mHealth Mindfulness Intervention for Postpartum Depression

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Kaiser Permanente

Disqualifiers: Regular stress reduction, Cognitively impaired, Deaf

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

600 Participants Needed

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.

Inclusion Criteria

Gestational age <30 weeks

Owns a smartphone or computer with internet access

Women seeking prenatal care at KPNC

Exclusion Criteria

I am deaf.

Regular (3 times per week or more) stress reduction practice

I have difficulty with thinking or memory.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use mHealth stress reduction program 'A' or 'B' app 5-20 min daily for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• mHealth mindfulness app
• Nature sounds
• Stress reduction program 'A'
• Stress reduction program 'B'

Trial Overview 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.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

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

Group II: Active control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+