Accelerating Implementation of Mindful Mood Balance for Moms (MMB4Moms)

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 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.

Study Overview

• Status: Completed
• Conditions: Perinatal Depression
• Intervention / Treatment: 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

Detailed Description

Specific Aims

Informed by the Consolidated Framework for Implementation Research, a leading implementation science framework, this hybrid type III effectiveness implementation study will evaluate specific implementation strategies for MMBFM. Consistent with a hybrid type III study, there are two goals: (1) compare the clinical effectiveness of MMBFM supported by mental health clinician vs. peer coaches in a randomized trial of 470 pregnant women; and (2) compare the reach of MMBFM across OB clinics for two sets of implementation strategies to facilitate access to and initial engagement in MMBFM: patient facing strategies (PFS - direct outreach to women following prenatal visits via secure patient portal, email, text, or mail) vs. patient facing strategies combined with clinician facing strategies (PFS+CFS - Electronic Medical Record (EMR)-embedded prompts for OB providers, printed prescription pads for providers, flyers). A cluster randomized design will be used, randomizing 30 OB clinics across 4 health systems to either of these two implementation conditions, to assess their impact on reach. The investigators will address the following specific aims:

Aim 1: Compare the clinical effectiveness (i.e. engagement and symptom reduction) of MMBFM supported by clinician vs. peer coaches among women with a history of prior depressive episodes. Hypothesis 1: Coaching delivered by mental health clinicians vs. peers with lived experience will be associated with equivalent reductions in depressive symptoms at 6 months post-randomization.

Aim 2: Examine specific mechanisms of action for MMBFM participants receiving clinician vs. peer coaching. Hypothesis 2a: MMBFM participants receiving peer coaching will report less self-stigma and social isolation than those receiving clinician coaching, and MMBFM participants receiving clinician coaching will report less ruminative response to negative affect and greater decentering at 6 months post-randomization than those receiving peer coaching. Hypothesis 2b: Any difference between peer and clinician coaching in depression outcomes will be mediated by treatment-specific targets - at least partially via increased engagement.

Aim 3: Examine the effects of specific implementation strategies on reach of the MMBFM program. Hypothesis 3: Clinician facing implementation strategies (CFS) in combination with patient facing strategies (PFS) will lead to higher rates of reach than patient facing strategies alone.

Aim 4: Estimate the cost-effectiveness of MMBFM supported by clinician vs. peer coaches. Hypothesis 4: MMBFM will be more cost-effective when supported by peer vs. clinician coaches.

The trials of implementation strategies at the individual and clinic levels will be conducted at four health systems representing diversity in geographic location and in racial and ethnic membership: Kaiser Permanente Colorado, Southern California, and Georgia, and HealthPartners in Minnesota. These sites include 95 clinics and more than 400 obstetric clinicians (OB physicians, nurse practitioners, midwives, nurses), providing prenatal care for 53,000 women annually. The implementation trial for Aims 1 and 2 will recruit 470 women following prenatal care visits total across the four health systems and randomize them in equal numbers to participate in one of the two coaching arms for the MMBFM program, lasting 8 weeks. The clinic-level implementation trial (Aim 3) will involve a cluster randomized design in which 30 OB clinics will be recruited from the four health systems and randomized in equal numbers to either the PFS or PFS+CFS intervention arms, lasting 6 months. The individual- and clinic-level trials will be conducted in parallel.

The 8-session MMBFM program teaches mindfulness practice and cognitive behavioral skills to help reduce automatic, depressogenic modes of thoughts, emotions, and sensations. MMBFM is delivered in a mobile first digital format, accessible from desktop or mobile devices, and provided in an individually tailored manner that includes experiential practice, video-based vicarious learning, and didactic information.

