App-Based CBT for Postpartum Depression

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Women and Infants Hospital of Rhode Island

Disqualifiers: Depression, Anxiety, Psychiatric conditions, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 3 9 10}

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

I speak English or Spanish.

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)

Trial 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 (Behavioural Intervention)

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

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Women & Infants Hospital of Rhode Island Providence, RI

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

One-Day Workshop Beneficial for Postpartum Depression. [2022] According to this study: An online one-day workshop based on cognitive behavioral therapy, in addition to treatment as usual, improves postpartum depression, anxiety, social support, the mother-infant relationship, and infant temperament.Online one-day workshops for postpartum depression could be an efficient means of improving treatment access and reducing symptoms.

2. Ireland pubmed.ncbi.nlm.nih.gov

Effectiveness of an app-based cognitive behavioral therapy program for postpartum depression in primary care: A randomized controlled trial. [2020] The objective of this study was to examine the effect of mobile phone applications (App) based cognitive behavioral therapy (CBT) on postpartum depression.

3. United States pubmed.ncbi.nlm.nih.gov

Online peer-delivered group cognitive-behavioral therapy for postpartum depression: A randomized controlled trial. [2023] Postpartum depression (PPD) affects up to one in five mothers and birthing parents, yet just 10% receive evidence-based care. This randomized controlled trial aimed to determine if a synchronous online 9-week group cognitive-behavioral therapy (CBT) intervention delivered by mothers who have recovered from postpartum depression (i.e., peers) could effectively improve PPD and its comorbidities.

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Telephone-Based Cognitive-Behavioral Therapy on Postnatal Depression: A Randomized Controlled Trial. [2022] Cognitive-behavioral therapy (CBT) is one of the most effective interventions for postnatal depression. However, few studies have evaluated the effect of CBT delivered via telephone for newborn mothers. The purpose of this study was to evaluate the efficacy of telephone-based CBT for postnatal depression at 6 weeks and 6 months postpartum.

5. United States pubmed.ncbi.nlm.nih.gov

TRIPPD: a practice-based network effectiveness study of postpartum depression screening and management. [2021] Postpartum depression is common but inadequately recognized and undertreated. Continuing depressive symptoms are associated with adverse outcomes for the woman, her infant, and family. We wanted to determine the effect of a practice-based training program for screening, diagnosis, and management of depression in postpartum mothers.

6. England pubmed.ncbi.nlm.nih.gov

Adaptation of an evidence-based postpartum depression intervention: feasibility and acceptability of mothers and babies 1-on-1. [2023] Mothers and Babies (MB) is a cognitive-behavioral intervention with demonstrated efficacy in reducing depressive symptoms and preventing depressive episodes among perinatal women when delivered in a group format by mental health professionals. Study aims were to describe the adaptation of MB into a 1-on-1 modality (MB 1-on-1) and provide data on the adapted intervention's acceptability and feasibility.

7. Canada 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. [2022] The Mothers and Babies (MB) Course is recognized by the US Preventive Services Task Force as an evidence-based preventive intervention for postpartum depression (PPD) that should be recommended to pregnant women at risk for PPD.

8. England pubmed.ncbi.nlm.nih.gov

Acceptability and appropriateness of a perinatal depression preventive group intervention: a qualitative analysis. [2020] Perinatal depression is a prevalent public health concern. Although preventive interventions exist, there is limited literature on the acceptability and appropriateness of these interventions, especially those delivered by paraprofessionals. The Mothers and Babies Program (MB) is a group-based perinatal depression preventive intervention delivered prenatally. A cluster-randomized controlled trial examined the acceptability, appropriateness, and effectiveness of MB delivered by mental health professionals compared to paraprofessional staff from home visiting programs.

9. Switzerland 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. [2022] Be a Mom is a self-guided web-based intervention developed to prevent postpartum depression (PPD) symptoms and to promote maternal wellbeing, respectively among high and low-risk new mothers. This study aims to examine and compare (1) Be a Mom's patterns of usage and (2) Be a Mom's acceptability among women presenting high and low risk for PPD.

10. Switzerland pubmed.ncbi.nlm.nih.gov

Consumer acceptance of using a digital technology to manage postpartum depression. [2022] The goal of the study was to evaluate the end user experience using the MamaLift Plus app for 2 weeks to support the treatment of their postpartum depression (PPD). A total of 14 participants completed the study and their experiences are reported in this publication. Participants reported that MamaLift Plus is an acceptable, highly usable, and practical mobile tool to use weekly for the management of their PPD. More research is warranted to evaluate the benefit of digital behavior health interventions, especially in patient populations where mental health care may be limited or harder to access by patients.