Tag: Pragmatic trials

A comparative effectiveness trial of strategies to implement firearm safety promotion as a universal suicide prevention strategy in pediatric primary care (ASPIRE)

Grant Details

Funder: NIMH

Grant number: R01MH123491

Project period: 08/15/2020 – 06/30/2025

Lead site: Northwestern University (PI Rinad Beidas)

Participating sites:

  • Kaiser Permanente Colorado (Site PI Jennifer Boggs)
  • Henry Ford Health System (Site PI Brian Ahmedani)
  • University of Pennsylvania (Site PI Kristin Linn)

Abstract: The proposed study will work to reduce firearm-related suicide deaths in young people by investigating the most effective way to implement a universal secure firearm storage program in pediatric primary care. The number of young people dying by suicide in the United States continues to rise, and risk for suicide death is much greater when there is an unlocked, loaded firearm in the home. A simulation study found that a modest increase in secure firearm storage could prevent up to 32% of firearm-related deaths in youth. Pediatric primary care is an ideal setting for universal suicide prevention strategies to reduce unauthorized access to firearms, and prior research has shown that both health care clinicians and parents find firearm safety to be an appropriate topic to discuss, yet these conversations do not happen routinely. Safety Check, an evidence-based practice for firearm safety promotion that involves brief counseling and provision of a free cable lock, has been shown to double the odds of self-reported secure storage among parents, but has not been implemented widely. Using feedback from pediatric clinicians, health system leaders, and firearm-owning parents regarding attitudes and barriers related to broader use of the program, the proposed study incorporates recommendations on how to boost the acceptability and feasibility of Safety Check for use as a universal suicide prevention strategy. Combining this feedback with insights from behavioral economics, we will conduct a hybrid type III effectiveness-implementation trial with a longitudinal cluster randomized design. The study will allow us to compare two approaches to implementing the program in pediatric primary care and evaluate the effectiveness of the adapted intervention, now named S.A.F.E. Firearm. The study will include 158 clinicians in 30 clinics who serve 48,475 youth annually in two MHRN health systems in Michigan and Colorado. All 30 clinics in the two participating health systems will receive S.A.F.E. Firearm materials, including brief training and cable locks. Half of the clinics (k = 15) will be randomized to receive the electronic health record (EHR) implementation strategy (Nudge); the other half will be randomized to receive Nudge plus 1 year of facilitation to target additional clinician and organizational implementation barriers (Nudge+). We will collect the primary implementation outcome, reach (proportion of eligible families that received the intervention), during the active implementation year and for 1 year following to allow for comparisons between the active and sustainment periods. Results will guide future efforts to promote firearm safety as a universal suicide prevention strategy. In Aim 1, we will identify the effect of the implementation strategies on implementation outcomes (i.e., reach, parent-reported receipt of the program [fidelity], cable lock distribution, acceptability, and cost). In Aim 2, we will also test potential implementation strategy mechanisms (i.e., how it worked). In Aim 3, we will examine clinical outcomes including parent-reported secure storage behavior. This study can improve implementation of firearm safety interventions and identify the best approach to national implementation, with the ultimate goal of saving the lives of American youth, in alignment with NIMH Objective 4.

Current status:

Enrolling by invitation.

Summary of findings:

The active implementation year will end in March 2023, and data analysis will be conducted during summer 2023. Manuscripts detailing study findings will submitted for peer review thereafter.

Publications:

Beidas, R. S., Ahmedani, B. K., Linn, K. A., Marcus, S. C., Johnson, C., Maye, M., … & Boggs, J. M. (2021). Study protocol for a type III hybrid effectiveness-implementation trial of strategies to implement firearm safety promotion as a universal suicide prevention strategy in pediatric primary care. Implementation Science, 16.

Davis, M., Johnson, C., Pettit, A. R., Barkin, S., Hoffman, B. D., Jager-Hyman, S., … & Beidas, R. S. (2021). Adapting Safety Check as a universal suicide prevention strategy in pediatric primary care. Academic Pediatrics, 21(7), 1161-1170.

Hoskins, K., Johnson, C., Davis, M., Pettit, A. R., Barkin, S., Jager-Hyman, S., … & Beidas, R. S. (2021). A mixed methods evaluation of parents’ perspectives on the acceptability of the S.A.F.E. Firearm program. Journal of Applied Research on Children: Informing Policy for Children at Risk, 12(2).

Hoskins, K., Linn, K. A., Ahmedani, B. K., Boggs, J. M., Johnson, C., Heintz, J., … & Beidas, R. S. (2022). Equitable implementation of S.A.F.E. Firearm: A multi-method pilot study. Preventive Medicine, 165.

