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

NCT07217561 | Recruiting DMC

• 2 other identifiers: BIDMC2023P000426K01MH133966
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Depression; Perinatal Anxiety

Keywords

Doulas; Perinatal mental health; Depression

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (7)

• Appropriateness of Intervention

  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

  Every two weeks after client enrollment for a total of six time points.

• Reach of Our Babies and Us component

  At 6 weeks postpartum

• Symptoms of depression

  32-weeks gestation, 6-weeks postpartum, and 16-weeks postpartum

• Symptoms of anxiety

  32-weeks gestation and 6- and 16-weeks postpartum

Other Outcomes (3)

• Help-seeking

  32-weeks gestation and 6- and 16-weeks postpartum

• Treatment participation

  32-weeks gestation and 6- and 16-weeks postpartum

• Skills used

  32-weeks gestation, 6-weeks postpartum, and 16-weeks postpartum

Study Arms (2)

Doula Link

EXPERIMENTAL

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

Doula Support as Usual

NO INTERVENTION

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

Interventions

Doula Link BEHAVIORAL

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

Doula Link

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (12)

• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

  PMID: 28851459 BACKGROUND

• Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.

  PMID: 20957426 BACKGROUND

• Larson E. Cornely RM, Gebel C, Falade E, Ezekwesili C, Peprah-Wilson S, Dodge LE, Julce C, Byatt N. A qualitative study of doulas providing emotional support during the perinatal period: an unharnessed opportunity in the United States. SSM-Health Systems 2025;4. doi: 10.1016/j.ssmhs.2025.100077

  BACKGROUND

• Bohren MA, Hofmeyr GJ, Sakala C, Fukuzawa RK, Cuthbert A. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2017 Jul 6;7(7):CD003766. doi: 10.1002/14651858.CD003766.pub6.

  PMID: 28681500 BACKGROUND

• Byatt N, Biebel K, Moore Simas TA, Sarvet B, Ravech M, Allison J, Straus J. Improving perinatal depression care: the Massachusetts Child Psychiatry Access Project for Moms. Gen Hosp Psychiatry. 2016 May-Jun;40:12-7. doi: 10.1016/j.genhosppsych.2016.03.002. Epub 2016 Mar 21.

  PMID: 27079616 BACKGROUND

• Tandon SD, Ward EA, Hamil JL, Jimenez C, Carter M. Perinatal depression prevention through home visitation: a cluster randomized trial of mothers and babies 1-on-1. J Behav Med. 2018 Oct;41(5):641-652. doi: 10.1007/s10865-018-9934-7. Epub 2018 May 15.

  PMID: 29766470 BACKGROUND

• Singla DR, Lawson A, Kohrt BA, Jung JW, Meng Z, Ratjen C, Zahedi N, Dennis CL, Patel V. Implementation and Effectiveness of Nonspecialist-Delivered Interventions for Perinatal Mental Health in High-Income Countries: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2021 May 1;78(5):498-509. doi: 10.1001/jamapsychiatry.2020.4556.

  PMID: 33533904 BACKGROUND

• Dennis CL, Chung-Lee L. Postpartum depression help-seeking barriers and maternal treatment preferences: a qualitative systematic review. Birth. 2006 Dec;33(4):323-31. doi: 10.1111/j.1523-536X.2006.00130.x.

  PMID: 17150072 BACKGROUND

• Byatt N, Xiao RS, Dinh KH, Waring ME. Mental health care use in relation to depressive symptoms among pregnant women in the USA. Arch Womens Ment Health. 2016 Feb;19(1):187-91. doi: 10.1007/s00737-015-0524-1. Epub 2015 Apr 7.

  PMID: 25846018 BACKGROUND

• O'Connor E, Senger CA, Henninger ML, Coppola E, Gaynes BN. Interventions to Prevent Perinatal Depression: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2019 Feb 12;321(6):588-601. doi: 10.1001/jama.2018.20865.

  PMID: 30747970 BACKGROUND

• Dennis CL, Falah-Hassani K, Shiri R. Prevalence of antenatal and postnatal anxiety: systematic review and meta-analysis. Br J Psychiatry. 2017 May;210(5):315-323. doi: 10.1192/bjp.bp.116.187179. Epub 2017 Mar 16.

  PMID: 28302701 BACKGROUND

• Bennett HA, Einarson A, Taddio A, Koren G, Einarson TR. Prevalence of depression during pregnancy: systematic review. Obstet Gynecol. 2004 Apr;103(4):698-709. doi: 10.1097/01.AOG.0000116689.75396.5f.

  PMID: 15051562 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Elysia Larson

CONTACT

617-667-4051; elarson@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2025
• First Posted: October 16, 2025
• Study Start: October 21, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)