MHRN III Signature Project 1: Mindfulness-Based Cognitive Therapy to Prevent Perinatal Depression

Grant Details

Funder: NIMH

Grant Number: U19MH121738

Grant Period: 9/23/2019 – 6/30/2024

Narrative: An increasing number of digital mental health technologies are being developed to expand access to mental health treatments and deliver them in a cost-effective manner. Although efficacy trials of these technologies demonstrate improved patient outcomes, especially when combined with coaching support, there is little evidence that such digital tools can be widely implemented and sustained in routine care settings.

Perinatal depression is one area of significant public health concern where the role of digital mental health technology is especially relevant. Approximately 30-40% of women with histories of depression experience relapse during the perinatal period, a majority show poor adherence to antidepressants (ADs), the most common prevention treatment, and a majority express a preference for non-pharmacologic treatments. However, effective and easily accessible non-pharmacologic treatments are not widely available. Inadequate treatment for perinatal depression poses unique risks, including potential obstetrical and neonatal complications associated with perinatal depression itself and with fetal exposure to ADs. It is therefore imperative to test the implementation of effective and scalable non-pharmacological treatments to reduce the risk of depression relapse in the perinatal period.

Mindfulness-Based Cognitive Therapy (MBCT) is a promising preventive intervention for pregnant women with recurrent depression (as well as for adults in general), demonstrating significant reductions in rates of depressive relapse and residual depressive symptoms. MBCT is an eight-session in-person group intervention targeting risk factors for depressive relapse through a combination of mindfulness meditation and cognitive-behavioral strategies. Because of challenges in delivering in-person MBCT (difficulty for health systems to scale up the intervention, barriers to access for pregnant women), we developed a mobile-first digital adaptation of MBCT for pregnant women, Mindful Mood Balance for Moms (MMBFM).

The critical next phase of our work is to evaluate the potential of MMBFM as an effective intervention that can be more widely adopted, implemented, and sustained across heterogeneous patient populations and health care systems. We propose a large pragmatic hybrid type II effectiveness–implementation trial comparing MMBFM to usual care (UC) among pregnant women at risk for recurrent depression at four MHRN sites: KP Colorado, KP Southern California, HealthPartners, and KP Georgia to address the following aims:

AIM 1: Test the effectiveness of MMBFM in reducing depression symptoms, reducing risk of relapse or significant worsening, and improving perinatal outcomes when implemented in real-world health systems.

AIM 2: Evaluate the incremental cost-effectiveness of MMBFM compared to UC.

AIM 3: Evaluate healthcare system’s implementation of MMBFM using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) model.

  • Lead Site:
    • Overall PI: KPCO (Project lead Arne Beck)
  • Participating Sites/Subcontractors:
    • HPI (Site PI Kristen Palmsten)
    • KPGA (Site PI Courtney McCracken)
    • GSU (Site PI and site project lead for KPGA Ashli Owen-Smith)
    • KPNW (Site PI Frances Lynch)
    • KPSC (Site PI Karen Coleman)
    • UCB (Co-I Sona Dimidjian)
  • Funder Contacts
    • Science Officer: Susan Azrin
    • Program Official: Michael Freed
    • Grants Management Official: Julie Bergerud

Documents

Funding Announcement

Notice of Award

Personnel Contact List

Current status

Enrollment is approximately 80% complete for the randomized trial comparing depression outcomes for participants in the Mindful Mood Balance for Moms (MMBFM) online program who receive professional or peer telephonic coaching. All four sites have engaged their OB leaders and stakeholders and are starting the cluster randomized trial to assess the impact of  implementation strategies on participants’ initial engagement in the MMBFM program. Coaching trial enrollment will be complete by end of 2022, and implementation trial enrollment will be complete by second quarter of 2023. Follow-up data collection through three months postpartum and data analysis for both trials and for the cost-effectiveness analysis will be conducted from third quarter 2023 through third quarter of 2024.

