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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Postpartum Depression, Postpartum Anxiety, Stress
- 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 group | Role | What they receive |
|---|---|---|
| App-based digital parenting education | Active comparator | 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. Receives: Behavioral: App-based parenting education |
| M.Bapp | Experimental | 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. Receives: Behavioral: M.Bapp |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
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
Perceived Stress-Scale 4
4-item self-report on stress symptoms
Measured: Baseline (32-36 weeks' gestation), 2 months postpartum, and 6 months postpartum
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
UCLA Loneliness Scale
20-item survey measuring loneliness
Measured: Baseline (32-36 weeks' gestation), 2 months postpartum, and 6 months postpartum
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.
- First posted15 Apr 2024
- Study start7 Jun 2024
- Primary completion14 Jun 2025
- Study completion14 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Lewkowitz, Women and Infants Hospital of Rhode Island
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Feasibility and Acceptability of a Novel App-based Cognitive Behavioral Therapy Intervention for Preventing Postpartum Depression
- ClinicalTrials.gov ID
- NCT06365645
- Acronym / sponsor ID
- 2138752
- Conditions
- Postpartum Depression, Postpartum Anxiety, Stress
- Keywords
- perinatal mental health, digital health, postpartum depression, postpartum anxiety, smartphone application (app)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 14 Jun 2025 (actual)
- Study completion
- 14 Jun 2025 (actual)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App-based digital parenting education | Active comparator | Behavioral: App-based parenting educationApp-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 | Experimental | Behavioral: M.BappM.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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M.BappPlease see experimental group description. | Behavioural | M.Bapp |
| App-based parenting educationPlease see active comparator group description. | Behavioural | App-based digital parenting education |
Primary outcome
Feasibility
Time frame: Randomization and six months postpartum
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
Acceptability
Time frame: Six months postpartum
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.
6 secondary outcomes
Inventory for Depression Scale
Time frame: Baseline (32-36 weeks' gestation), within one week of delivery, 2 months postpartum, 4 months postpartum, and 6 months postpartum
General Anxiety Disorder-7
Time frame: Baseline (32-36 weeks' gestation), within one week of delivery, 2 months postpartum, 4 months postpartum, and 6 months postpartum
Perceived Stress-Scale 4
Time frame: Baseline (32-36 weeks' gestation), 2 months postpartum, and 6 months postpartum
Dyadic Adjustment Scale
Time frame: Baseline (32-36 weeks' gestation), 2 months postpartum, and 6 months postpartum
UCLA Loneliness Scale
Time frame: Baseline (32-36 weeks' gestation), 2 months postpartum, and 6 months postpartum
Frequency of Mothers and Babies Skills Use
Time frame: 6 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No. Data from this small pilot will not be made available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.