Perinatal DepressionNCT05345834
The DC Mother-Infant Behavioral Wellness Program
A study testing Patient Navigation and Adapted Cognitive-Behavioral Therapy in people with Perinatal Depression and Perinatal Anxiety, run by Children's National Research Institute at 1 site in United States.
Trial summary
This randomized controlled study will examine the effectiveness of patient navigation with culturally adapted cognitive-behavioral interventions and peer support groups for low-income Black/of African Descent pregnant women who are experiencing stress, anxiety, and/or depression. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perinatal Depression, Perinatal Anxiety, Prenatal Stress
- What is being tested?
- Patient Navigation and Adapted Cognitive-Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2022to 30 Nov 2026
- Phase
- Interventional
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Black/of African Descent
- Pregnant (gestational weeks ≤ 28 weeks)
- Age 18-45
- English proficient
- Receiving services in 1 of 4 study sites above
- Low-income: i.e., receiving Medicaid
- Subthreshold or threshold risk for maternal distress (stress, depression, and/or anxiety)
- Able to provide consent
Who cannot join
- age <18
- Currently under the influence of a substance(s)
- Experiencing psychosis
- Critical (clinical) risk: actively suicidal or homicidal
- Not Black/of African Descent
- Planning to deliver outside DC
Trial locations and contacts
1 site in 1 country.
United States1 site
Unity Healthcare - Brentwood
Washington D.C., District of Columbia, 20018
About this study
Official title: Advancing Perinatal Mental Health and Well-Being: The DC Mother-Infant Behavioral Wellness Program
This randomized controlled study will examine the effectiveness of patient navigation with culturally adapted cognitive-behavioral interventions and peer support groups for low-income Black/of African Descent pregnant women who are experiencing stress, anxiety, and/or depression.
Read the detailed description
The overarching objective is to develop and evaluate a collaborative, multi-dimensional and culturally tailored community-based model of integrated perinatal MH care. The target population is low-income Black/of African descent women with pregnancy-related stress, anxiety, and depression. There are two specific aims: (1) to refine an individualized plan to integrate patient navigation and a culturally adapted cognitive-behavioral (CBT) intervention for low-income Black/of African Descent women designed to increase recruitment and retention within the healthcare community system, and (2) through a two-arm prospective randomized controlled design, women who are subthreshold and threshold risk for prenatal stress, depression and/or anxiety will participate in one of two interventions: (a) existing prenatal intervention (usual care); or (b) patient navigation plus culturally adapted CBT, and peer support groups.
The investigators will screen 1,000 low-income pregnant AA women (18-45 years of age) in their second pregnancy visit with validated tools for stress, anxiety, and depression. A total of 700 study participants will be recruited from urban prenatal care centers in the Washington DC area and will be randomized Usual Care of Intervention conditions above (n=350/condition). Following randomization, participants will participate in a diagnostic interview based on DSM-5 criteria to 'self-select' themselves into 1 of 2 groups (i.e., 'threshold' or 'subthreshold'). Threshold includes women who meet criteria for depression or anxiety based on DSM-5 diagnostic criteria. Subthreshold includes all other women who do not meet DSM criteria). In the intervention arm, participants in the threshold group will receive a 1:1 CBT treatment intervention, and participants in the subthreshold group will receive a group CBT intervention. Both threshold groups will also include patient navigation and participation in a peer support group. Participants will complete standardized health, mental health, and well-being questionnaires during pregnancy at their prenatal site, and up to 12 months after delivery at their well-baby visits, when they also will complete questionnaires about their infants' development and behavior. All infants also will undergo a standardized developmental test at 12 months. Health care utilization and outcomes also will be collected through electronic medical records.
- Conditions
- Perinatal Depression, Perinatal Anxiety, Prenatal Stress
- Being tested
- Patient Navigation, Adapted Cognitive-Behavioral Therapy
- Keywords
- Postpartum depression, postpartum anxiety, pregnancy, Black women, stress, Anxiety, Depression
- Medical subject headings
- Depression, Postpartum, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigationBehavioural
Also called Maternity Care Specialist
Participants in arm 2 will receive patient navigation provided by humans (rather than e-navigation) to provide personalized care to include support, resources, and referrals to address psychosocial issues that arise during the perinatal period. Patient navigation is available to participants through 12 months postpartum.
