Accelerating Implementation of Mindful Mood Balance for Moms

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.

Conditions

• Perinatal Depression

Interventions

BEHAVIORAL

MMBFM program with clinician coach support

Clinician-delivered telephonic coaching to support participants in the Mindful Mood Balance for Moms online course for prevention of depression relapse/recurrence among perinatal women who have had prior episodes of depression but are not currently depressed.

BEHAVIORAL

MMBFM program with peer coach support

Peer-delivered telephonic coaching to support participants in the Mindful Mood Balance for Moms online course for prevention of depression relapse/recurrence among perinatal women who have had prior episodes of depression but are not currently depressed. Peers will be women with lived experience of perinatal depression who are trained on the coaching protocol.

BEHAVIORAL

Patient facing strategy intervention arm

Direct outreach and recruitment of participants into Mindful Mood Balance for Moms study by study teams. Participants will be women receiving prenatal care at the 4 study sites: Kaiser Permanente Colorado, Southern California, and Georgia, and HealthPartners.

BEHAVIORAL

Patient facing plus clinic facing strategy intervention arm

Direct outreach and recruitment of participants into Mindful Mood Balance for Moms study by study teams, plus recommendation of / referral to the Mindful Mood Balance for Moms study by OB clinicians at the 4 study sites. OB clinicians will choose from printed materials (e.g., flyers, posters in exam rooms and waiting rooms, prescription pads) and electronic medical record prompts (e.g., smart lists, dot phrases) to facilitate engagement in the Mindful Mood Balance for Moms course. Participants will be women receiving prenatal care at the 4 study sites: Kaiser Permanente Colorado, Southern California, and Georgia, and HealthPartners.

Sponsors & Collaborators

• HealthPartners Institute

  collaborator OTHER

• Georgia State University

  collaborator OTHER

• University of Colorado, Boulder

  collaborator OTHER

• University of Toronto

  collaborator OTHER

• Emory University

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Kaiser Permanente

  lead OTHER

Principal Investigators

• Arne Beck, PhD · Kaiser Permanente

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-09-27

Primary Completion

2023-06-30

Completion

2023-08-30

Countries

• United States

Study Locations