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

Perinatal Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05186272
• Other study ID #: 1693692
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: June 14, 2022
• Est. completion date: March 1, 2025

Study information

• Verified date: May 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 600
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Perinatal Depression
• Post Partum Depression

Intervention

Behavioral:
• Stress reduction program 'A'
Participants will use stress reduction program 'A' app 10-20 min per day for 6 weeks.
• Stress reduction program 'B'
Participants will use stress reduction program 'B' app 10-20 min per day for 6 weeks.

Locations

Country	Name	City	State
United States	Kaiser Permanente Northern California	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire-9	Depression scale; total score range of 0-27; higher scores indicate higher depression.	Baseline
Primary	Patient Health Questionnaire-9	Depression scale; total score range of 0-27; higher scores indicate higher depression.	6-week follow-up
Primary	Patient Health Questionnaire-9	Depression scale; total score range of 0-27; higher scores indicate higher depression.	4 weeks postpartum
Secondary	Perceived Stress Scale	10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress	Baseline
Secondary	Perceived Stress Scale	10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress	6-week follow-up
Secondary	Perceived Stress Scale	10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress	4 weeks postpartum
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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