EligibleTrials

Understanding the Role of Doulas in Supporting People With PMADs

Recruiting · NCT05763537 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Montana

View the official record on ClinicalTrials.gov →
Depression

Interventions studied

Standard Doula CareStandard Doula Care Plus PMAD Intervention

What this trial is about

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.

Who can take part

Age range
18 Years and older
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)

Inclusion criteria

Exclusion criteria

Where it is running

1 location listed across 1 US state.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →

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