mHealth Mindfulness Intervention for Postpartum Depression

Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Kaiser Permanente

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for pregnant Black and Latina women under 30 weeks gestation, with moderate depression scores (PHQ-9 score of 10-19), receiving prenatal care at KPNC. Participants must own a smartphone or computer with internet access and speak English or Spanish. Women who regularly practice stress reduction or have cognitive impairments, or are deaf cannot participate.

Exclusion Criteria

I am deaf.

I have difficulty with thinking or memory.

Treatment Details

The study compares two digital self-paced stress reduction programs to see which is more effective in preventing postpartum depression among high-risk pregnant Black and Latina women. It also explores the ease of integrating these programs into a large healthcare system.

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

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

Group II: Active controlActive Control1 Intervention

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