Pilot Feasibility Study With Doulas
A Pilot Feasibility Study to Evaluate a Doula-led Postpartum Prevention Intervention
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- No age limits stated
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether doulas, who support people during and after pregnancy, can deliver the You Matter program as planned at their community clinic, MAAME, Inc. It is for people who are pregnant or gave birth within the past 3 years and have a score of 10 or higher on a depression screening tool.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Score 10 or higher on the Edinburgh Postpartum Depression screening tool.
- Are pregnant now or gave birth within the past 3 years.
Who can't join
- Are at high risk of attempting suicide very soon.
- Are currently having psychosis (trouble knowing what is real) or mania (an unusually high-energy or excited mood).
- Currently have a drug or alcohol use disorder.
- Have major health problems, such as cancer.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion criteria are: 1. Edinburgh Postpartum Depression score of 10 or greater; 2. currently pregnant or within the first 3 years postpartum. Exclusion criteria includes: 1. high risk of an imminent suicide attempt; 2. actively psychotic or manic; 3. current drug or alcohol use disorder; 4. significant health complications (e.g., cancer).
Study sites (1)
NC
- Duke University Medical Center · Durham, NC 27705Matthew Gibson · Study contact · 9196812521 · matthew.gibson646@duke.eduMore trials in Durham