Doula Link: training doulas to support perinatal mental health
Doula Link for Perinatal Mental Health - Trial
This test will see if training doulas with the Doula Link program helps pregnant and postpartum people with depression or anxiety.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07217561 on ClinicalTrials.gov |
What this trial studies
Doula Link is a multi-component program that trains doulas to provide direct support for perinatal mental health using a tailored mental health toolkit, an evidence-based stress-reduction program (Our Babies and Us), and access to psychiatric consultation through MCPAP for Moms. In this randomized pilot, doulas are assigned to receive Doula Link training and supports or to continue their usual practice, and their clients are followed to measure feasibility, acceptability, and early differences in depression and anxiety. The study collects data on implementation outcomes and preliminary client mood and anxiety symptoms in the postpartum period. Results will inform whether a larger trial is warranted and how to scale doula-led mental health support.
Who should consider this trial
Good fit: Ideal candidates are pregnant people or those within 12 weeks postpartum who are served by participating doulas, live and plan to give birth in Massachusetts, and speak English or Spanish, and doulas currently providing prenatal or postpartum support in Massachusetts who can attend in-person training.
Not a fit: People beyond 12 weeks postpartum, those not served by the study’s participating doulas, those living outside Massachusetts, or individuals with severe psychiatric conditions requiring specialized psychiatric care may not benefit from this intervention.
Why it matters
Potential benefit: If successful, Doula Link could help doulas identify and address perinatal depression and anxiety earlier and connect more families to mental health care, reducing symptoms and improving postpartum well-being.
How similar studies have performed: Previous research shows doulas can improve birth and postpartum outcomes and separate perinatal mental health programs can reduce symptoms, but this specific combination of doula training plus psychiatric consultation is relatively novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * For doulas: currently providing prenatal or postpartum support to at least one client; plant to provide prenatal or postpartum support to at least three clients in the next six months; work in Massachusetts; did not participate in development of the intervention; available to participate in in-person training; English language fluency * For clients: Pregnant or no more than 12 weeks postpartum at enrollment; served by one of the 30 study doulas; live in, and plan to give birth in Massachusetts; fluency in either English or Spanish Exclusion Criteria: * Not meeting inclusion criteria
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Elysia Larson
- Email: elarson@bidmc.harvard.edu
- Phone: 617-667-4051
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.