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

NCT05186272 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 1693692
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Partum Depression; Perinatal Depression

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Perceived Stress Scale

  Baseline

• Perceived Stress Scale

  6-week follow-up

• Perceived Stress Scale

  7 weeks postpartum

• Generalized Anxiety Disorder 7-item scale

  Baseline

• Generalized Anxiety Disorder 7-item scale

  6-week follow-up

Other Outcomes (8)

• Brief Resilient Coping Scale

  Baseline

• Brief Resilient Coping Scale

  6-week follow-up

• Brief Resilient Coping Scale

  7 weeks postpartum

Study Arms (2)

Intervention

EXPERIMENTAL

Use of mHealth stress reduction program 'A' app 5-20 min daily for 6 weeks

Behavioral: Stress reduction program 'A'

Active control

ACTIVE COMPARATOR

Use of mHealth stress reduction program 'B' app 5-20 min daily for 6 weeks

Behavioral: Stress reduction program 'B'

Interventions

Stress reduction program 'A' BEHAVIORAL

Participants will use stress reduction program 'A' app 10-20 min per day for 6 weeks.

Intervention

Stress reduction program 'B' BEHAVIORAL

Participants will use stress reduction program 'B' app 10-20 min per day for 6 weeks.

Active control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Northern California

Oakland, California, 94611, United States

Location

Related Publications (1)

• Kubo A, Kurtovich E, Aghaee S, Rubin MV, Gomez Chavez L, Brown SD, Ridout K, Bhalala M, Williams A, Elmer M, Ramsey M, Suazo S, Chess A, Quesenberry CP, Avalos LA. Mindfulness-based mHealth intervention for pregnant black and Latina women at high risk of postpartum depression-the Healthy Mama and Baby study: protocol and data overview for a randomised controlled trial in an integrated healthcare delivery system. BMJ Open. 2025 Sep 10;15(9):e103064. doi: 10.1136/bmjopen-2025-103064.

  PMID: 40935422 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 11, 2022
• Study Start: June 14, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: IPD will be available after publication of study main outcome findings and will be available indefinitely.
• Access Criteria: Please see https://nda.nih.gov/nda/access-data-info for details.

Locations

US (1)