mHealth Mindfulness Intervention for Pregnant Black and Latina Women at Risk of Postpartum Depression
- Conditions
- Post Partum DepressionPerinatal Depression
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 600
- 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
- Regular stress reduction practice with a mindfulness component (e.g., meditation or yoga more than twice a week)
- Deaf
- Acting as gestational carrier/surrogate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Patient Health Questionnaire-9 7 weeks postpartum Depression scale; total score range of 0-27; higher scores indicate higher depression.
- Secondary Outcome Measures
Name Time Method Generalized Anxiety Disorder 7-item scale 7 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 7 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.
Perceived Stress Scale 7 weeks postpartum 10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress
Trial Locations
- Locations (1)
Kaiser Permanente Northern California
🇺🇸Oakland, California, United States
Kaiser Permanente Northern California🇺🇸Oakland, California, United States