mHealth Mindfulness Intervention for Pregnant Black and Latina Women at Risk of Postpartum Depression
Primary Purpose
Post Partum Depression, Perinatal Depression
Status
Enrolling by invitation
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Stress reduction program 'A'
Stress reduction program 'B'
Sponsored by
About this trial
This is an interventional prevention trial for Post Partum Depression
Eligibility Criteria
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
Sites / Locations
- Kaiser Permanente Northern California
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Active control
Arm Description
Use of mHealth stress reduction program 'A' app 5-20 min daily for 6 weeks
Use of mHealth stress reduction program 'B' app 5-20 min daily for 6 weeks
Outcomes
Primary Outcome Measures
Patient Health Questionnaire-9
Depression scale; total score range of 0-27; higher scores indicate higher depression.
Patient Health Questionnaire-9
Depression scale; total score range of 0-27; higher scores indicate higher depression.
Patient Health Questionnaire-9
Depression scale; total score range of 0-27; higher scores indicate higher depression.
Secondary Outcome Measures
Perceived Stress Scale
10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress
Perceived Stress Scale
10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress
Perceived Stress Scale
10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress
Generalized Anxiety Disorder 7-item scale
Anxiety scale; total score for the seven items ranges from 0 to 21; higher scores indicate greater anxiety.
Generalized Anxiety Disorder 7-item scale
Anxiety scale; total score for the seven items ranges from 0 to 21; higher scores indicate greater anxiety.
Generalized Anxiety Disorder 7-item scale
Anxiety scale; total score for the seven items ranges from 0 to 21; higher scores indicate greater anxiety.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05186272
Brief Title
mHealth Mindfulness Intervention for Pregnant Black and Latina Women at Risk of Postpartum Depression
Official Title
mHealth Mindfulness Intervention for Pregnant Black and Latina Women at Risk of Postpartum Depression
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Depression, Perinatal Depression
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Use of mHealth stress reduction program 'A' app 5-20 min daily for 6 weeks
Arm Title
Active control
Arm Type
Active Comparator
Arm Description
Use of mHealth stress reduction program 'B' app 5-20 min daily for 6 weeks
Intervention Type
Behavioral
Intervention Name(s)
Stress reduction program 'A'
Intervention Description
Participants will use stress reduction program 'A' app 10-20 min per day for 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Stress reduction program 'B'
Intervention Description
Participants will use stress reduction program 'B' app 10-20 min per day for 6 weeks.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire-9
Description
Depression scale; total score range of 0-27; higher scores indicate higher depression.
Time Frame
Baseline
Title
Patient Health Questionnaire-9
Description
Depression scale; total score range of 0-27; higher scores indicate higher depression.
Time Frame
6-week follow-up
Title
Patient Health Questionnaire-9
Description
Depression scale; total score range of 0-27; higher scores indicate higher depression.
Time Frame
4 weeks postpartum
Secondary Outcome Measure Information:
Title
Perceived Stress Scale
Description
10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress
Time Frame
Baseline
Title
Perceived Stress Scale
Description
10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress
Time Frame
6-week follow-up
Title
Perceived Stress Scale
Description
10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress
Time Frame
4 weeks postpartum
Title
Generalized Anxiety Disorder 7-item scale
Description
Anxiety scale; total score for the seven items ranges from 0 to 21; higher scores indicate greater anxiety.
Time Frame
Baseline
Title
Generalized Anxiety Disorder 7-item scale
Description
Anxiety scale; total score for the seven items ranges from 0 to 21; higher scores indicate greater anxiety.
Time Frame
6-week follow-up
Title
Generalized Anxiety Disorder 7-item scale
Description
Anxiety scale; total score for the seven items ranges from 0 to 21; higher scores indicate greater anxiety.
Time Frame
4 weeks postpartum
Title
Promis Sleep Disturbance - Short Form 6a
Description
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.
Time Frame
Baseline
Title
Promis Sleep Disturbance - Short Form 6a
Description
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.
Time Frame
6-week follow-up
Title
Promis Sleep Disturbance - Short Form 6a
Description
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.
Time Frame
4 weeks postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kaiser Permanente Northern California
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
mHealth Mindfulness Intervention for Pregnant Black and Latina Women at Risk of Postpartum Depression
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