75 Participants Needed

Doula Support for Postpartum Depression

JL
Overseen ByJessica L Liddell, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Montana
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.12678

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.123910

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
3Treatment groups
Experimental Treatment
Active Control
Group I: Standard Doula Care Plus the PMAD InterventionExperimental Treatment1 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 CareActive Control1 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 CareActive Control1 Intervention
In this arm participants will receive standard perinatal medical care and will not receive care from a doula.

Find a Clinic Near You

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

References

Postpartum doula and peer telephone support for postpartum depression: a pilot randomized controlled trial. [2022]
Promotion and Prevention of Perinatal Mood and Anxiety Disorders: Doulas' Roles and Challenges. [2023]
Multilingual Postpartum Depression Screening in Pediatric Community Health Clinics. [2022]
A Cognitive-Behavioral Intervention for Postpartum Anxiety and Depression: Individual Phone vs. Group Format. [2021]
COLLABORATIVE CARE FOR PERINATAL DEPRESSION IN SOCIOECONOMICALLY DISADVANTAGED WOMEN: A RANDOMIZED TRIAL. [2019]
The obstetrical and postpartum benefits of continuous support during childbirth. [2007]
Hospital-based maternity care practitioners' perceptions of doulas. [2020]
Identifying and treating postpartum depression. [2022]
Concise review for physicians and other clinicians: postpartum depression. [2021]
A randomized, placebo-controlled, double-blind trial of sertraline for postpartum depression. [2022]
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