Post Partum DepressionPhase 3NCT05186272
mHealth Mindfulness Intervention for Pregnant Black and Latina Women at Risk of Postpartum Depression
A Phase 3 study testing Stress reduction program 'A' and Stress reduction program 'B' in people with Post Partum Depression and Perinatal Depression, run by Kaiser Permanente at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post Partum Depression, Perinatal Depression
- What is being tested?
- Stress reduction program 'A' and Stress reduction program 'B'
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2022to Dec 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Northern California
Oakland, California, 94611
About this study
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.
- Conditions
- Post Partum Depression, Perinatal Depression
- Being tested
- Stress reduction program 'A', Stress reduction program 'B'
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress reduction program 'A'Behavioural
Participants will use stress reduction program 'A' app 10-20 min per day for 6 weeks.
Stress reduction program 'B'Behavioural
Participants will use stress reduction program 'B' app 10-20 min per day for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Use of mHealth stress reduction program 'A' app 5-20 min daily for 6 weeks Receives: Behavioral: Stress reduction program 'A' |
| Active control | Active comparator | Use of mHealth stress reduction program 'B' app 5-20 min daily for 6 weeks Receives: Behavioral: Stress reduction program 'B' |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9
Depression scale; total score range of 0-27; higher scores indicate higher depression.
Measured: Baseline
Patient Health Questionnaire-9
Depression scale; total score range of 0-27; higher scores indicate higher depression.
Measured: 6-week follow-up
Patient Health Questionnaire-9
Depression scale; total score range of 0-27; higher scores indicate higher depression.
Measured: 7 weeks postpartum
Secondary outcomes (9)
Perceived Stress Scale
10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress
Measured: Baseline
Perceived Stress Scale
10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress
Measured: 6-week follow-up
Perceived Stress Scale
10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start14 Jun 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Partum DepressionStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186272
- Sponsor's protocol ID
- 1693692
- Status last verified
- Jul 2025
- First submitted
- 14 Dec 2021
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40935422
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth Mindfulness Intervention for Pregnant Black and Latina Women at Risk of Postpartum Depression
- ClinicalTrials.gov ID
- NCT05186272
- Acronym / sponsor ID
- 1693692
- Conditions
- Post Partum Depression, Perinatal Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Stress reduction program 'A'Use of mHealth stress reduction program 'A' app 5-20 min daily for 6 weeks |
| Active control | Active comparator | Behavioral: Stress reduction program 'B'Use of mHealth stress reduction program 'B' app 5-20 min daily for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years
- Current Kaiser Permanente Permanente Northern California (KPNC) member
- Pregnant woman receiving prenatal care at KPNC
- Gestational age <30 weeks
- Singleton pregnancy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress reduction program 'A'Participants will use stress reduction program 'A' app 10-20 min per day for 6 weeks. | Behavioural | Intervention |
| Stress reduction program 'B'Participants will use stress reduction program 'B' app 10-20 min per day for 6 weeks. | Behavioural | Active control |
Primary outcome
Patient Health Questionnaire-9
Time frame: Baseline
Depression scale; total score range of 0-27; higher scores indicate higher depression.
Patient Health Questionnaire-9
Time frame: 6-week follow-up
Depression scale; total score range of 0-27; higher scores indicate higher depression.
Patient Health Questionnaire-9
Time frame: 7 weeks postpartum
Depression scale; total score range of 0-27; higher scores indicate higher depression.
9 secondary outcomes
Perceived Stress Scale
Time frame: Baseline
Perceived Stress Scale
Time frame: 6-week follow-up
Perceived Stress Scale
Time frame: 7 weeks postpartum
Generalized Anxiety Disorder 7-item scale
Time frame: Baseline
Generalized Anxiety Disorder 7-item scale
Time frame: 6-week follow-up
Generalized Anxiety Disorder 7-item scale
Time frame: 7 weeks postpartum
Promis Sleep Disturbance - Short Form 6a
Time frame: Baseline
Promis Sleep Disturbance - Short Form 6a
Time frame: 6-week follow-up
Promis Sleep Disturbance - Short Form 6a
Time frame: 7 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Derived from this study: PubMed 40935422Kubo 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.
- Individual participant dataSharing planned: Yes. 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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A Web-based Intervention Program for Postpartum Depression
Postpartum Depression (PPD), Web-based Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stress reduction program 'A' and Stress reduction program 'B' in people with Post Partum Depression and Perinatal Depression, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05186272, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.