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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks postpartum

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient Health Questionnaire-9

Secondary outcome measures

Generalized Anxiety Disorder 7-item scale

Perceived Stress Scale

Promis Sleep Disturbance - Short Form 6a

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor

538 Previous Clinical Trials

24,113,228 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there restrictions for who is eligible to participate in this research project?

"Eligibility criteria for this clinical trial include a formal diagnosis of postpartum depression and being between 18-99 years old. Around 600 individuals are planned to be enrolled in the study."

Answered by AI

Could you inform me if this research study has any age restrictions?

"Eligibility criteria for this clinical trial include being between 18 and 99 years old."

Answered by AI

Has the FDA greenlit this particular therapeutic method?

"Intervention has received a score of 3 for safety. This is due to it being a Phase 3 trial, which suggests that not only does the intervention have some evidence backing its efficacy, but also that there is data supporting its safety from multiple rounds of testing."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

mHealth Mindfulness Intervention for Pregnant Black and Latina Women at Risk of Postpartum Depression

2022. "mHealth Mindfulness Intervention for Pregnant Black and Latina Women at Risk of Postpartum Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05186272.