Post PartumNCT07614789
Pilot Feasibility Study With Doulas
A study testing YouMatter in people with Post Partum and Maternal Depression, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether an existing evidence-based intervention, You Matter, can be delivered with fidelity by doulas at their community clinic, MAAME, Inc. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Post Partum, Maternal Depression, Maternal Depression and Parent Practices, Postpartum
- What is being tested?
- YouMatter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Dec 2027
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Edinburgh Postpartum Depression score of 10 or greater;
- currently pregnant or within the first 3 years postpartum.
Who cannot join
- high risk of an imminent suicide attempt;
- actively psychotic or manic;
- current drug or alcohol use disorder;
- significant health complications (e.g., cancer).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
Matthew Gibson, 9196812521, matthew.gibson646@duke.edu
About this study
Official title: A Pilot Feasibility Study to Evaluate a Doula-led Postpartum Prevention Intervention
The purpose of this study is to determine whether an existing evidence-based intervention, You Matter, can be delivered with fidelity by doulas at their community clinic, MAAME, Inc.
Read the detailed description
The purpose of this study is to determine whether an existing evidence-based intervention, You Matter, can be delivered with fidelity by doulas at their community clinic, MAAME, Inc. The researchers will: (1) train doulas to implement You Matter; (2) recruit 40 pregnant and postpartum women to participate in You Matter; (3) evaluate whether You Matter reduced postpartum depression and trauma symptoms.
- Being tested
- YouMatter
- Keywords
- Post Partum, maternal depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YouMatterBehavioural
You Matter is an 8-week, 8-session (8 group sessions) intervention that integrates mental health and parenting psychoeducation, supports parent-child interactions, enhances social connections, provides access to culturally-relevant resources, and emphasizes emotional and physical self-care
| Study group | Role | What they receive |
|---|---|---|
| You Matter Intervention | Experimental | Receive the YouMatter intervention. Receives: Behavioral: YouMatter |
What is being measured
The primary outcome is the main question the study is designed to answer.
You Matter Intervention Fidelity
The percentage of content of the You Matter Intervention that were accurately delivered (yes/no) across providers as determined by rater's assessment of recorded sessions.
Measured: 8 weeks
Secondary outcomes (2)
Change in PTSD Checklist for DSM-5 (PCL-5)
A 20 item questionnaire with a 5 point Likert -scale ranging from not at all to extremely. Lower scores indicate better outcomes; Min score: 0; Max score: 80
Measured: 8 weeks
Change in Edinburgh Postnatal Depression Scale (EPDS)
A 10-item questionnaire on a 4-point Likert scale. Lower score indicates better outcome; Min score: 0; Max score: 30
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post PartumStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614789
- Sponsor's protocol ID
- Pro00119143
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study to Evaluate a Doula-led Postpartum Prevention Intervention
- ClinicalTrials.gov ID
- NCT07614789
- Acronym / sponsor ID
- Pro00119143
- Keywords
- Post Partum, maternal depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 May 2026 (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.
The purpose of this study is to determine whether an existing evidence-based intervention, You Matter, can be delivered with fidelity by doulas at their community clinic, MAAME, Inc.
Detailed description
The purpose of this study is to determine whether an existing evidence-based intervention, You Matter, can be delivered with fidelity by doulas at their community clinic, MAAME, Inc. The researchers will: (1) train doulas to implement You Matter; (2) recruit 40 pregnant and postpartum women to participate in You Matter; (3) evaluate whether You Matter reduced postpartum depression and trauma symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| You Matter Intervention | Experimental | Behavioral: YouMatterReceive the YouMatter intervention. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Edinburgh Postpartum Depression score of 10 or greater;
- currently pregnant or within the first 3 years postpartum.
Key exclusion criteria (4 listed)
- high risk of an imminent suicide attempt;
- actively psychotic or manic;
- current drug or alcohol use disorder;
- significant health complications (e.g., cancer).
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 |
|---|---|---|
| YouMatterYou Matter is an 8-week, 8-session (8 group sessions) intervention that integrates mental health and parenting psychoeducation, supports parent-child interactions, enhances social connections, provides access to culturally-relevant resources, and emphasizes emotional and physical self-care | Behavioural | You Matter Intervention |
Primary outcome
You Matter Intervention Fidelity
Time frame: 8 weeks
The percentage of content of the You Matter Intervention that were accurately delivered (yes/no) across providers as determined by rater's assessment of recorded sessions.
2 secondary outcomes
Change in PTSD Checklist for DSM-5 (PCL-5)
Time frame: 8 weeks
Change in Edinburgh Postnatal Depression Scale (EPDS)
Time frame: 8 weeks
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 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YouMatter in people with Post Partum and Maternal Depression, run by Duke University 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 2 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: opening soon, as of the sponsor's last update on 5 Aug 2026. 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?
Contact Liz Conradt, Ph.D. (9196812521, liz.conradt@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
You Matter Intervention Fidelity (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2026.