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

NCT ID: NCT05186272

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-14
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Stress reduction program 'A'

Intervention Type: BEHAVIORAL

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

Active control

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

Group Type: ACTIVE_COMPARATOR

Stress reduction program 'B'

Intervention Type: BEHAVIORAL

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

Interventions

Stress reduction program 'A'

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

Intervention Type: BEHAVIORAL

Stress reduction program 'B'

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kaiser Permanente Northern California

Oakland, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40935422 (View on PubMed)

Other Identifiers

1693692

Identifier Type: -

Identifier Source: org_study_id