Clinical trial NCT04846504: Accelerating Implementation of Mindful Mood Balance for Moms
Official title: Accelerating Implementation of Mindful Mood Balance For Moms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Depression
Keywords: Mindfulness Based Cognitive Therapy
Mindfulness
Perinatal Depression
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: HealthPartners Institute
name: Georgia State University
name: University of Colorado, Boulder
name: University of Toronto
name: Emory University
name: National Institute of Mental Health (NIMH)
First posted: 2021-04-15
Enrollment: 423
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Patient Health Questionnaire 9-item (PHQ-9) scores from baseline through 3 months postpartum
timeFrame: Baseline, 3 months post-randomization, 3rd trimester, 3 months postpartum
measure: Reach
timeFrame: 6 months post-intervention involving patient facing vs. clinician facing implementation strategies
Secondary outcomes:
measure: Change in Generalized Anxiety Disorder 7-item (GAD-7) questionnaire scores from baseline through 3 months postpartum
timeFrame: Baseline, 3 months post-randomization, 3rd trimester, 3 months postpartum
measure: Change in Perceived Stress Scale scores from baseline through 3 months postpartum
timeFrame: Baseline, 3 months post-randomization, 3rd trimester, 3 months post partum
measure: Change in Attitudes Toward Motherhood (AToM) Scale scores from baseline through 3 months postpartum
timeFrame: Baseline, 3 months post-randomization, 3rd trimester, 3 months post partum
measure: Change in Short Form 12 (SF-12) scores from baseline through 3 months postpartum
timeFrame: Baseline, 3 months post-randomization, 3rd trimester, 3 months post partum
measure: The TWente Engagement with Ehealth Technologies Scale (TWEETS)
timeFrame: 3 months post-randomization
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 3 months post-randomization
Other outcomes:
measure: Change in Ruminative Responses Scale (RRS) short form scores from baseline through 3 months post-randomization
timeFrame: Baseline, 3 months post-randomization
measure: Change in Experiences Questionnaire (EQ) scores from baseline through 3 months post-randomization
timeFrame: Baseline, 3 months post-randomization
measure: Change in University of California, Los Angeles (UCLA) Loneliness Scale (ULS-6) scores scores from baseline through 3 months post-randomization
timeFrame: Baseline, 3 months post-randomization
measure: Change in Self-stigma of depression scale (SSDS) scores scores from baseline through 3 months post-randomization
timeFrame: Baseline, 3 months post-randomization
measure: Attitudes toward coaches
timeFrame: Baseline
Locations:
city: San Diego
country: United States
facility: Kaiser Permanente Southern California
state: California
city: Denver
country: United States
facility: Kaiser Permanente Colorado
state: Colorado
city: Atlanta
country: United States
facility: Kaiser Permanente Georgia
state: Georgia
city: Bloomington
country: United States
facility: HealthPartners
state: Minnesota
Study officials:
affiliation: Kaiser Permanente
name: Arne Beck, PhD
role: PRINCIPAL_INVESTIGATOR
References: