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NCT04846504 · ClinicalTrials.gov registry record · NA
Accelerating Implementation of Mindful Mood Balance for Moms
A NA study, sponsored by Kaiser Permanente.
- Completed
- Registry status
- NA
- Development phase
- 423
- Enrollment target
NCT04846504 is a NA study that has completed, run by Kaiser Permanente. The registered enrollment target is 423 participants.
The verdict
NCT04846504, a NA study, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- NA
- Development phase
- 423 participants
- Enrollment target
Study Summary
The Mindful Mood Balance for Moms (MMBFM) study examines whether using an internet program called Mindful Mood Balance for Moms to deliver Mindfulness Based Cognitive Therapy (MBCT) over an 8-week time period, is effective for reducing depression symptoms among pregnant women with a history of prior depression, and studies the effects of implementation strategies on the reach of the MMBFM program. This study will enroll 470 women from Kaiser Permanente Colorado, Southern California, Georgia. The investigators will compare clinical outcomes between those that receive mental health clinician coaching and those that receive peer coaching throughout the 8-week program. Survey data will be collected at 4 time points throughout the study (baseline, 12 weeks, 3rd trimester, and 3 months postpartum). The cost-effectiveness of both the clinical and peer coaching models at each health care system will be evaluated. For the implementation portion of the study, 30 OB clinics across the 4 health systems will be randomized in equal numbers to provide clinician facing implementation strategies (e.g., recruitment flyers, script pads, electronic medical record prompts) to encourage engagement in the MMBFM program or to usual care where women are only recruited by the study team with no clinician involvement. The primary outcome for testing clinician facing implementation strategies is reach, the percentage of women outreached who initially engage in the MMBFM program.
Interventions
- BEHAVIORAL MMBFM program with clinician coach support
- BEHAVIORAL MMBFM program with peer coach support
- BEHAVIORAL Patient facing strategy intervention arm
- BEHAVIORAL Patient facing plus clinic facing strategy intervention arm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 423 participants |
| Start Date | 2021-09-27 |
| Est. Completion | 2023-08-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04846504
The ClinicalTrials.gov registry entry for NCT04846504 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 423 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaiser Permanente, which has 294 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which MMBFM program with clinician coach support is the first listed.
NCT04846504 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04846504 about?
NCT04846504 is a clinical study titled "Accelerating Implementation of Mindful Mood Balance for Moms". The Mindful Mood Balance for Moms (MMBFM) study examines whether using an internet program called Mindful Mood Balance for Moms to deliver Mindfulness Based Cognitive Therapy (MBCT) over an 8-week time period, is effective for reducing depression symptoms among pregnant women with a history of prior...
What is the current status of trial NCT04846504?
This trial is currently completed. It is a NA study. The enrollment target is 423 participants. The study started on 2021-09-27. Estimated completion is 2023-08-30.
What interventions are being tested in trial NCT04846504?
The interventions under investigation include: MMBFM program with clinician coach support (BEHAVIORAL), MMBFM program with peer coach support (BEHAVIORAL), Patient facing strategy intervention arm (BEHAVIORAL), Patient facing plus clinic facing strategy intervention arm (BEHAVIORAL).
Who is sponsoring clinical trial NCT04846504?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
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