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Postpartum DepressionNCT06365645

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

A study testing M.Bapp and App-based parenting education in people with Postpartum Depression and Postpartum Anxiety, run by Women and Infants Hospital of Rhode Island at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 60 years, women only
Conditions the study is for
Postpartum Depression, Postpartum Anxiety, Stress
What is being tested?
M.Bapp and App-based parenting education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
7 Jun 2024to 14 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • English- or Spanish-speaking
  • maternal age >18 years old
  • smartphone ownership
  • receiving prenatal care from a resident or nurse-practitioner/midwifery clinic at the Obstetric and Gynecologic Care Center at WIH
  • plan to receive postpartum care at the OGCC,
  • gestational age ≥32 weeks'.

Who cannot join

  • Active diagnosis or history within five years of depression, anxiety, or other psychiatric condition, as documented in the electronic medical record
  • Endorsing active suicidality on intake survey or screening positive on EPDS (≥10) or Patient Health Questionnaire (PHQ)-9 (≥10) or GAD-7 (≥8)
  • prisoners
  • inability to consent.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

Other trials in United States

About this study

Official title: Examining the Feasibility and Acceptability of a Novel App-based Cognitive Behavioral Therapy Intervention for Preventing Postpartum Depression

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.

Read the detailed description

Overall, 10-15% of women are diagnosed with postpartum depression (PPD). Though the most significant risk factor for PPD is a history of depression or prior PPD, rates of PPD are as high as 25% among women without prior depression or PPD but with personal risk factors such as reporting little social support or food insecurity during pregnancy and structural factors such as being unmarried. There are profound maternal and pediatric consequences of postpartum mental illness: untreated PPD is associated with maternal morbidity9-11 and impaired child cognitive development. As such, the American College of Obstetricians \& Gynecologists recommends screening all postpartum women for PPD.

There are, however, several structural barriers to the implementation of this recommendation. First, to be screened for PPD, women must attend postpartum visits, and <60% of women do so. Barriers such as lack of childcare or transportation reduce postpartum visit attendance and disproportionately affect low-income women. Second, pregnancy-related health insurance ends at 60 days postpartum, but PPD can persist for months after delivery, leaving low-income women without subsidized access to screening or treatment. Third, unlike those with known psychiatric illness, many pregnant women without prior mental illness do not receive antenatal mental health screening (unless via universal screening) leading to delayed recognition of and diagnosis of depressive symptoms. Tools to overcome these barriers are sorely needed, particularly for those with the least access who currently fall through the cracks.

Therapy preventing PPD delivered via smartphone applications (apps) may be such a tool. The USPSTF concluded that Cognitive Behavioral Therapy (CBT) - which teaches coping skills to modify maladaptive conditions, behaviors, and physiological responses24, 25 - reduces rates of PPD by 49%. The USPSTF highlighted the Mothers and Babies (MB) CBT program for reducing rates of PPD by 53% among low-income women of color. MB was originally designed as a preventive in-person therapy for low-income English- and Spanish-speaking women without psychiatric illness and contains one parenting education module and multiple CBT modules. MB has started to become a digital health intervention: online MB has been shown to be feasible, and text-message-base MB has been examined in one small study. However, to our knowledge, no studies of app-based MB exist. Online or text-message MB may increase access, but participation with an app would likely be higher for several reasons. Individuals are more likely to have smartphones than internet access: 96% of those aged 18-29 years own smartphones. Additionally, apps provide two advantages compared to other digital health programs: (1) App-based content is accessible without cellular or internet service, (2) Apps serve as just-in-time adaptive interventions,35-37 delivering support tailored to individual behaviors. Thus, app-based MB may decrease PPD while overcoming barriers to care.

Over the last two years, this NIH-funded study has utilized evidence-based user-centered digital intervention design techniques and qualitative research methodology to adapt the MB curriculum into a novel smartphone application, M.Bapp. Similar to MB, M.Bapp contains one parenting education module and multiple CBT-based modules.We now propose a pilot randomized control trial to examine the feasibility, acceptability, and preliminary estimates of effects of the full MB program via M.Bapp (intervention) when compared to app-based digital parenting education (an attention control group). Our long-term goal is to use M.Bapp to prevent PPD among perinatal women at high-risk for the condition due to those with structural or personal risk factors.

Being tested
M.Bapp, App-based parenting education
Keywords
perinatal mental health, digital health, postpartum depression, postpartum anxiety, smartphone application (app)
Medical subject headings
Depression, Postpartum, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • M.BappBehavioural

    Please see experimental group description.

  • App-based parenting educationBehavioural

    Please see active comparator group description.

Study groups in NCT06365645
Study groupRoleWhat they receive
App-based digital parenting educationActive comparatorApp-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.
Receives: Behavioral: App-based parenting education
M.BappExperimentalM.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.
Receives: Behavioral: M.Bapp

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility

    50% of those who are eligible based on prescreening and who are approached to participate consent to participate and 80% of those randomized to M.Bapp view at least 5 of the 10 modules

    Measured: Randomization and six months postpartum

  2. Acceptability

    Scoring at least 80% on two well-validated scales: the System Usability Scale (focusing on perceived usability of technology) and the Client Satisfaction Questionnaire (focusing on satisfaction with mental health therapy). These surveys will also contain questions covering additional themes about participant experience with the study intervention (either M.Bapp or app-based parenting education)-(1) helpfulness; (2) satisfaction; and (3) ease of interface with technical aspects of the program.

    Measured: Six months postpartum

Secondary outcomes (6)
  1. Inventory for Depression Scale

    30-item Score from 0 to 84. Screen positive: score ≥26 or suicidal ideation

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

  2. General Anxiety Disorder-7

    7-item self-report on anxiety symptoms

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

  3. Perceived Stress-Scale 4

    4-item self-report on stress symptoms

    Measured: Baseline (32-36 weeks' gestation), 2 months postpartum, and 6 months postpartum

  4. Dyadic Adjustment Scale

    7-item survey measuring relationship satisfaction, decision-making and cohesion

    Measured: Baseline (32-36 weeks' gestation), 2 months postpartum, and 6 months postpartum

  5. UCLA Loneliness Scale

    20-item survey measuring loneliness

    Measured: Baseline (32-36 weeks' gestation), 2 months postpartum, and 6 months postpartum

  6. Frequency of Mothers and Babies Skills Use

    10-item survey created by MB to evaluate perceived helpfulness of intervention

    Measured: 6 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2024
  2. Study start7 Jun 2024
  3. Primary completion14 Jun 2025
  4. Study completion14 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06365645
Sponsor's protocol ID
2138752
Status last verified
Aug 2026
First submitted
9 Apr 2024
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data from this small pilot will not be made available to other researchers

Questions about this trial

What is this clinical trial studying?

A study testing M.Bapp and App-based parenting education in people with Postpartum Depression and Postpartum Anxiety, run by Women and Infants Hospital of Rhode Island at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility (time frame: Randomization and six months postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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Clinical Trial NCT06365645 | AzTrials