Adapted Cognitive-Behavioral TherapyBehavioural
Also called Adapted CBT
Participants who do not meet diagnostic criteria (Group 2a) will participate in a prevention group which includes 8 sessions based on culturally adapted CBT for Black/ of African descent populations facilitated by mental health professionals. Participants who meet diagnostic criteria (Group 2b) will participate in individual treatment which includes 12 sessions based on culturally adapted CBT for Black/ of African descent populations.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants will participate in usual prenatal care throughout the duration of study. |
| Patient Navigation and treatment | Experimental | In the patient navigation arm, women who do not meet diagnostic criteria (Group 2a) can participate in: (1) group-based CBT preventative intervention; (2) peer support group (virtual); or (3) both. Women in the threshold risk group, meeting diagnostic criteria for depression/anxiety (Group 2b) at baseline can participate in: (1) individual CBT treatment (2) peer support group (virtual) (3) both
Prevention group includes 8 sessions based on culturally adapted CBT for Black/ of African descent populations facilitated by mental health professionals. Individual treatment includes 12 sessions based on culturally adapted CBT for Black/ of African descent populations. Receives: Behavioral: Patient Navigation; Behavioral: Adapted Cognitive-Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stress at 24 weeks of pregnancy to 12 months postpartum
Perceived Stress Scale: A 10-item questionnaire to measure the self-reported level of stress in the respondents by assessing feelings and thoughts during the last month. Each item is scored from 0 (never) to 5 (very often) with a range of 0 to 40 for the total score of the scale. A higher level of stress is indicated by higher scores on this scale.
Measured: Stress will be measured at 24 weeks of pregnancy through infant age of 12 months
Change in Depression at 24 weeks of pregnancy to 12 months postpartum
Edinburgh Postnatal Depression Scale: A 10-item scale used to indicate whether a parent has symptoms that are common in women with depression during pregnancy and in the year following the birth of a child. Each item is scored from 0 (As much as I ever did) to 3 (Not at all) with a range of 0 to 30. Higher level of depression is indicated by a higher score on this scale.
Measured: 2nd Obstetrics visit (assessed 24-28 weeks gestation) through 12 months postpartum
Change in Anxiety at 24 weeks of pregnancy to 12 months postpartum
General Anxiety Disorder-7 (GAD-7): A 7-item scale to measure levels of anxiety in respondents by assessing feelings and thoughts over the past 2 weeks. Each item is scored from 0 (Not at all) to 3 (Nearly every day) with a range of 0 to 21. Higher level of depression is indicated by a higher score on this scale.
Measured: 2nd Obstetrics visit (assessed 24-28 weeks gestation) through 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start22 Aug 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (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 Perinatal DepressionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Women in the patient navigator arm (Group 2a) can choose to participate in group-based preventive interventions based on: (1) a culturally adapted CBT (in person within prenatal care site or virtual given COVID); (2) peer support group (virtual); or (3) both. Women in the threshold risk group (Group 2b) at baseline warrant treatment interventions and will be invited to participate in: (1) culturally adapted CBT (individual, in person or virtual given COVID); (2) peer support (virtual); or (3) both. Women in this more severe risk group may be referred for psychiatric treatment if warranted. Randomization lists will be generated by the study statistician using a permuted block design and uploaded to a HIPAA-compliant, password-protected website (REDCap) allowing for patient randomization at the time of registration in the data collection system.
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- George Washington University, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Catherine Limperopoulos, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345834
- Sponsor's protocol ID
- Pro00015379
- Status last verified
- Jul 2025
- First submitted
- 2 Mar 2022
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Le HN, Andescavage N, Keller JM, Bassa MM, Danielson AL, Henderson D, Bond S, Mjenga N, Wells S, Quinn P, Limperopoulos C. Protocol for a randomized controlled trial of the Mommy&Me study: A multi-modal approach to address social determinants of health and mental health among low-income Black perinatal populations. Contemp Clin Trials Commun. 2025 Apr 21;45:101489. doi: 10.1016/j.conctc.2025.101489. eCollection 2025 Jun.
