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

Study Overview
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Brief Summary
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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.

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

Conditions
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Post Partum Depression, Perinatal Depression

Intervention / Treatment
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* Behavioral: Stress reduction program 'A'
* Behavioral: Stress reduction program 'B'


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women seeking prenatal care at KPNC Identify as Black or Latina Current prenatal PHQ-9 score 10-19 Gestational age <30 weeks Owns a smartphone or computer with internet access English- or Spanish-speaking Exclusion Criteria: Regular (3 times per week or more) stress reduction practice Cognitively impaired Deaf

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Use of mHealth stress reduction program 'A' app 5-20 min daily for 6 weeks | Behavioral: Stress reduction program 'A'<br>* Participants will use stress reduction program 'A' app 10-20 min per day for 6 weeks.<br>|
| Active Comparator: Active control<br>Use of mHealth stress reduction program 'B' app 5-20 min daily for 6 weeks | Behavioral: Stress reduction program 'B'<br>* Participants will use stress reduction program 'B' app 10-20 min per day for 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-9 | Depression scale; total score range of 0-27; higher scores indicate higher depression. | Baseline | 
| Patient Health Questionnaire-9 | Depression scale; total score range of 0-27; higher scores indicate higher depression. | 6-week follow-up | 
| Patient Health Questionnaire-9 | Depression scale; total score range of 0-27; higher scores indicate higher depression. | 4 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale | 10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress | Baseline | 
| Perceived Stress Scale | 10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress | 6-week follow-up | 
| Perceived Stress Scale | 10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress | 4 weeks postpartum | 
| Generalized Anxiety Disorder 7-item scale | Anxiety scale; total score for the seven items ranges from 0 to 21; higher scores indicate greater anxiety. | Baseline | 
| Generalized Anxiety Disorder 7-item scale | Anxiety scale; total score for the seven items ranges from 0 to 21; higher scores indicate greater anxiety. | 6-week follow-up | 
| Generalized Anxiety Disorder 7-item scale | Anxiety scale; total score for the seven items ranges from 0 to 21; higher scores indicate greater anxiety. | 4 weeks postpartum | 
| Promis Sleep Disturbance - Short Form 6a | Scale is composed of 6 items developed to assess the domain of sleep disturbances in the past 7 days. Scores range 6-30 with higher scores indicating greater sleep disturbance. | Baseline | 
| Promis Sleep Disturbance - Short Form 6a | Scale is composed of 6 items developed to assess the domain of sleep disturbances in the past 7 days. Scores range 6-30 with higher scores indicating greater sleep disturbance. | 6-week follow-up | 
| Promis Sleep Disturbance - Short Form 6a | Scale is composed of 6 items developed to assess the domain of sleep disturbances in the past 7 days. Scores range 6-30 with higher scores indicating greater sleep disturbance. | 4 weeks postpartum |