An interventional study of Doula Link in Perinatal Depression and Perinatal Anxiety, sponsored by Beth Israel Deaconess Medical Center. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-10-22.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Health services research
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:
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.
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:
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.
8,057 studies on the registry are indexed under Depression; 1,643 are open to participants now.
This study's planned enrollment of 90 is close to the median of 84 across 6,718 interventional studies indexed under Depression.
Browse Depression studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Behavioral: Doula Link
Doulas randomized to this arm will continue to provide care as usual
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
Acceptability of Intervention Measure
Perception among postpartum individuals in the Doula Link arm that Doula Link is agreeable and perception among postpartum individuals in the Doula Link arm that Doula Link and its individual components is agreeable. The "Acceptability of Intervention Measure (AIM) will be used. This is a four-question scale scored on a range from 1-5 with higher values indicating better acceptability.
Time frame: 32-weeks gestation and 6 weeks postpartum postpartum for clients. Directly following, 6-months after, and 12-months after training for doulas.
Feasibility of Intervention
How well Doula Link and its individual components can be successfully delivered to doulas. The "Feasibility of Intervention Measure" (FIM) will be used. This is a four-question scale scored on a range from 1-5 with higher values indicating better feasibility.
Time frame: Directly following, 6-months after, and 12-months after doula training
Appropriateness of Intervention
The perceived fit and relevance of Doula Link and its individual components among doulas and their clients in the Doula Link arm. The "Appropriateness of Intervention Measure" (IAM) will be used. This is a four-question scale scored on a range from 1-5 with higher values indicating better appropriateness.
Time frame: 32-weeks gestation and 6 weeks postpartum for clients. Directly following, 6-months after, and 12-months after training for doulas.
Fidelity of implementation of Our Babies and Us
The degree to which the Our Babies and Us component of Doula Link is implemented by the doulas to each client. This will be measured using the Our Babies and Us fidelity scale, which measures each topic across three dimensions. Possible scores range from 0 to 6 with higher scores indicating higher fidelity.
Time frame: Every two weeks after client enrollment for a total of six time points.
Reach of Our Babies and Us component
The proportion of clients who receive part or all of the Our Babies and Us component of the intervention.
Time frame: At 6 weeks postpartum
Symptoms of depression
Client scores on the Edinburgh Postnatal Depression Scale (EPDS). Possible range of scores is 0 to 30 with higher scores indicating a worse outcome.
Time frame: 32-weeks gestation, 6-weeks postpartum, and 16-weeks postpartum
Symptoms of anxiety
Symptoms of anxiety as measured by the generalized anxiety scale (GAD-7). The possible range of scores is 0 to 21 with higher scores indicating a worse outcome.
Time frame: 32-weeks gestation and 6- and 16-weeks postpartum
Feasibility of Our Babies and Us
How well doulas can implement the our Babies and Us component to their clients. The "Feasibility of Intervention Measure" (FIM) will be used. This is a four-question scale scored on a range from 1-5 with higher values indicating better feasibility.
Time frame: Directly following, 6-months after, and 12-months after doula training
Reach of MCPAP for Moms component
The proportion of doulas who call to access the MCPAP for Moms component of the intervention.
Time frame: At the completion of the doula intervention
Help-seeking
Clients scores on the barriers to access to care evaluation scale (BACE). The possible range of scores on the BACE is 0 to 90 with higher scores indicating a worse outcome, i.e. more barriers to access to care.
Time frame: 32-weeks gestation and 6- and 16-weeks postpartum
Treatment participation
Proportion of individuals who have symptoms of depression (denominator) who report accessing treatment (numerator) in the past six weeks. Denominator is defined as a score of 10 or higher on the Edinburgh Postpartum Depression Scale (EPDS), indicating any thoughts of self-harm on the EPDS, or having been diagnosed with depression by a clinician. Numerator is defined as having seen a mental health professional or been prescribed medication to treat a perinatal mental health disorder.
Time frame: 32-weeks gestation and 6- and 16-weeks postpartum
Skills used
Our babies and us stress reduction skill used. The "Mothers and Babies Skills Utilization Scale" will be used. This 11-item scale assesses aspects of skills using a five-point frequency Likert scale. The full scale has a possible range of 0 to 44 with higher scores indicating a better outcome, i.e. more skills used.
Time frame: 32-weeks gestation, 6-weeks postpartum, and 16-weeks postpartum
Plan to share: No — Per institutional policy, IPD cannot be shared with other researchers without a formal data use agreement.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Beth Israel Deaconess Medical Center