Accelerating Implementation of Mindful Mood Balance for Moms

NCT04846504 | Completed DMC

• 2 other identifiers: U19MH1217385U19MH121738-02
• Study Type: interventional
• Target: 423
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Mindfulness Based Cognitive Therapy; Mindfulness; Perinatal Depression

Outcome Measures

Primary Outcomes (2)

• Change in Patient Health Questionnaire 9-item (PHQ-9) scores from baseline through 3 months postpartum

  Depression symptom severity, scores range from 0 (low) to 27 (high)

  Baseline, 3 months post-randomization, 3rd trimester, 3 months postpartum

• Reach

  The percentage of participants who initially engage in the Mindful Mood Balance for Moms course.

  6 months post-intervention involving patient facing vs. clinician facing implementation strategies

Secondary Outcomes (6)

• Change in Generalized Anxiety Disorder 7-item (GAD-7) questionnaire scores from baseline through 3 months postpartum

  Baseline, 3 months post-randomization, 3rd trimester, 3 months postpartum

• Change in Perceived Stress Scale scores from baseline through 3 months postpartum

  Baseline, 3 months post-randomization, 3rd trimester, 3 months post partum

• Change in Attitudes Toward Motherhood (AToM) Scale scores from baseline through 3 months postpartum

  Baseline, 3 months post-randomization, 3rd trimester, 3 months post partum

• Change in Short Form 12 (SF-12) scores from baseline through 3 months postpartum

  Baseline, 3 months post-randomization, 3rd trimester, 3 months post partum

• The TWente Engagement with Ehealth Technologies Scale (TWEETS)

  3 months post-randomization

Other Outcomes (5)

• Change in Ruminative Responses Scale (RRS) short form scores from baseline through 3 months post-randomization

  Baseline, 3 months post-randomization

• Change in Experiences Questionnaire (EQ) scores from baseline through 3 months post-randomization

  Baseline, 3 months post-randomization

• Change in University of California, Los Angeles (UCLA) Loneliness Scale (ULS-6) scores scores from baseline through 3 months post-randomization

  Baseline, 3 months post-randomization

Study Arms (4)

MMBFM program with clinician coach support

ACTIVE COMPARATOR

Telephonic coaching provided by licensed mental health professionals to support and encourage participants' engagement in and completion of the 8-session online MMBFM program.

Behavioral: MMBFM program with clinician coach support

MMBFM program with peer coach support

ACTIVE COMPARATOR

Telephonic coaching provided by trained peers with lived experience of perinatal depression to support and encourage participants' engagement in and completion of the 8-session online MMBFM program.

Behavioral: MMBFM program with peer coach support

Patient facing strategy intervention arm

ACTIVE COMPARATOR

Centralized outreach and recruitment of women receiving prenatal care by study team using email, letter, or text, without direct involvement of OB providers.

Behavioral: MMBFM program with clinician coach support; Behavioral: MMBFM program with peer coach support; Behavioral: Patient facing strategy intervention arm

Patient facing plus clinic facing strategy intervention arm

ACTIVE COMPARATOR

OB clinic providers' use of printed recruitment materials and/or electronic medical records prompts to recommend/refer women receiving prenatal care to access the MMBFM program. These clinic facing implementation strategies will be added to the patient facing strategies of centralized outreach and recruitment of women receiving prenatal care by study team using email, letter, or text

Behavioral: MMBFM program with clinician coach support; Behavioral: MMBFM program with peer coach support; Behavioral: Patient facing plus clinic facing strategy intervention arm

Interventions

MMBFM program with clinician coach support BEHAVIORAL

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.

MMBFM program with clinician coach support; Patient facing plus clinic facing strategy intervention arm; Patient facing strategy intervention arm

MMBFM program with peer coach support BEHAVIORAL

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.

MMBFM program with peer coach support; Patient facing plus clinic facing strategy intervention arm; Patient facing strategy intervention arm

Patient facing strategy intervention arm BEHAVIORAL

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.

Patient facing strategy intervention arm

Patient facing plus clinic facing strategy intervention arm BEHAVIORAL

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.

Patient facing plus clinic facing strategy intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older, receiving prenatal care at one of the 4 participating health systems
• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• HealthPartners Institute: collaborator
• Georgia State University: collaborator
• University of Colorado, Boulder: collaborator
• University of Toronto: collaborator
• Emory University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (4)

Kaiser Permanente Southern California

San Diego, California, 92116, United States

Location

Kaiser Permanente Colorado

Denver, Colorado, 80014, United States

Location

Kaiser Permanente Georgia

Atlanta, Georgia, 30309, United States

Location

HealthPartners

Bloomington, Minnesota, 55425, United States

Location

Study Officials

• Arne Beck, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hybrid type III effectiveness implementation model testing implementation strategies at the individual and OB clinical level. Individual level strategies involve randomizing participants to receive telephonic coaching by professional or peer coach. Clinic level strategies involve randomizing OB clinics to use printed materials and/or electronic medical record prompts to recommend/refer participants to the Mindful Mood Balance for Moms (MMB4M) program or to usual care with no recommendations/referrals to the MMBFM program.

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 15, 2021
• Study Start: September 27, 2021
• Primary Completion: June 30, 2023
• Study Completion: August 30, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)