PubMed 40336702
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Perinatal Mental Health and Well-Being: The DC Mother-Infant Behavioral Wellness Program
- ClinicalTrials.gov ID
- NCT05345834
- Acronym / sponsor ID
- Pro00015379
- Conditions
- Perinatal Depression, Perinatal Anxiety, Prenatal Stress
- Keywords
- Postpartum depression, postpartum anxiety, pregnancy, Black women, stress, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- George Washington University, Patient-Centered Outcomes Research Institute
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 26 Apr 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.
This randomized controlled study will examine the effectiveness of patient navigation with culturally adapted cognitive-behavioral interventions and peer support groups for low-income Black/of African Descent pregnant women who are experiencing stress, anxiety, and/or depression.
Detailed description
The overarching objective is to develop and evaluate a collaborative, multi-dimensional and culturally tailored community-based model of integrated perinatal MH care. The target population is low-income Black/of African descent women with pregnancy-related stress, anxiety, and depression. There are two specific aims: (1) to refine an individualized plan to integrate patient navigation and a culturally adapted cognitive-behavioral (CBT) intervention for low-income Black/of African Descent women designed to increase recruitment and retention within the healthcare community system, and (2) through a two-arm prospective randomized controlled design, women who are subthreshold and threshold risk for prenatal stress, depression and/or anxiety will participate in one of two interventions: (a) existing prenatal intervention (usual care); or (b) patient navigation plus culturally adapted CBT, and peer support groups.
The investigators will screen 1,000 low-income pregnant AA women (18-45 years of age) in their second pregnancy visit with validated tools for stress, anxiety, and depression. A total of 700 study participants will be recruited from urban prenatal care centers in the Washington DC area and will be randomized Usual Care of Intervention conditions above (n=350/condition). Following randomization, participants will participate in a diagnostic interview based on DSM-5 criteria to 'self-select' themselves into 1 of 2 groups (i.e., 'threshold' or 'subthreshold'). Threshold includes women who meet criteria for depression or anxiety based on DSM-5 diagnostic criteria. Subthreshold includes all other women who do not meet DSM criteria). In the intervention arm, participants in the threshold group will receive a 1:1 CBT treatment intervention, and participants in the subthreshold group will receive a group CBT intervention. Both threshold groups will also include patient navigation and participation in a peer support group. Participants will complete standardized health, mental health, and well-being questionnaires during pregnancy at their prenatal site, and up to 12 months after delivery at their well-baby visits, when they also will complete questionnaires about their infants' development and behavior. All infants also will undergo a standardized developmental test at 12 months. Health care utilization and outcomes also will be collected through electronic medical records.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Women in the patient navigator arm (Group 2a) can choose to participate in group-based preventive interventions based on: (1) a culturally adapted CBT (in person within prenatal care site or virtual given COVID); (2) peer support group (virtual); or (3) both. Women in the threshold risk group (Group 2b) at baseline warrant treatment interventions and will be invited to participate in: (1) culturally adapted CBT (individual, in person or virtual given COVID); (2) peer support (virtual); or (3) both. Women in this more severe risk group may be referred for psychiatric treatment if warranted. Randomization lists will be generated by the study statistician using a permuted block design and uploaded to a HIPAA-compliant, password-protected website (REDCap) allowing for patient randomization at the time of registration in the data collection system.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants will participate in usual prenatal care throughout the duration of study. |
