Testing "Doula Link", a Multi-Component Intervention to Improve Perinatal Mental Health
NCT ID: NCT07217561
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2025-10-21
2027-06-30
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Doula Link
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
Doula Link
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 Support as Usual
Doulas randomized to this arm will continue to provide care as usual
No interventions assigned to this group
Interventions
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Doula Link
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
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Elysia Larson
Principal Investigator
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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BIDMC2023P000426
Identifier Type: -
Identifier Source: org_study_id
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