Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-27 @ 9:59 PM
Study NCT ID:
NCT07217561
Status:
RECRUITING
Last Update Posted:
2025-10-22
First Post:
2025-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing "Doula Link", a Multi-Component Intervention to Improve Perinatal Mental Health
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Study Overview
Official Title:
Doula Link for Perinatal Mental Health - Trial
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Doula Link
Brief Summary:
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.
* 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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| K01MH133966 | NIH | None | https://reporter.nih.gov/quic… | View |