| Patient Navigation and treatment | Experimental | Behavioral: Patient Navigation, Behavioral: Adapted Cognitive-Behavioral TherapyIn the patient navigation arm, women who do not meet diagnostic criteria (Group 2a) can participate in: (1) group-based CBT preventative intervention; (2) peer support group (virtual); or (3) both. Women in the threshold risk group, meeting diagnostic criteria for depression/anxiety (Group 2b) at baseline can participate in: (1) individual CBT treatment (2) peer support group (virtual) (3) both Prevention group includes 8 sessions based on culturally adapted CBT for Black/ of African descent populations facilitated by mental health professionals. Individual treatment includes 12 sessions based on culturally adapted CBT for Black/ of African descent populations. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Black/of African Descent
- Pregnant (gestational weeks ≤ 28 weeks)
- Age 18-45
- English proficient
- Receiving services in 1 of 4 study sites above
Key exclusion criteria (6 listed)
- age <18
- Currently under the influence of a substance(s)
- Experiencing psychosis
- Critical (clinical) risk: actively suicidal or homicidal
- Not Black/of African Descent
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 |
|---|---|---|
| Patient NavigationAlso: Maternity Care SpecialistParticipants in arm 2 will receive patient navigation provided by humans (rather than e-navigation) to provide personalized care to include support, resources, and referrals to address psychosocial issues that arise during the perinatal period. Patient navigation is available to participants through 12 months postpartum. | Behavioural | Patient Navigation and treatment |
| Adapted Cognitive-Behavioral TherapyAlso: Adapted CBTParticipants who do not meet diagnostic criteria (Group 2a) will participate in a prevention group which includes 8 sessions based on culturally adapted CBT for Black/ of African descent populations facilitated by mental health professionals. Participants who meet diagnostic criteria (Group 2b) will participate in individual treatment which includes 12 sessions based on culturally adapted CBT for Black/ of African descent populations. | Behavioural | Patient Navigation and treatment |
Primary outcome
Change in Stress at 24 weeks of pregnancy to 12 months postpartum
Time frame: Stress will be measured at 24 weeks of pregnancy through infant age of 12 months
Perceived Stress Scale: A 10-item questionnaire to measure the self-reported level of stress in the respondents by assessing feelings and thoughts during the last month. Each item is scored from 0 (never) to 5 (very often) with a range of 0 to 40 for the total score of the scale. A higher level of stress is indicated by higher scores on this scale.
Change in Depression at 24 weeks of pregnancy to 12 months postpartum
Time frame: 2nd Obstetrics visit (assessed 24-28 weeks gestation) through 12 months postpartum
Edinburgh Postnatal Depression Scale: A 10-item scale used to indicate whether a parent has symptoms that are common in women with depression during pregnancy and in the year following the birth of a child. Each item is scored from 0 (As much as I ever did) to 3 (Not at all) with a range of 0 to 30. Higher level of depression is indicated by a higher score on this scale.
Change in Anxiety at 24 weeks of pregnancy to 12 months postpartum
Time frame: 2nd Obstetrics visit (assessed 24-28 weeks gestation) through 12 months postpartum
General Anxiety Disorder-7 (GAD-7): A 7-item scale to measure levels of anxiety in respondents by assessing feelings and thoughts over the past 2 weeks. Each item is scored from 0 (Not at all) to 3 (Nearly every day) with a range of 0 to 21. Higher level of depression is indicated by a higher score on this scale.
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 24 Jul 2025.
- Derived from this study: PubMed 40336702Le HN, Andescavage N, Keller JM, Bassa MM, Danielson AL, Henderson D, Bond S, Mjenga N, Wells S, Quinn P, Limperopoulos C. Protocol for a randomized controlled trial of the Mommy&Me study: A multi-modal approach to address social determinants of health and mental health among low-income Black perinatal populations. Contemp Clin Trials Commun. 2025 Apr 21;45:101489. doi: 10.1016/j.conctc.2025.101489. eCollection 2025 Jun.
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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 study testing Patient Navigation and Adapted Cognitive-Behavioral Therapy in people with Perinatal Depression and Perinatal Anxiety, run by Children's National Research Institute 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 8 inclusion and 6 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 24 Jul 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.
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?
Change in Stress at 24 weeks of pregnancy to 12 months postpartum (time frame: Stress will be measured at 24 weeks of pregnancy through infant age of 12 months). 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 NCT05345834, 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 24 Jul 2025; AzTrials last refreshed its copy on 26 Oct 2026.