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Active, Not Recruiting

NCT Number: NCT05186272

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Post Partum Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Perinatal Depression Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Kaiser Permanente Northern California

Oakland, California, 94611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Current Kaiser Permanente Permanente Northern California (KPNC) member
  • Pregnant woman receiving prenatal care at KPNC
  • Gestational age <30 weeks
  • Singleton pregnancy
  • Self-identify as Black and/or Latina
  • Moderate to moderately severe depressive symptoms (PHQ-9 score between 10 and 19) and no indication of suicidality
  • Owns a device with internet access
  • English- or Spanish-speaking

Exclusion criteria

  • Regular stress reduction practice with a mindfulness component (e.g., meditation or yoga more than twice a week)
  • Deaf
  • Blind
  • Acting as gestational carrier/surrogate

Treatment and study plan

Stress reduction program 'A'

Behavioral

Participants will use stress reduction program 'A' app 10-20 min per day for 6 weeks.

Stress reduction program 'B'

Behavioral

Participants will use stress reduction program 'B' app 10-20 min per day for 6 weeks.

Primary outcomes

  1. Patient Health Questionnaire-9

    Time frame: Baseline

    Depression scale; total score range of 0-27; higher scores indicate higher depression.

  2. Patient Health Questionnaire-9

    Time frame: 6-week follow-up

    Depression scale; total score range of 0-27; higher scores indicate higher depression.

  3. Patient Health Questionnaire-9

    Time frame: 7 weeks postpartum

    Depression scale; total score range of 0-27; higher scores indicate higher depression.

Secondary outcomes

  1. Perceived Stress Scale

    Time frame: Baseline

    10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress

  2. Perceived Stress Scale

    Time frame: 6-week follow-up

    10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress

  3. Perceived Stress Scale

    Time frame: 7 weeks postpartum

    10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress

  4. Generalized Anxiety Disorder 7-item scale

    Time frame: Baseline

    Anxiety scale; total score for the seven items ranges from 0 to 21; higher scores indicate greater anxiety.

  5. Generalized Anxiety Disorder 7-item scale

    Time frame: 6-week follow-up

    Anxiety scale; total score for the seven items ranges from 0 to 21; higher scores indicate greater anxiety.

  6. Generalized Anxiety Disorder 7-item scale

    Time frame: 7 weeks postpartum

    Anxiety scale; total score for the seven items ranges from 0 to 21; higher scores indicate greater anxiety.

  7. Promis Sleep Disturbance - Short Form 6a

    Time frame: Baseline

    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.

  8. Promis Sleep Disturbance - Short Form 6a

    Time frame: 6-week follow-up

    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.

  9. Promis Sleep Disturbance - Short Form 6a

    Time frame: 7 weeks postpartum

    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.

Other outcomes

  1. Brief Resilient Coping Scale

    Time frame: Baseline

    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).

  2. Brief Resilient Coping Scale

    Time frame: 6-week follow-up

    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).

  3. Brief Resilient Coping Scale

    Time frame: 7 weeks postpartum

    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).

  4. UCLA Loneliness Scale

    Time frame: Baseline

    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.

  5. UCLA Loneliness Scale

    Time frame: 6-week follow-up

    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. UCLA Loneliness Scale

    Time frame: 7 weeks postpartum

    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. Mother-to-Infant Bonding Scale (MIBS)

    Time frame: 7 weeks postpartum

    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.

  8. Ages and Stages Questionnaire

    Time frame: 7 weeks postpartum

    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."

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 11, 2022
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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