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NCT05763537 · ClinicalTrials.gov registry record · NA
Understanding the Role of Doulas in Supporting People With PMADs
A NA study of Depression and Pregnancy, sponsored by University of Montana.
- Recruiting
- Registry status
- NA
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT05763537: Recruiting NA study of Depression and Pregnancy, sponsored by University of Montana.
NCT05763537 is a NA study of Depression and Pregnancy that is actively recruiting participants, run by University of Montana. The registered enrollment target is 75 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05763537, a NA study of Depression and Pregnancy, is actively recruiting participants, sponsored by University of Montana.
- RECRUITING
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
The Childbirth Self-Efficacy Inventory (CBSEI) is a 60-item self-report instrument that measures self-efficacy expectancies for coping with childbirth. In describing the development of the CBSEI, Lowe (1993) reports that the CBSEI scales have excellent internal consistency reliability (0.86 to 0.96) and factor analysis suggested that each CBSEl scale is unidimensional. Validity of the CBSEI was supported by significant positive correlations with the criterion variables of generalized self-effica
Conditions Studied
Interventions
- BEHAVIORAL Standard Doula Care Plus PMAD Intervention
- BEHAVIORAL Standard Doula Care
Study Locations (1)
Montana
- University of Montana - Missoula
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2024-11-26 |
| Est. Completion | 2026-07-31 |
| Phase | NA |
What NCT05763537 shows while recruiting
NCT05763537 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (90% lower).
The record links to 10 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Standard Doula Care Plus PMAD Intervention is the first listed.
NCT05763537 reports a single indexed study location in Montana.
Frequently Asked Questions
What is clinical trial NCT05763537 about?
NCT05763537 is a clinical study titled "Understanding the Role of Doulas in Supporting People With PMADs". 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 t...
What is the current status of trial NCT05763537?
This trial is currently recruiting. It is a NA study. The enrollment target is 75 participants. The study started on 2024-11-26. Estimated completion is 2026-07-31.
What conditions does trial NCT05763537 study?
This clinical trial studies the following conditions: Depression, Pregnancy, Substance-Related Disorders, Mental Health, Postpartum Depression.
What interventions are being tested in trial NCT05763537?
The interventions under investigation include: Standard Doula Care Plus PMAD Intervention (BEHAVIORAL), Standard Doula Care (BEHAVIORAL).
Who is sponsoring clinical trial NCT05763537?
This trial is sponsored by University of Montana, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05763537 being conducted?
This trial has 1 study location across Montana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05763537's enrollment target sits among peer trials
75 387th of 679 higher than 288 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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