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

Sponsor

Kaiser Permanente (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05186272

Collaborator

(none)

600

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post Partum Depression Perinatal Depression	Behavioral: Stress reduction program 'A' Behavioral: Stress reduction program 'B'	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Intervention

Use of mHealth stress reduction program 'A' app 5-20 min daily for 6 weeks

Behavioral: Stress reduction program 'A'

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

Active Comparator: Active control

Use of mHealth stress reduction program 'B' app 5-20 min daily for 6 weeks

Behavioral: Stress reduction program 'B'

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

Outcome Measures

Primary Outcome Measures

Patient Health Questionnaire-9 [Baseline]
Depression scale; total score range of 0-27; higher scores indicate higher depression.
Patient Health Questionnaire-9 [6-week follow-up]
Depression scale; total score range of 0-27; higher scores indicate higher depression.
Patient Health Questionnaire-9 [4 weeks postpartum]
Depression scale; total score range of 0-27; higher scores indicate higher depression.

Secondary Outcome Measures

Perceived Stress Scale [Baseline]
10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress
Perceived Stress Scale [6-week follow-up]
10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress
Perceived Stress Scale [4 weeks postpartum]
10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress
Generalized Anxiety Disorder 7-item scale [Baseline]
Anxiety scale; total score for the seven items ranges from 0 to 21; higher scores indicate greater anxiety.
Generalized Anxiety Disorder 7-item scale [6-week follow-up]
Anxiety scale; total score for the seven items ranges from 0 to 21; higher scores indicate greater anxiety.
Generalized Anxiety Disorder 7-item scale [4 weeks postpartum]
Anxiety scale; total score for the seven items ranges from 0 to 21; higher scores indicate greater anxiety.
Promis Sleep Disturbance - Short Form 6a [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.
Promis Sleep Disturbance - Short Form 6a [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.
Promis Sleep Disturbance - Short Form 6a [4 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Kaiser Permanente

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kaiser Permanente

ClinicalTrials.gov Identifier:

NCT05186272

Other Study ID Numbers:

1693692

First Posted:

Jan 11, 2022

Last Update Posted:

Jun 3, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depression, Postpartum

Depression

Depressive Disorder

Study Results

No Results Posted as of Jun 3, 2022