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

NCT06365645 | Active Not Recruiting

• 1 other identifier: 2138752
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Postpartum Depression; Postpartum Anxiety; Stress

Keywords

perinatal mental health; digital health; postpartum depression; postpartum anxiety; smartphone application (app)

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Six months postpartum

Secondary Outcomes (6)

• Inventory for Depression Scale

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

• General Anxiety Disorder-7

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

• Perceived Stress-Scale 4

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

• Dyadic Adjustment Scale

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

• UCLA Loneliness Scale

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

Other Outcomes (2)

• De novo psychiatric diagnosis

  Within one week of delivery, 2 months postpartum, 4 months postpartum, and 6 months postpartum

• Screening positive on study survey

  Within one week of delivery, 2 months postpartum, 4 months postpartum, and 6 months postpartum

Study Arms (2)

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.

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.

Behavioral: M.Bapp

Interventions

M.Bapp BEHAVIORAL

Please see experimental group description.

M.Bapp

App-based parenting education BEHAVIORAL

Please see active comparator group description.

App-based digital parenting education

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Patients must be pregnant in order to participate
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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'.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

Depression, Postpartum; Alzheimer Disease

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants who consent will be unaware of the existence of another version of M.Bapp. Obstetric care providers will be aware of participant's enrollment in this trial but not of the study group and will be encouraged to provide standardized care. The research team and outcomes assessors will be blindd to the randomization group.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 15, 2024
• Study Start: June 7, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)