Doula Support for Postpartum Depression

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Montana

Disqualifiers: Under 18, Not pregnant, others

No Placebo Group

Trial Summary

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.

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}

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

I am younger than 18 years old.

Participants are not currently pregnant

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

Trial 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 (Behavioral Intervention)
• Standard Doula Care Plus PMAD Intervention (Behavioral 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Montana Missoula, MT

Who Is Running the Clinical Trial?

University of Montana Lead Sponsor

References

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

Postpartum doula and peer telephone support for postpartum depression: a pilot randomized controlled trial. [2022] This research provides the first test of feasibility of recruiting postpartum doulas and depressed mothers for a peer support intervention study and begins to evaluate the benefit of postpartum doula support and peer telephone support for at-risk mothers.

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

Promotion and Prevention of Perinatal Mood and Anxiety Disorders: Doulas' Roles and Challenges. [2023] Doulas are uniquely positioned to support women during birth and the postpartum period and can serve as a great asset to identify symptoms of perinatal mood and anxiety disorders (PMADs) and refer women to treatment. The goal of this study is to increase knowledge of doulas' training on PMADs and their work with women who experienced symptoms. Results from a survey of 156 doulas and interviews with 27 doulas indicate that they felt ill-prepared to identify PMAD symptoms. They struggled in referring patients to the appropriate services and finding professional support related to supporting clients with PMADs. The study concludes that there is a need to develop a standardized model for postpartum doula care that explicitly addresses PMADs.

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

Multilingual Postpartum Depression Screening in Pediatric Community Health Clinics. [2022] This evidence-based practice project established postpartum depression (PPD) screening and followed maternal use of mental health services in a multilingual low socioeconomic status urban population.

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

A Cognitive-Behavioral Intervention for Postpartum Anxiety and Depression: Individual Phone vs. Group Format. [2021] Cognitive-behavioral interventions can effectively treat symptoms of perinatal mood and anxiety disorders (PMADs). We assessed the acceptability and effectiveness of a workbook-based intervention (What Am I Worried About? (WAWA)) comprising of cognitive-behavioral and mindfulness techniques and weekly professional guidance to address symptoms of depression, anxiety, and stress among postpartum mothers. We compared the efficacy of group versus individual telephone consultation using a pre-and post-test single group, open trial, research design in replication pilot study. A convenience sample of community-residing postpartum women (n = 34) chose between group intervention (n = 24) or individual phone consultation with a mental health professional (n = 10). Outcome measures were anxiety (GAD-7), depression, anxiety, and stress (DASS21), and postpartum depression (PPD-EPDS). After four weeks intervention, significant reductions were observed in postpartum depression, anxiety, and stress scales. Cohen's d statistics showed medium effect sizes (0.35-0.56). A small but significantly larger change in PPD-EPDS and DASS stress scores was reported among participants who opted for the phone intervention compared to those in the group intervention. Most participants felt that the intervention was highly beneficial and would recommend it to other postpartum women. In conclusion, the WAWA intervention showed efficacy for reducing postpartum anxiety, distress, and depressive symptoms among postpartum women, with a slightly greater reduction in PPD-EPDS and stress symptoms found among those who opted for individual phone consultation. Definitive evaluation of the intervention requires a larger sample and a RCT research design with two treatment arms: telephone and group intervention.

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

COLLABORATIVE CARE FOR PERINATAL DEPRESSION IN SOCIOECONOMICALLY DISADVANTAGED WOMEN: A RANDOMIZED TRIAL. [2019] Both antenatal and postpartum depression have adverse, lasting effects on maternal and child well-being. Socioeconomically disadvantaged women are at increased risk for perinatal depression and have experienced difficulty accessing evidence-based depression care. The authors evaluated whether "MOMCare,"a culturally relevant, collaborative care intervention, providing a choice of brief interpersonal psychotherapy and/or antidepressants, is associated with improved quality of care and depressive outcomes compared to intensive public health Maternity Support Services (MSS-Plus).

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

The obstetrical and postpartum benefits of continuous support during childbirth. [2007] The purpose of this article is to review the evidence regarding the effectiveness of continuous support provided by a trained laywoman (doula) during childbirth on obstetrical and postpartum outcomes. Twelve individual randomized trials have compared obstetrical and postpartum outcomes between doula-supported women and women who did not receive doula support during childbirth. Three meta-analyses, which used different approaches, have been performed on the results of the clinical trials. Emotional and physical support significantly shortens labor and decreases the need for cesarean deliveries, forceps and vacuum extraction, oxytocin augmentation, and analgesia. Doula-supported mothers also rate childbirth as less difficult and painful than do women not supported by a doula. Labor support by fathers does not appear to produce similar obstetrical benefits. Eight of the 12 trials report early or late psychosocial benefits of doula support. Early benefits include reductions in state anxiety scores, positive feelings about the birth experience, and increased rates of breastfeeding initiation. Later postpartum benefits include decreased symptoms of depression, improved self-esteem, exclusive breastfeeding, and increased sensitivity of the mother to her child's needs. The results of these 12 trials strongly suggest that doula support is an essential component of childbirth. A thorough reorganization of current birth practices is in order to ensure that every woman has access to continuous emotional and physical support during labor.

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

Hospital-based maternity care practitioners' perceptions of doulas. [2020] A birth doula provides continuous informational, physical, and emotional support during pregnancy, labor, and immediately postpartum. Existing data on the benefits of doulas, especially for low-resource, high-need patients, do not address how and why individual practitioners decide to recommend this model of care. This project aims to describe best practices of integrating doulas into hospital-based maternity care teams to facilitate access to this evidence-based service for improving maternal health outcomes.

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

Identifying and treating postpartum depression. [2022] Postpartum depression affects 10% to 20% of women in the United States and negatively influences maternal, infant, and family health. Assessment of risk factors and depression symptoms is needed to identify women at risk for postpartum depression for early referral and treatment. Individual and group psychotherapy have demonstrated efficacy as treatments, and some complementary/alternative therapies show promise. Treatment considerations include severity of depression, whether a mother is breastfeeding, and mother's preference. Nurses who work with childbearing women can advise depressed mothers regarding treatment options, make appropriate recommendations, provide timely and accessible referrals, and encourage engagement in treatment.

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

Concise review for physicians and other clinicians: postpartum depression. [2021] Postpartum depression (PPD) is a common, potentially disabling, and, in some cases, life-threatening condition. Fortunately, PPD is also readily detectable in routine practice and is amenable to treatment by a wide variety of modalities that are effective for treating nonpuerperal major depression. Postpartum depression screening can improve case identification (an Edinburgh Postnatal Depression Scale score of ≥ 13 indicates a high risk of PPD) and, when associated with a diagnostic and follow-up program, leads to improved clinical outcomes. Symptom severity, patient preference, past response to treatment, availability of local mental health care resources, and patient decisions about breast-feeding will drive management decisions. In general, cognitive-behavioral therapy and interpersonal therapy are preferred psychotherapies for women with mild to moderate PPD, whereas antidepressants are appropriate in more severe cases. Many patients will require other types of assistance, such as parenting support, case management, or care coordination because many barriers to receiving adequate PPD treatment must still be overcome.

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

A randomized, placebo-controlled, double-blind trial of sertraline for postpartum depression. [2022] Postpartum depression (PMD) occurs in roughly 10 % of postpartum women and negatively impacts the mother and her offspring, but there are few placebo-controlled studies of antidepressant treatment in this population.