mHealth Mindfulness Intervention for Pregnant Black and Latina Women at Risk of Postpartum Depression
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Kaiser Permanente
- Enrollment
- 600
- Locations
- 2
- Primary Endpoint
- Patient Health Questionnaire-9
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
- •Acting as gestational carrier/surrogate
Outcomes
Primary Outcomes
Patient Health Questionnaire-9
Time Frame: 7 weeks postpartum
Depression scale; total score range of 0-27; higher scores indicate higher depression.
Secondary Outcomes
- Generalized Anxiety Disorder 7-item scale(7 weeks postpartum)
- Promis Sleep Disturbance - Short Form 6a(7 weeks postpartum)
- Perceived Stress Scale(7 weeks postpartum)