• Study Type: Interventional
• Enrollment (Actual): 423
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arne Beck, PhD; Phone Number: 303-636-2474; Email: arne.beck@kp.org
• Study Contact Backup: Name: Erica Morse, MA; Phone Number: 303-636-2469; Email: erica.f.morse@kp.org

Study Locations

• United States
  • California
    • San Diego, California, United States, 92116
      • Kaiser Permanente Southern California
  • Colorado
    • Denver, Colorado, United States, 80014
      • Kaiser Permanente Colorado
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Kaiser Permanente Georgia
  • Minnesota
    • Bloomington, Minnesota, United States, 55425
      • HealthPartners

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MMBFM program with clinician coach support; 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; 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.
Active Comparator: MMBFM program with peer coach support; 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; 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.
Active Comparator: Patient facing strategy intervention arm; 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; 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.
Active Comparator: Patient facing plus clinic facing strategy intervention arm; 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; 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Generalized Anxiety Disorder 7-item (GAD-7) questionnaire scores from baseline through 3 months postpartum	Anxiety symptom severity, scores range from 0 (low) to 21 (high)	Baseline, 3 months post-randomization, 3rd trimester, 3 months postpartum
Change in Perceived Stress Scale scores from baseline through 3 months postpartum	Stress symptoms measured by a 10-item likert-type scores range from 0 to 40 with higher scores indicating higher perceived stress.	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	Change in attitudes toward motherhood. The 12-item AToM will measure participants' attitudes toward their infants using likert-type responses. Scores range from 0 (positive attitudes) to 60 (negative attitudes).	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	The SF-12 is a 12-item measure of physical and mental functional status. Scores range from 0 (low functional status) to 100 (high functional status)	Baseline, 3 months post-randomization, 3rd trimester, 3 months post partum
The TWente Engagement with Ehealth Technologies Scale (TWEETS)	TWEETS will measure user engagement with the Mindful Mood Balance for Moms program. TWEETS is a 9-item Likert-type scale with scores ranging from 9 (high engagement) to 45 (low engagement)	3 months post-randomization
Client Satisfaction Questionnaire (CSQ)	The CSQ will measure satisfaction with the Mindful Mood Balance for Moms program. It is an 8-item questionnaire using different Likert-type responses for each item. Scores range from 8 to 32, with higher values indicating higher satisfaction.	3 months post-randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Ruminative Responses Scale (RRS) short form scores from baseline through 3 months post-randomization	The 10-item RRS will measure rumination in response to negative affect using likert-type items. Scores range from 10 (low rumination) to 40 (high rumination)	Baseline, 3 months post-randomization
Change in Experiences Questionnaire (EQ) scores from baseline through 3 months post-randomization	The EQ is a 20-item likert-type scale measuring participant's abilities to decenter, i.e., the ability of viewing the self as separate and different from its own thoughts, the capacity of non-reacting to negative experiences, as well as the ability to be self-compassionate. scores range from 20 (low decentering) to 80 (high decentering).	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	The ULS-6 is a 6-item scale measuring social isolation using likert-type items. Scores range from 0 (low social isolation) to 18 (high social isolation).	Baseline, 3 months post-randomization
Change in Self-stigma of depression scale (SSDS) scores scores from baseline through 3 months post-randomization	The SSDS is a 16-item likert-type scale measuring one's perceived self-stigma with depression. Scores range from 16 (high self-stigma) to 80 (low self-stigma).	Baseline, 3 months post-randomization
Attitudes toward coaches	Participants' ratings of their level of comfort with clinician and peer coaches using a Likert-type scale for each type of coach, ranging from 1 (not at all comfortable) to 4 (very comfortable)	Baseline

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: National Institute of Mental Health (NIMH); Emory University; University of Toronto; HealthPartners Institute; University of Colorado, Boulder; Georgia State University
• Investigators: Principal Investigator: Arne Beck, PhD, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Mindfulness; Perinatal Depression; Mindfulness Based Cognitive Therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: U19MH121738 (U.S. NIH Grant/Contract); 5U19MH121738-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No