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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Use of mHealth stress reduction program 'A' app 5-20 min daily for 6 weeks |
|
| Active control | Active Comparator | Use of mHealth stress reduction program 'B' app 5-20 min daily for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stress reduction program 'A' | Behavioral | Participants will use stress reduction program 'A' app 10-20 min per day for 6 weeks. |
|
| 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. | 7 weeks postpartum |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Resilient Coping Scale | 4-item questionnaire that measures resilience and coping with stress using a 5-point Likert scale; Individual items are totaled and range from 4 to 20 with a higher score indicating high resiliency and coping skills. Scores can be categorized as low resilient copers (4-13), medium resilient copers (14-16), and high resilient copers (17-20). | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Northern California | Oakland | California | 94611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40935422 | Derived | Kubo A, Kurtovich E, Aghaee S, Rubin MV, Gomez Chavez L, Brown SD, Ridout K, Bhalala M, Williams A, Elmer M, Ramsey M, Suazo S, Chess A, Quesenberry CP, Avalos LA. Mindfulness-based mHealth intervention for pregnant black and Latina women at high risk of postpartum depression-the Healthy Mama and Baby study: protocol and data overview for a randomised controlled trial in an integrated healthcare delivery system. BMJ Open. 2025 Sep 10;15(9):e103064. doi: 10.1136/bmjopen-2025-103064. |
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We will share IPD with the National Institute of Mental Health Data Archive, including demographics, PHQ-9 scores, substance use survey, breastfeeding questionnaire, Brief Resilient Coping Scale, Mother-Infant Bonding Scale, Five Facet Mindfulness Questionnaire, Perceived Stress Scale, Generalized Anxiety Disorder 7-item, Everyday Discrimination Questionnaire, UCLA Loneliness Scale, Promis Sleep Disturbance Scale, Ages and Stages Questionnaire.
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IPD will be available after publication of study main outcome findings and will be available indefinitely.
Please see https://nda.nih.gov/nda/access-data-info for details.
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Stress reduction program 'B' | Behavioral | Participants will use stress reduction program 'B' app 10-20 min per day for 6 weeks. |
|
| 6-week follow-up |
| Perceived Stress Scale | 10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress | 7 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. | 7 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. | 7 weeks postpartum |
| Brief Resilient Coping Scale | 4-item questionnaire that measures resilience and coping with stress using a 5-point Likert scale; Individual items are totaled and range from 4 to 20 with a higher score indicating high resiliency and coping skills. Scores can be categorized as low resilient copers (4-13), medium resilient copers (14-16), and high resilient copers (17-20). | 6-week follow-up |
| Brief Resilient Coping Scale | 4-item questionnaire that measures resilience and coping with stress using a 5-point Likert scale; Individual items are totaled and range from 4 to 20 with a higher score indicating high resiliency and coping skills. Scores can be categorized as low resilient copers (4-13), medium resilient copers (14-16), and high resilient copers (17-20). | 7 weeks postpartum |
| UCLA Loneliness Scale | 20-item questionnaire assessing the respondent's subjective feelings of loneliness on a 4-point Likert scale; total scores range from 20 to 80 with higher scores correlating with higher degrees of loneliness. A score of 20-34 represents low levels of loneliness, 35-49 represent moderate levels of loneliness, 50-64 represent moderately high levels of loneliness, and 65 and higher represent high levels of loneliness. | Baseline |
| UCLA Loneliness Scale | 20-item questionnaire assessing the respondent's subjective feelings of loneliness on a 4-point Likert scale; total scores range from 20 to 80 with higher scores correlating with higher degrees of loneliness. A score of 20-34 represents low levels of loneliness, 35-49 represent moderate levels of loneliness, 50-64 represent moderately high levels of loneliness, and 65 and higher represent high levels of loneliness. | 6-week follow-up |
| UCLA Loneliness Scale | 20-item questionnaire assessing the respondent's subjective feelings of loneliness on a 4-point Likert scale; total scores range from 20 to 80 with higher scores correlating with higher degrees of loneliness. A score of 20-34 represents low levels of loneliness, 35-49 represent moderate levels of loneliness, 50-64 represent moderately high levels of loneliness, and 65 and higher represent high levels of loneliness. | 7 weeks postpartum |
| Mother-to-Infant Bonding Scale (MIBS) | 8-item questionnaire designed to assess feelings of the birthing parent toward their baby. The MIBS has demonstrated acceptability and has good internal reliability. Scores range from 0 to 24, with lower scores indicating better parent-infant bonding. | 7 weeks postpartum |
| Ages and Stages Questionnaire | Screens for delays in child development in 5 domains: communication, gross motor, fine motor, problem-solving, and personal-social skills. Scores are calculated based on the ASQ-3 scoring guide with scores above the cut-off point indicating typical development categorized as "on schedule" and scores in the zones indicating the need for monitoring or the need for further assessment categorized as "not on schedule." | 7 weeks postpartum |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |