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

Phase 3

• Conditions: Post Partum Depression; Perinatal Depression
• Interventions: Behavioral: Stress reduction program 'B'; Behavioral: Stress reduction program 'A'

• Registration Number: NCT05186272
• Lead Sponsor: Kaiser Permanente

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-11
• Study Start: 2022-06-14
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-02
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• Women seeking prenatal care at KPNC
• Identify as Black or Latina
• Current prenatal PHQ-9 score 10-19
• Gestational age <30 weeks
• Owns a smartphone or computer with internet access
• English- or Spanish-speaking

Exclusion Criteria

• Regular (3 times per week or more) stress reduction practice
• Cognitively impaired
• Deaf

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active control	Stress reduction program 'B'	Use of mHealth stress reduction program 'B' app 5-20 min daily for 6 weeks
Intervention	Stress reduction program 'A'	Use of mHealth stress reduction program 'A' app 5-20 min daily for 6 weeks

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9	4 weeks postpartum	Depression scale; total score range of 0-27; higher scores indicate higher depression.

Secondary Outcome Measures

Name	Time	Method
Perceived Stress Scale	4 weeks postpartum	10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress
Generalized Anxiety Disorder 7-item scale	4 weeks postpartum	Anxiety scale; total score for the seven items ranges from 0 to 21; higher scores indicate greater anxiety.
Promis Sleep Disturbance - Short Form 6a	4 weeks postpartum	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.

Trial Locations

Locations (1)

Kaiser Permanente Northern California; 🇺🇸 Oakland, California, United States