mHealth Mindfulness Intervention for Pregnant Black and Latina Women at Risk of Postpartum Depression

Postpartum depression (PPD) is associated with significant health consequences for mothers and children, and the current COVID-19 pandemic has had a major impact on the mental health of particularly vulnerable populations including pregnant Black and Latina women. There is an urgent need for evidence-based, accessible, and scalable mental health care options for these high-risk, vulnerable women. This study aims to: (a) compare the effectiveness of two digitally-delivered self-paced stress reduction programs in pregnant Black and Latina women at increased risk of PPD; and (b) examine barriers and facilitators to implementation within a large healthcare system.

Study Overview

• Status: Active, not recruiting
• Conditions: Post Partum Depression; Perinatal Depression
• Intervention / Treatment: Behavioral: Stress reduction program 'A'; Behavioral: Stress reduction program 'B'

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94611
      • Kaiser Permanente Northern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years
• Current Kaiser Permanente Permanente Northern California (KPNC) member
• Pregnant woman receiving prenatal care at KPNC
• Gestational age <30 weeks
• Singleton pregnancy
• Self-identify as Black and/or Latina
• Moderate to moderately severe depressive symptoms (PHQ-9 score between 10 and 19) and no indication of suicidality
• Owns a device with internet access
• English- or Spanish-speaking

Exclusion Criteria:

• Regular stress reduction practice with a mindfulness component (e.g., meditation or yoga more than twice a week)
• Deaf
• Blind
• Acting as gestational carrier/surrogate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Use of mHealth stress reduction program 'A' app 5-20 min daily for 6 weeks	Behavioral: Stress reduction program 'A'; Participants will use stress reduction program 'A' app 10-20 min per day for 6 weeks.
Active Comparator: Active control; Use of mHealth stress reduction program 'B' app 5-20 min daily for 6 weeks	Behavioral: Stress reduction program 'B'; Participants will use stress reduction program 'B' app 10-20 min per day for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9	Depression scale; total score range of 0-27; higher scores indicate higher depression.	Baseline
Patient Health Questionnaire-9	Depression scale; total score range of 0-27; higher scores indicate higher depression.	6-week follow-up
Patient Health Questionnaire-9	Depression scale; total score range of 0-27; higher scores indicate higher depression.	7 weeks postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress Scale	10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress	Baseline
Perceived Stress Scale	10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress	6-week follow-up
Generalized Anxiety Disorder 7-item scale	Anxiety scale; total score for the seven items ranges from 0 to 21; higher scores indicate greater anxiety.	Baseline
Generalized Anxiety Disorder 7-item scale	Anxiety scale; total score for the seven items ranges from 0 to 21; higher scores indicate greater anxiety.	6-week follow-up
Promis Sleep Disturbance - Short Form 6a	Scale is composed of 6 items developed to assess the domain of sleep disturbances in the past 7 days. Scores range 6-30 with higher scores indicating greater sleep disturbance.	Baseline
Promis Sleep Disturbance - Short Form 6a	Scale is composed of 6 items developed to assess the domain of sleep disturbances in the past 7 days. Scores range 6-30 with higher scores indicating greater sleep disturbance.	6-week follow-up
Perceived Stress Scale	10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress	7 weeks postpartum
Generalized Anxiety Disorder 7-item scale	Anxiety scale; total score for the seven items ranges from 0 to 21; higher scores indicate greater anxiety.	7 weeks postpartum
Promis Sleep Disturbance - Short Form 6a	Scale is composed of 6 items developed to assess the domain of sleep disturbances in the past 7 days. Scores range 6-30 with higher scores indicating greater sleep disturbance.	7 weeks postpartum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Resilient Coping Scale	4-item questionnaire that measures resilience and coping with stress using a 5-point Likert scale; Individual items are totaled and range from 4 to 20 with a higher score indicating high resiliency and coping skills. Scores can be categorized as low resilient copers (4-13), medium resilient copers (14-16), and high resilient copers (17-20).	Baseline
Brief Resilient Coping Scale	4-item questionnaire that measures resilience and coping with stress using a 5-point Likert scale; Individual items are totaled and range from 4 to 20 with a higher score indicating high resiliency and coping skills. Scores can be categorized as low resilient copers (4-13), medium resilient copers (14-16), and high resilient copers (17-20).	6-week follow-up
Brief Resilient Coping Scale	4-item questionnaire that measures resilience and coping with stress using a 5-point Likert scale; Individual items are totaled and range from 4 to 20 with a higher score indicating high resiliency and coping skills. Scores can be categorized as low resilient copers (4-13), medium resilient copers (14-16), and high resilient copers (17-20).	7 weeks postpartum
UCLA Loneliness Scale	20-item questionnaire assessing the respondent's subjective feelings of loneliness on a 4-point Likert scale; total scores range from 20 to 80 with higher scores correlating with higher degrees of loneliness. A score of 20-34 represents low levels of loneliness, 35-49 represent moderate levels of loneliness, 50-64 represent moderately high levels of loneliness, and 65 and higher represent high levels of loneliness.	Baseline
UCLA Loneliness Scale	20-item questionnaire assessing the respondent's subjective feelings of loneliness on a 4-point Likert scale; total scores range from 20 to 80 with higher scores correlating with higher degrees of loneliness. A score of 20-34 represents low levels of loneliness, 35-49 represent moderate levels of loneliness, 50-64 represent moderately high levels of loneliness, and 65 and higher represent high levels of loneliness.	6-week follow-up
UCLA Loneliness Scale	20-item questionnaire assessing the respondent's subjective feelings of loneliness on a 4-point Likert scale; total scores range from 20 to 80 with higher scores correlating with higher degrees of loneliness. A score of 20-34 represents low levels of loneliness, 35-49 represent moderate levels of loneliness, 50-64 represent moderately high levels of loneliness, and 65 and higher represent high levels of loneliness.	7 weeks postpartum
Mother-to-Infant Bonding Scale (MIBS)	8-item questionnaire designed to assess feelings of the birthing parent toward their baby. The MIBS has demonstrated acceptability and has good internal reliability. Scores range from 0 to 24, with lower scores indicating better parent-infant bonding.	7 weeks postpartum
Ages and Stages Questionnaire	Screens for delays in child development in 5 domains: communication, gross motor, fine motor, problem-solving, and personal-social skills. Scores are calculated based on the ASQ-3 scoring guide with scores above the cut-off point indicating typical development categorized as "on schedule" and scores in the zones indicating the need for monitoring or the need for further assessment categorized as "not on schedule."	7 weeks postpartum

Collaborators and Investigators

• Sponsor: Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Behavioral Symptoms; Mood Disorders; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 1693692

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share IPD with the National Institute of Mental Health Data Archive, including demographics, PHQ-9 scores, substance use survey, breastfeeding questionnaire, Brief Resilient Coping Scale, Mother-Infant Bonding Scale, Five Facet Mindfulness Questionnaire, Perceived Stress Scale, Generalized Anxiety Disorder 7-item, Everyday Discrimination Questionnaire, UCLA Loneliness Scale, Promis Sleep Disturbance Scale, Ages and Stages Questionnaire.
• IPD Sharing Time Frame: IPD will be available after publication of study main outcome findings and will be available indefinitely.
• IPD Sharing Access Criteria: Please see https://nda.nih.gov/nda/access-data-info for details.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No