Summary of findings

Not yet available

Publications

None

MHRN III Infrastructure: Methods Core

Grant Details

Funder: NIMH

Grant Number: U19MH121738

Grant Period: 09/23/2019 – 06/30/2020

Narrative: The Methods Core will include an Informatics Unit, led by Drs. Gregory Simon and Christine Stewart, and a Scientific Analysis Unit, led by Drs. Susan Shortreed and Patrick Heagerty. The Informatics Unit will continue highly successful work over the past 8 years, supporting routine data quality assessment and descriptive analyses of diagnosis and treatment patterns across all participating health systems. New work will include development of tools and resources to assess and minimize privacy risks when sharing sensitive health data for research and development of specific new data areas (perinatal mental health and prenatal exposures, expanded list of patient-reported outcomes, and assessments of social determinants of health). The Informatics Unit will provide consultation to all MHRN core and affiliated projects and share all resources with other researchers and health systems via MHRN’s public repository of specifications, code lists, and analytic code. The Scientific Analysis Unit will support to all MHRN core and affiliated projects via project-specific consultation and development of a learning community of analysts and biostatisticians across MHRN research centers. This Unit will also focus on development and dissemination of analytic methods in two areas directly relevant to MHRN research. Work on evaluating adaptive treatment strategies will build on Dr. Shortreed’s recently funded methods grant to evaluate and disseminate methods for using health system data to tailor treatments for individuals with more chronic or severe mental health conditions, focusing on assessing treatment effects when treatments are adjusted or switched according to previous treatment failures or adverse effects. Work on stakeholder-driven predictive analytics will build on MHRN’s development of accurate suicide risk prediction models, focusing on matching specific study designs and model development methods with stakeholder priorities and implementation constraints.

Lead Site: KPWA (PI Greg Simon)

Participating Sites: University of Washington (Site PI Patrick Heagerty) 

  • Funder Contacts
    • Science Officer: Susan Azrin
    • Program Official: Michael Freed
    • Grants Management Official: Jackie Chia

Documents & Reports

Submitted Proposal

Specific Aims

Research Plan

Notice of Award

Personnel Contact List

Publications

MHRN III Supplemental Project: Effect of COVID-19 Pandemic on Mental Health Service Use

Grant Details

Title: Impact and Implications of Rapid Transition to Virtual Mental Health Care during COVID-19

Funder: NIMH

Grant Number: 3U19MH121738-02S1

Grant Period: 9/30/2020 – 6/30/2021

Narrative: The Mental Health Research Network conducts practice-based mental health research in large healthcare systems serving over 25 million patients in 16 states, with a focus on having large-scale data infrastructure available for rapid analyses. This study takes advantage of that infrastructure to study how changing from in-person to phone- or video visits during the COVID-19 crisis disrupts care of people with mental health conditions, including those in important and potentially disadvantaged subgroups. This work will help us understand who needs more support during crises as well as determine who benefits most from telehealth visits as the field of behavioral health care continues to transition to using more of these services.

  • Lead Site:
    • Overall PI: HPI (Project lead/site PI Rebecca Rossom)
  • Participating Sites/Subcontractors:
    • HFHS (project co-lead/site PI Brian Ahmedani)
    • KPWA (PI Greg Simon, co-I Rob Penfold)
  • Funder Contacts
    • Science Officer: Susan Azrin
    • Program Official: Michael Freed
    • Grants Management Official: Julie Bergerud
  • Awarded Budget (Total Cost)
    •  $344,930

Documents

Funding Announcement

Personnel Contact List

Current status

Data extraction is completed at all participating sites.  The first set of analyses examining changes in suicide death outcomes before and after onset of the COVID-19 pandemic were completed and the manuscript was published in Medical Care.  Preliminary analyses of counts and rates examining visit patterns, diagnoses, and treatment patterns before and after onset of the pandemic have been completed.  Additional primary analyses are ongoing for each of these metrics.  Final data analyses will be completed in late 2022.

Summary of findings

In participating health systems, overall suicide mortality declined slightly during the first months of the COVID-19 pandemic.

Among people receiving specialty mental health care, likelihood of interrupting treatment was slightly lower after the shift to telehealth delivery than before the pandemic.

Publications

Rossom RC, Penfold RB, Owen-Smith AA, Simon GE, Ahmedani BK. Suicide Deaths Before and During the Coronavirus Disease 2019 Pandemic: An Interrupted Time-series Study. Med Care. 2022 Mar 1. doi: 10.1097/MLR.0000000000001700. Online ahead of print. PMID: 35230276.

