Doula Support for Postpartum Depression

Overseen By Jessica L Liddell, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Montana

Disqualifiers: Under 18, Not pregnant, others

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

Compensation: Varies

Number of Visits: 7

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a doula (a trained birth companion) can help with postpartum depression, a condition some women experience after giving birth. Some participants will receive regular doula care, while others will have doulas specifically trained to assist with postpartum mood and anxiety disorders (PMAD). A third group will receive standard medical care without a doula. Pregnant women living in rural Montana, between their 13th and 26th weeks of pregnancy, are well-suited for this trial. As an unphased trial, this study offers a unique opportunity to enhance understanding of doula support's benefits for postpartum mental health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this doula-led intervention is safe for postpartum women?

Research has shown that having a doula, who provides support during and after pregnancy, is generally well-received. The PMAD intervention, which addresses perinatal mood and anxiety disorders, aims to prevent and manage mood and anxiety issues during this period. Studies have found that doulas trained in this area can effectively support mental health during pregnancy and after childbirth.

These interventions focus on emotional and psychological needs, and no evidence of serious side effects from this type of support exists. While the safety outlook is positive, it's important to remember that this specific intervention is still under study, and further research will help confirm these findings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for postpartum depression because it explores the effectiveness of doula support, a non-medical intervention, which is quite different from the usual treatments like antidepressants and therapy. This trial investigates how standard doula care, combined with a Perinatal Mood and Anxiety Disorders (PMAD) intervention, might provide a more holistic approach, addressing both emotional and practical needs during the postpartum period. Doulas, trained specifically to provide this PMAD care, may offer personalized support that could potentially enhance maternal mental health outcomes compared to conventional medical care alone.

What evidence suggests that this trial's treatments could be effective for postpartum depression?

Research has shown that having a doula can help reduce symptoms of postpartum depression and anxiety. In this trial, participants will be divided into different arms to evaluate the effectiveness of doula support. One arm will receive Standard Doula Care, which provides important emotional and educational help. Another arm will receive Standard Doula Care Plus the PMAD Intervention, where doulas are trained to support mental health during and after pregnancy. This additional care could further enhance mothers' well-being by focusing on mental health, meeting the emotional needs of mothers during and after pregnancy, and potentially leading to better health for both mother and child. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals over 18 years old who are currently pregnant, between 13 and 26 weeks into their pregnancy, and living in a rural area of Montana as designated by HRSA. It aims to support those facing postpartum depression (PMADs) and related mental health challenges.

Inclusion Criteria

I am over 18 years old.

Participants must live in a HRSA-designated rural area of Montana

I am currently pregnant and between 13 to 26 weeks along.

Exclusion Criteria

Participants are not currently pregnant

Participants do not live in a HRSA-designated rural area of Montana

I am not between 13-26 weeks pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive doula care throughout pregnancy, childbirth, and postpartum period

Approximately 9 months

Regular sessions with doulas

Postpartum Follow-up

Participants complete surveys and interviews at 1, 3, and 6 months postpartum to assess outcomes

6 months

Surveys at 1, 3, and 6 months postpartum

Qualitative Interviews

A subset of participants participate in qualitative interviews to discuss their experiences

6 months postpartum

Interviews at 6 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Standard Doula Care
• Standard Doula Care Plus PMAD Intervention

Trial Overview The study tests the effectiveness of standard doula care versus enhanced doula care with PMAD intervention during pregnancy, childbirth, and postpartum. One group will receive regular doula support while another gets additional PMAD-focused training; a third group receives usual perinatal care without a doula.

How Is the Trial Designed?

Group I: Standard Doula Care Plus the PMAD Intervention Experimental Treatment 1 Intervention

Participants in this arm will receive standard perinatal doula care provided by doulas trained in the DONA International doula training in addition to PMAD-specific care from their doulas.

Group II: Standard Doula Care Active Control 1 Intervention

Participants in this arm will receive standard perinatal doula care provided by doulas trained in the DONA International doula training.

Group III: Standard Maternal Care Active Control 1 Intervention

In this arm participants will receive standard perinatal medical care and will not receive care from a doula.

Who Is Running the Clinical Trial?

University of Montana

Lead Sponsor

Trials

29

Recruited

4,700+

Published Research Related to This Trial

A survey of 156 doulas and interviews with 27 doulas revealed that many felt unprepared to identify and address perinatal mood and anxiety disorders (PMADs) in their clients.

The study highlights the need for a standardized training model for postpartum doulas to better equip them in recognizing PMAD symptoms and referring women to appropriate treatment services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promotion and Prevention of Perinatal Mood and Anxiety Disorders: Doulas' Roles and Challenges. Shklarski, L., Kalogridis, L.[2023]

The study successfully recruited 39 mothers with depressive symptoms, 6 postpartum doulas, and 6 peer telephone supporters, indicating that it is feasible to conduct research on postpartum support interventions.

Mothers who received support from postpartum doulas reported higher satisfaction compared to those who received peer telephone support, suggesting that doula support may be more beneficial for mothers experiencing postpartum depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum doula and peer telephone support for postpartum depression: a pilot randomized controlled trial. Gjerdingen, DK., McGovern, P., Pratt, R., et al.[2022]

The workbook-based intervention 'What Am I Worried About?' (WAWA) effectively reduced symptoms of postpartum depression, anxiety, and stress in a small sample of 34 postpartum women, showing medium effect sizes after four weeks.

Participants who received individual phone consultations reported slightly greater reductions in postpartum depression and stress compared to those in group sessions, indicating that personalized support may enhance the intervention's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Cognitive-Behavioral Intervention for Postpartum Anxiety and Depression: Individual Phone vs. Group Format. Simhi, M., Sarid, O., Rowe, H., et al.[2021]

The MOMCare intervention significantly reduced depression severity and PTSD symptoms in socioeconomically disadvantaged women compared to the MSS-Plus program, with improvements observed from before birth to 18 months post-baseline.

Participants in the MOMCare group had higher rates of depression remission and were more likely to attend mental health visits and adhere to antidepressant treatment, indicating better quality of care and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COLLABORATIVE CARE FOR PERINATAL DEPRESSION IN SOCIOECONOMICALLY DISADVANTAGED WOMEN: A RANDOMIZED TRIAL. Grote, NK., Katon, WJ., Russo, JE., et al.[2019]

Continuous support from a trained doula during childbirth significantly shortens labor and reduces the need for interventions like cesarean deliveries and pain relief, based on evidence from 12 randomized trials.

Doula support not only improves immediate childbirth experiences but also leads to long-term benefits such as reduced postpartum depression and increased breastfeeding rates, highlighting the importance of emotional and physical support during labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The obstetrical and postpartum benefits of continuous support during childbirth. Scott, KD., Klaus, PH., Klaus, MH.[2007]

In a 6-month project involving 273 mothers, a screening protocol for postpartum depression (PPD) was successfully implemented, achieving an 83.5% screening rate during well-child visits.

Of the mothers who screened positive for PPD, 73.1% were referred to mental health services, and 63.2% attended their referral, demonstrating effective follow-up and support for those in need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multilingual Postpartum Depression Screening in Pediatric Community Health Clinics. Cohen, M., Stephens, CTD., Zaheer, A., et al.[2022]

Postpartum depression (PPD) is a common and serious condition that can be effectively identified through routine screening, such as the Edinburgh Postnatal Depression Scale, which helps improve clinical outcomes when followed by appropriate diagnostic and treatment programs.

Treatment for PPD can vary based on severity, with cognitive-behavioral therapy and interpersonal therapy recommended for mild to moderate cases, while antidepressants are suggested for more severe cases, highlighting the importance of personalized care and support systems for affected women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concise review for physicians and other clinicians: postpartum depression. Bobo, WV., Yawn, BP.[2021]

A study involving 47 maternity care practitioners revealed that while many support the role of doulas in providing emotional and physical support during childbirth, there are mixed feelings about their integration into hospital teams, often due to cultural differences between traditional medical practices and natural birth philosophies.

To improve collaboration between doulas and hospital staff, it is essential to provide training on the doula model of care, clearly define roles, and foster mutual respect, which can enhance maternal health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital-based maternity care practitioners' perceptions of doulas. Neel, K., Goldman, R., Marte, D., et al.[2020]

Postpartum depression affects 10% to 20% of women in the U.S., highlighting the need for early identification and treatment to support maternal and family health.

Individual and group psychotherapy are effective treatments for postpartum depression, and nurses play a crucial role in advising mothers on treatment options and facilitating referrals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying and treating postpartum depression. Horowitz, JA., Goodman, JH.[2022]

In a 6-week study involving 38 postpartum women, sertraline was found to significantly improve depression response rates (59% vs. 26% for placebo) and remission rates (53% vs. 21% for placebo), indicating its efficacy in treating postpartum depression (PMD).

The benefits of sertraline were particularly notable in women whose depression began within 4 weeks of childbirth, supporting the DSM-5 criteria for postpartum onset major depressive disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, placebo-controlled, double-blind trial of sertraline for postpartum depression. Hantsoo, L., Ward-O'Brien, D., Czarkowski, KA., et al.[2022]

Citations

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Home | SAMHSA - Substance Abuse and Mental Health ... SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

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Promotion and Prevention of Perinatal Mood and Anxiety ... ... standardized model for postpartum doula care that explicitly addresses PMADs. Keywords: perinatal mood and anxiety disorders (PMADs), doula, prenatal and ...

3. withpower.com withpower.com/trial/phase-depression-postpartum-2-2024-91d1d

Doula Support for Postpartum Depression This N/A medical study run by University of Montana is evaluating whether Standard Doula Care and Standard Doula Care Plus PMAD Intervention will have ...

4. jpbs.hapres.com jpbs.hapres.com/htmls/JPBS_1575_Detail.html

Disparities in Utilization and Delivery Outcomes for Women ... Perinatal mood and anxiety disorders (PMAD), which include depression and/or anxiety in the year before and/or after delivery, ...

5. qualityhealth.org qualityhealth.org/wp-content/uploads/2023/07/Maternal-Mental-Health-Evidence-Review-23-0717.docx

Maternal-Mental-Health-Evidence-Review- ... Screening for perinatal depression. ACOG Committee Opinion No. 757. American College of Obstetricians and Gynecologists. Obstet Gynecol 2018;132:e208– ...