bebés" ( ...

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Exploring predictors and prevalence of postpartum depression ... Postpartum depression (PPD) affects around 10% of women, or 1 in 7 women, after giving birth. Undiagnosed PPD was observed among 50% of mothers.

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Mothers and Babies Qatar (MB-Q): A Postpartum ... The study will examine the feasibility and acceptability of the adapted intervention as well as its effectiveness in improving mental health outcomes among ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK519070/

Perinatal Depression - StatPearls - NCBI Bookshelf Perinatal depression is a prevalent and potentially severe mood disorder that affects approximately 1 in 7 people during pregnancy or within the first year ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032721001683

Postpartum depression and infant development up to 24 ... In this population-based large cohort study, PPD as estimated in a national screening program, was associated with delays in early child development.