Accelerating Implementation of Mindful Mood Balance for Moms

Completed · Not applicable

Conditions studied: Perinatal Depression

In brief

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.

Key facts

Study ID

NCT04846504

Run by

Kaiser Permanente

People needed

423

Starts

2021-09-27

Expected to finish

2023-08-30

Last updated by the study team

2023-10-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Aged 18 years or older, receiving prenatal care at one of the 4 participating health systems
• 12-24 weeks gestation
• >= 1 prior episode of major depressive disorder, self-reported
• Current Patient Health Questionnaire 9-item (PHQ9) depression score <=9.
• Have internet access through home computer, smart phone, or similar device

You may not qualify if…

• Non-English speaking
• Past history of a psychotic, bipolar disorder, or substance misuse disorder within the past 6 months
• Immediate risk of self-harm
• PHQ9 score <5 or >9
• Patients who are on the "do not call" list for research

Where it is running

• Kaiser Permanente Southern California — San Diego, California, United States
• Kaiser Permanente Colorado — Denver, Colorado, United States
• Kaiser Permanente Georgia — Atlanta, Georgia, United States
• HealthPartners — Bloomington, Minnesota, United States

Full record on ClinicalTrials.gov

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