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

Kaiser Permanente logo

Kaiser Permanente

Status and phase

Active, not recruiting
Phase 3

Conditions

Perinatal Depression
Post Partum Depression

Treatments

Behavioral: Stress reduction program 'B'
Behavioral: Stress reduction program 'A'

Study type

Interventional

Funder types

Other

Identifiers

NCT05186272
1693692

Details and patient eligibility

About

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.

Enrollment

600 estimated patients

Sex

Female

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

600 participants in 2 patient groups

Intervention
Experimental group
Description:
Use of mHealth stress reduction program 'A' app 5-20 min daily for 6 weeks
Treatment:
Behavioral: Stress reduction program 'A'
Active control
Active Comparator group
Description:
Use of mHealth stress reduction program 'B' app 5-20 min daily for 6 weeks
Treatment:
Behavioral: Stress reduction program 'B'

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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