Doula Link for Perinatal Mental Health

(Doula Link Trial)

Overseen By Elysia Larson

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Not meeting inclusion criteria

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new program, "Doula Link," can enhance the support doulas provide to new and expecting parents regarding mental health. It will compare doulas using Doula Link—which includes specialized training and tools for mental health support—to those continuing their standard practices. The study examines how this new approach might affect feelings of depression and anxiety in postpartum individuals. Ideal candidates are pregnant or recently postpartum individuals in Massachusetts who are already working with a participating doula. As an unphased trial, this study offers a unique opportunity to contribute to innovative mental health support methods for new parents.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on the support provided by doulas rather than medication use.

What prior data suggests that the Doula Link intervention is safe and feasible?

Research has shown that doulas are generally safe and play an important role in improving maternal health. They offer emotional and physical support, which can reduce the risk of negative health outcomes. In a previous study, doulas helped lower the number of adverse events in mothers, especially those facing specific social or medical challenges.

The "Doula Link" program provides new tools and training for doulas to support mental health. This includes access to mental health experts and a stress-reduction program called "Our Babies and Us." While direct safety data for "Doula Link" itself is not available, the new elements mainly involve training and access to resources, which are unlikely to cause harm. The goal is to enhance doulas' ability to support mental health, not to introduce new medical treatments.

Overall, "Doula Link" builds on the safety of traditional doula care by improving their capacity to support mental health. No reports of safety concerns have emerged from these new elements, suggesting that "Doula Link" is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Doula Link program because it provides a fresh approach to perinatal mental health by integrating specialized mental health support into traditional doula services. Unlike standard care, which typically involves general doula support or referrals to mental health professionals, Doula Link equips doulas with a mental health toolkit and trains them to implement a stress-reduction program specifically designed for new parents. Additionally, doulas in this program receive expert consultations with perinatal psychiatric specialists, offering a comprehensive, hands-on support system that is not commonly available. This integrated support aims to address mental health proactively, paving the way for potentially better outcomes for new mothers.

What evidence suggests that Doula Link could be effective for improving perinatal mental health?

Research has shown that doulas can improve mental health for pregnant and new mothers by offering emotional support and connecting them to mental health services. Studies have found that doulas often form strong, supportive bonds with their clients, benefiting mental health. In this trial, the Doula Link program, one of the study arms, adds extra training and resources, such as stress-reduction programs and expert advice, to enhance these benefits. Although specific data on Doula Link's effectiveness is not yet available, its components are based on methods that have shown promise in supporting mental health during and after pregnancy. Early results suggest that this approach could help reduce depression and anxiety in new mothers. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for pregnant and postpartum individuals experiencing depression or anxiety. Doulas who support these clients can also participate. The study excludes those who may not be able to complete surveys or follow the intervention protocol.

Inclusion Criteria

I am a doula in Massachusetts, supporting clients and can attend training in English.

I am pregnant or within 12 weeks after giving birth, live in Massachusetts, and speak English or Spanish.

Exclusion Criteria

Not meeting inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Doulas receive training on mental health, the 'Our Babies and Us' program, and access to consultations with perinatal psychiatric specialists.

Directly following, 6-months after, and 12-months after training

Intervention

Doulas implement the Doula Link intervention, including the use of a mental health toolkit and support groups.

32-weeks gestation to 6 weeks postpartum

Follow-up

Participants are monitored for mental health outcomes and intervention effectiveness.

16 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Doula Link

Trial Overview 'Doula Link' is being tested against standard doula practices to see if it improves mental health in new parents. It includes special training, tools, access to psychiatrists, referral specialists, and a support group for doulas.

How Is the Trial Designed?

Group I: Doula Link Experimental Treatment 1 Intervention

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

Group II: Doula Support as Usual Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07217561

NCT07217561 | Testing "Doula Link", a Multi-Component ... Their support has been shown to improve health outcomes for pregnant and postpartum individuals. This study will pilot test a multi-component intervention, ...

2. reporter.nih.gov reporter.nih.gov/project-details/10723985

Project Details The proposed research will work with doulas, perinatal people, and clinicians to co-develop and pilot test a multi- component intervention called “Doula Link ...

3. trialx.com trialx.com/clinical-trials/listings/325206/testing-doula-link-a-multi-component-intervention-to-improve-perinatal-mental-health/

Testing "Doula Link", a Multi-Component Intervention to ... Researchers will compare "Doula Link" to usual doula practice to see if Doula Link is feasible and has potential to improve mental health ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2949856225000297

A qualitative study of doulas providing emotional support ... Participants reported two main ways doulas can and do support perinatal mental health: first, by acting as a bridge to mental health services and resources, and ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1272513/full

The role of doulas in supporting perinatal mental health Results: Doulas and clients reported positive relationships, supported by congruence in culture, language, and lived experiences. Doulas varied ...

6. saferbirth.org saferbirth.org/psbs/perinatal-mental-health-conditions/

Perinatal Mental Health Conditions | AIM Perinatal mental health conditions refer to mood, anxiety, and anxiety-related disorders that occur during pregnancy or within one year of delivery.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9257331/

Doula care across the maternity care continuum and impact ... Evidence collectively suggests that doulas can decrease risk of adverse maternal health outcomes, particularly among women whose sociodemographic and clinical ...