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mHealth Mindfulness Intervention for Postpartum Depression

Phase 3
Waitlist Available
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Deaf
Cognitively impaired
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-week follow-up
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trialaims to compare 2 digital stress reduction programs in pregnant Black & Latina women at risk of PPD, to understand barriers & facilitators to implementation & make mental health care more accessible & scalable.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the interventions involve non-invasive stress reduction programs delivered digitally, significant side effects are not anticipated. However, participants may experience varying levels of emotional discomfort when engaging with program content.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am deaf.
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I have difficulty with thinking or memory.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-week follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-week follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient Health Questionnaire-9
Secondary study objectives
Generalized Anxiety Disorder 7-item scale
Perceived Stress Scale
Promis Sleep Disturbance - Short Form 6a

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor
556 Previous Clinical Trials
27,732,136 Total Patients Enrolled
3 Trials studying Postpartum Depression
269 Patients Enrolled for Postpartum Depression

Media Library

mHealth mindfulness app Clinical Trial Eligibility Overview. Trial Name: NCT05186272 — Phase 3
Postpartum Depression Research Study Groups: Intervention, Active control
Postpartum Depression Clinical Trial 2023: mHealth mindfulness app Highlights & Side Effects. Trial Name: NCT05186272 — Phase 3
mHealth mindfulness app 2023 Treatment Timeline for Medical Study. Trial Name: NCT05186272 — Phase 3
~37 spots leftby Mar 2025
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