mHealth Mindfulness Intervention for Postpartum Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores ways to assist pregnant Black and Latina women at risk for postpartum depression, a common mental health issue after childbirth. The study compares two stress reduction programs delivered via a smartphone app, known as the mHealth mindfulness app, to determine which is most effective. Participants use the app daily for 5-20 minutes over six weeks. This trial suits pregnant women under 30 weeks along, who self-identify as Black or Latina, and have experienced moderate depressive symptoms but do not regularly practice stress-reduction techniques like yoga or meditation. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to important research that could soon benefit many others.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on mindfulness interventions, so it's likely you can continue your medications, but you should confirm with the trial organizers.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that mobile health (mHealth) mindfulness apps can safely help reduce postpartum depression. In previous studies, these apps increased social support and confidence for new mothers. No serious side effects were reported, indicating they are well-tolerated.
For the Stress Reduction Program 'B', studies indicate that mindfulness practices effectively reduce symptoms of postpartum depression. These methods have been used without major safety concerns.
Both treatments focus on mindfulness and stress reduction, which have been shown to be safe for many users. The treatments are digital and self-paced, making them easy to use. While no treatment is risk-free for everyone, past research has generally found these programs to be safe.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the mHealth mindfulness app for postpartum depression because it offers a convenient, digital approach to managing symptoms, unlike traditional therapies like antidepressants or in-person therapy sessions. This app is designed to be used daily for just 5-20 minutes, making it accessible for new moms who may struggle to find time for lengthy treatments. Additionally, it incorporates stress reduction techniques that are tailored to the unique needs of postpartum women, potentially offering a more personalized treatment experience.
What evidence suggests that this trial's treatments could be effective for postpartum depression?
Research has shown that mobile health (mHealth) mindfulness apps effectively reduce stress, anxiety, and depression symptoms in pregnant and new mothers. These apps assist in managing postpartum depression by offering easy-to-follow stress reduction techniques. Mindfulness activities can lower stress and help new mothers adjust to motherhood.
In this trial, participants will use either the mHealth stress reduction program 'A' app or the stress reduction program 'B' app. Studies have found that similar mindfulness activities in Stress Reduction Program 'B' can greatly reduce depression symptoms during and after pregnancy. These activities help reduce stress and support mothers' mental health. Both programs provide easy-to-access digital solutions to improve mental health for new mothers.16789Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use mHealth stress reduction program 'A' or 'B' app 5-20 min daily for 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- mHealth mindfulness app
- Nature sounds
- Stress reduction program 'A'
- Stress reduction program 'B'
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kaiser Permanente
Lead Sponsor