Testing "Doula Link", a Multi-Component Intervention to Improve Perinatal Mental Health

Beth Israel Lahey Health

Status: Enrolling

Conditions: Perinatal Depression; Perinatal Anxiety

Treatments: Behavioral: Doula Link

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07217561

K01MH133966 (U.S. NIH Grant/Contract)

BIDMC2023P000426

Details and patient eligibility

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.

Full description

Many people experience anxiety, depression, or other mental health concerns during the pregnancy, birth, and the postpartum periods. Despite interventions that work to prevent and treat, most perinatal depression and anxiety is unprevented and untreated. Doulas are trained professionals who offer emotional, educational, and physical support during this period. Their support has been shown to improve health outcomes for pregnant and postpartum individuals.

This study will pilot test a multi-component intervention, called Doula Link for Perinatal Mental Health (Doula Link), that gives doulas the tools to directly support mental health. Through Doula Link, doulas will receive:

1. a doula-specific mental health toolkit adapted from MCPAP for Moms, a statewide psychiatry access program;
2. training to implement an evidence-based, stress-reduction program called Our Babies and Us;
3. access to expert consultations and client referrals with perinatal psychiatric specialists through MCPAP for Moms.
4. training on perinatal mental health
5. access to doula support groups

By bringing together clinicians, doulas, and families, the goal of Doula Link is to support doulas to support their clients' mental health. Investigators hypothesize that building a program with doulas to provide direct support and link health system and community resources is an attainable intervention to expand access to mental health support.

Enrollment: 90 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Doula Link

Experimental group

Description:

Doulas randomized to this arm will receive: 1) a doula-specific mental health toolkit; 2) training to implement an evidence-based, stress-reduction program called Our Babies and Us; 3) training for, and access to expert consultations with perinatal psychiatric specialists through MCPAP for Moms; 4) training on perinatal mental health; 5) access to doula support groups

Treatment:

Behavioral: Doula Link

Doula Support as Usual

No Intervention group

Description:

Doulas randomized to this arm will continue to provide care as usual