Testing "Doula Link", a Multi-Component Intervention to Improve Perinatal Mental Health
Beth Israel Deaconess Medical Center · with National Institute of Mental Health (NIMH) · NCT07217561
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Any age listed · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 90
- US sites recruiting
- 1
- Study start
- October 21, 2025
- Record last updated
- October 22, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
Doulas are trained individuals who offer informational, emotional, and physical support to their pregnant, birthing, and postpartum clients. The goal of this clinical trial is to learn if a new intervention (called "Doula Link") is feasible to implement and acceptable to both doulas and their clients. The main questions it aims to answer are:
- Is Doula Link feasible to implement and acceptable to doulas and their clients?
- What are the preliminary differences in depression and anxiety between individuals working with doulas who received Doula Link compared to those who did not receive Doula Link?
Researchers will compare "Doula Link" to usual doula practice to see if Doula Link is feasible and has potential to improve mental health outcomes in postpartum individuals.
Doulas will be randomly assigned to either receive "Doula Link" or continue with their practice as usual.
Participating doulas assigned to Doula Link will receive training mental health and implementing an intervention called "Our Babies and Us"; receive access to a toolkit; receive access to perinatal psychiatrists and referral specialists for consultations; receive access to a support group
All participating doulas will be invited to complete surveys about their experience with Doula Link (if assigned to that group) and their experience providing care for their clients.
All participating clients (pregnant and postpartum individuals) will be invited to complete surveys about their experiences with their doulas, their own mental health, and their experiences with the health system.
Being studied: Doula Link
Conditions: Perinatal Depression; Perinatal Anxiety
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Beth Israel Deaconess Medical Center
Boston, MA 02215
Site contact: Elysia Larson · 6173655776 · elarson@bidmc.harvard.edu
Study contacts (from the official record)
- Elysia Larson · 617-667-4051 · elarson@bidmc.harvard.edu
Similar studies in Massachusetts
All mental health studies in Massachusetts →- RecruitingPhase 1/Phase 2Overnight stay mentioned
A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Subjects With Bipolar I Disorder
Alzamend Neuro, Inc.
- Location
- Boston, MA
- Eligibility basics
- Ages 18–65
- RecruitingHealthy volunteersPhase 1/Phase 2
PET Brain Imaging in Multiple Sclerosis, Alzheimer's Disease, and Other Neurological and Neuropsychiatric Diseases
Brigham and Women's Hospital
- Location
- Boston, MA
- Eligibility basics
- Ages 18–85
- RecruitingHealthy volunteers
Observational Study of Decentralized Urine Optical Interaction Patterns Associated With Environmental Microplastic and Nanoplastic Exposure
Ecotera Health LLC
- Location
- Boston, MA + 50 other US sites
- Eligibility basics
- Ages 18+
- RecruitingHealthy volunteersPhase 3
REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool
Senseye, Inc.
- Location
- Boston, MA + 2 other US sites
- Eligibility basics
- Ages 18+