MHRN III Infrastructure: Administrative Core

Grant Details

Funder: NIMH

Grant Number: U19MH121738

Grant Period: 09/23/2019 – 06/30/2020

  • Narrative:​ Practice-based research has the potential to dramatically improve the speed, efficiency, relevance, and impact of mental health clinical and services research.  Mental Health Research Network (MHRN) III will include 14 research centers embedded in health systems serving a combined population of over 25 million patients in 16 states.  MHRN infrastructure will be enhanced to support a next-generation practice-based network, including:
    • Increased engagement of patients, health system leaders, and other stakeholders in network governance
    • An expanded public, open-source library of software tools and other technical resources
    • More formal processes for conducting feasibility pilot projects and rapid response to stakeholder queries
    • Expanded outreach to external stakeholders and research partners
  • Lead Site: KPWHRI
    • Overall PI: Greg Simon
  • Participating Sites/Subcontractors:
    • Baylor Scott & White – Site PI: Katherine Sanchez
    • Cornell University – Site PI: Jyotishman Pathak
    • Essentia Institute of Rural Health – Site PI: Stephen Waring
    • Georgia State University – Site PI: Ashli Owen-Smith
    • Harvard Pilgrim – Site PI: Christine Lu
    • HealthPartners – Site PI: Rebecca Rossom
    • Henry Ford Health System – Site PI Brian Ahmedani
    • KP Colorado – Site PI: Arne Beck
    • KP Georgia – Site PI Courtney McCracken
    • KP Hawaii – Site PI: Yihe Daida
    • KP Northern California – Site PI: Stacy Sterling
    • KP Northwest – Site PI: Frances Lynch
    • KP Southern California – Site PI: Karen Coleman
    • PalAlto Medical Foundation – Site PI: Ellis Dillon
  • Funder Contacts
    • Science Officer: Susan Azrin
    • Program Official: Michael Freed
    • Grants Management Official: Jackie Chia
  • Awarded Budget (Total Cost)
    • Year 1: $2,220,745
    • Year 2: $2,052,966
    • Year 3: $2,035,335
    • Year 4: $2,000,066
    • Year 5: $1,967,876

Documents & Reports

  • IRB Review
    • KPWA IRBnet file: [ 1475733 ]
    • KPWA IRB is single IRB reviewing for BSWH, HPHC, HPI, KPNC, KPNW, and KPSC.
    • EIRH, HFHS, KPCO, (KPGA?), KPHI, and PAMF IRB determination that work is exempt.
    • GSU and UW IRB determination that work is research not involving human subjects.

Personnel Contact List

Funded feasibility pilot projects

Publications

MRHN III Supplemental Project: Effect of Initiating Buprenorphine on Suicidal Behavior

Grant Details

Title: Buprenorphine Effect on Suicidal Behavior

Funder: NIMH

Grant Number: U19MH121738-02S2  (supplement to main MHRN cooperative agreement)

Grant Period: 9/17/2020 – 8/31/2022

Narrative: This large observational study will evaluate the effects of initiating buprenorphine treatment on subsequent suicidal behavior among people with opioid use disorder, including those with and without co-occurring mental health conditions or other known risk factors for suicidal behavior. We will use comprehensive health records data from four large health systems serving a combined member/patient population of approximately 11 million. Analyses will examine the overall effect of buprenorphine treatment on subsequent suicide attempts or death, heterogeneity of effects in patient subgroups, and specificity of effects to buprenorphine vs other medications.

We will be using previously developed suicide risk prediction tools to compare the outcomes of individuals who do and do not use buprenorphine with similar baseline suicide risk.

  • Lead Site: KPWA
    • Overall PI: Greg Simon
  • Participating Sites/Subcontractors:
    • KPNC – Site PI: Cynthia Campbell
    • KPSC – Site PI: Rulin Hechter
    • Henry Ford – Site PI: Brian Ahmedani
  • Funder Contacts:
    • Science Officer: Susan Azrin
    • Program Official: Michael Freed
    • Grants Management Official: Julie Bergerud
  • Awarded Budget (Total Cost):
    • Year 1: $514,616
    • Year 2: $274,321

Documents

Funding Announcement: PA-18-591

Notice of Award

Personnel Contact List

Human Subjects: YES

  • IRB Review:
    • KPWA is single IRB reviewing for KPWA, KPNC, and KPSC – Approved waiver of consent for use of records data
    • Henry Ford determined to be exempt
    • KPWA IRBnet File: [1649129]

Clinical Trial: NO

Current status

Exploratory analyses (in preparation for extraction of data at each site) have examined availability and quality of data regarding opioid medication use, availability and quality of data regarding injury and poisoning events, and types of visits occurring prior to initial buprenorphine prescriptions.  These analyses are informing refinements to research design and data specifications.  Final data extraction will occur during in October 2022 with analyses complete in early 2023.

Summary of findings

Not yet available

Publications

None