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

Trial Summary

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 data supports the effectiveness of the treatment Standard Doula Care, Standard Doula Care Plus PMAD Intervention for postpartum depression?

Research suggests that postpartum doula support can be beneficial for at-risk mothers, and cognitive-behavioral interventions, which may be similar to the PMAD intervention, have shown effectiveness in reducing postpartum depression, anxiety, and stress. Doulas can help identify symptoms of perinatal mood and anxiety disorders, although there is a need for better training and a standardized model for addressing these issues. ^{1 2 3 4 5}

Is doula support safe for postpartum depression?

Doula support is generally considered safe for postpartum women, as it provides emotional and physical support during childbirth and the postpartum period. Studies show benefits like reduced labor pain and anxiety, and improved mood and breastfeeding rates, without indicating any safety concerns. ^{1 2 6 7 8}

How is the Doula Support for Postpartum Depression treatment different from other treatments?

This treatment is unique because it involves the support of doulas, who are trained to assist women during childbirth and the postpartum period, and includes a specific intervention for perinatal mood and anxiety disorders (PMADs). Unlike traditional treatments that may rely on medication or therapy alone, this approach combines emotional and practical support with a focus on identifying and addressing PMAD symptoms. ^{1 2 3 9 10}

What is the purpose of this trial?

Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility. Following the recruitment procedures described in the recruitment and retention plan, approximately 75 participants will be enrolled into the study. Twenty-five of the participants will receive regular doula care and 25 of the participants will receive care from a doula trained in the PMAD doula training throughout their pregnancy, childbirth, and postpartum time period, following the intervention procedures developed in Aim 2 of this study. Twenty-five women will not receive care from a doula and will receive perinatal care as usual. Women in all groups will take surveys via REDCap during their enrollment in the intervention, at 1 month postpartum, 3 months, and 6 months postpartum (at the conclusion of the intervention). All participants who receive the PMAD doula intervention will complete checklists after each session with their doula, to assess fidelity to the intervention. Participant communication with their doula via patient notebook will also be assessed for fidelity to the intervention.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Postpartum doula and peer telephone support for postpartum depression: a pilot randomized controlled trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Multilingual Postpartum Depression Screening in Pediatric Community Health Clinics. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A Cognitive-Behavioral Intervention for Postpartum Anxiety and Depression: Individual Phone vs. Group Format. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

COLLABORATIVE CARE FOR PERINATAL DEPRESSION IN SOCIOECONOMICALLY DISADVANTAGED WOMEN: A RANDOMIZED TRIAL. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

The obstetrical and postpartum benefits of continuous support during childbirth. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Hospital-based maternity care practitioners' perceptions of doulas. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Identifying and treating postpartum depression. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Concise review for physicians and other clinicians: postpartum depression. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

A randomized, placebo-controlled, double-blind trial of sertraline for postpartum depression. [2022]