Optimizing Care to Prevent Diabetes and Promote Cardiovascular Health Among Younger Adults with Severe Mental Illness

Grant Details

Funder: NIMH

Grant number: 1K23MH126078

Grant period: 4/1/2022 – 3/31/2027

Brief narrative: People with severe mental illness (SMI) face double the risk for type 2 diabetes compared to the general population, contributing to higher rates of cardiovascular disease and premature death. Common use of antipsychotic medications contributes to these health risks due to prevalent metabolic side effects. Many younger adults with SMI do not receive targeted, evidence-based cardiometabolic disease prevention care. Underused strategies include: prescribing alternative, less obesogenic psychotropic medications; lifestyle change supports; additional risk-reducing medications; and smoking cessation therapies. Our preliminary qualitative data with patients and clinicians identified a need for tools to match prevention care to individuals’ risk level and preferences, and tools suited to population-based care strategies. Clinical Decision Support (CDS) tools are computer algorithms that use patients’ data, predictive analytics, and clinical guidelines to promote evidence-based care by helping patients and clinicians navigate complex treatment decisions. Through this mentored K23 career development award, Esti Iturralde, PhD will build upon her background as a clinical psychologist and behavioral diabetes researcher. Through planned mentoring, coursework, and career development activities, Dr. Iturralde will gain a strong understanding of psychopharmacology and cardiometabolic health, advanced predictive analytics, and implementation science, including methods for stakeholder-engaged intervention design and pragmatic clinical trials. As a researcher in the Kaiser Permanente Northern California (KPNC) Division of Research (DOR), she will leverage robust, longitudinal electronic health record (EHR) data (> 50,000 adults from diverse racial/ethnic groups) and stakeholder insights (patients, clinicians, and health system decision-makers) within health systems including KPNC and 2 others belonging to the NIMH-funded Mental Health Research Network (HealthPartners Institute and Henry Ford Health System). The proposed research will support the training goals while contributing to the development of a novel CDS tool seeking to increase targeted, evidence-based diabetes and cardiovascular disease prevention care for adults under age 45 who are starting antipsychotic medications. Specific research aims are to: (1) inform predictive analytics of the CDS tool by developing and validating diabetes risk prediction models for the target population; (2) engage stakeholders in the design of CDS tool messaging and implementation pathways; and field-test CDS tool messaging through a pragmatic clinical trial conducted within an existing KPNC telehealth-based population management program serving this population. A future R01 application will build on the results from this project to further refine and test the CDS tool within multiple health systems. The linked research and training aims will directly prepare Dr. Iturralde for success as an embedded health system researcher and prepare her to lead a programmatic line of studies developing and implementing data-driven, feasible, scalable interventions improving the cardiometabolic health of people with SMI.

Lead site: KPNC (PI Esti Iturralde)

Current Status

Summary of Findings

Publications

Effectiveness of Task Shifting to Peer Delivery of Behavioral Activation for Depression among Pregnant Women

Grant Details

Funder: NIMH

Grant Number: R34MH110478

Grant Period: 9/14/2016 – 7/31/2019

Narrative: Depression is a prevalent problem during pregnancy, with adverse and potentially enduring correlates and consequences for mothers and infants; however, there is a persistent failure to provide intervention for the majority of depressed pregnant women, despite the fact that efficacious behavioral interventions exist. A widely recognized barrier to treatment engagement is the lack of effective, available care that is well aligned with women’s preferences. Pregnant women prefer care that is non-pharmacological and that is integrated within the obstetric setting, and they consult informal sources more than professional ones regarding mental health. Thus, to close the gap between treatment need and receipt among depressed pregnant women, it is imperative to examine delivery methods that are efficacious, non-pharmacological, and accessible in the obstetric setting and that expand options beyond traditional professional mental health care. This work is very timely given that recent clinical guidelines require obstetric providers not only to screen for depression but also to initiate medical treatment or refer women who screen positively for depression. As a result, many obstetric settings are likely to face increased detection without corresponding availability of mental health services. We address the pressing need for such interventions by developing and pilot testing the model of “task shifting” to peers, building on work in low- and middle-income countries within the global mental health context. Behavioral Activation (BA) is an excellent candidate for task shifting to peers to treat depression during pregnancy because it was developed to maximize scalability, has strong evidence of efficacy in the general population and among pregnant women, a clear and empirically supported conceptual framework, and evidence of efficacy as delivered by non-specialist and lay counselors. Peer delivery offers pragmatic advantages, is consistent with pregnant women’s preferences, and may engage social putative targets of depression care that are relevant to depression among women. Using a three-phase structure, the proposed research will develop BA peer delivery and web-based peer training and fidelity monitoring tools, and will evaluate the feasibility, tolerability, acceptability, safety, and preliminary effectiveness of BA peer delivery within obstetric practice settings. The proposed research also seeks to advance current research paradigms by integrating, within a pragmatic clinical trial context, a conceptually and empirically driven approach to the study of transdiagnostic outcomes and putative targets, consistent with an experimental therapeutics and RDoC approach. We combine the use of established self-report measures, which can be routinely used in clinical settings to maximize practice-relevance, and rigorous laboratory paradigms developed to probe key mechanistic processes specific to BA (negative and positive valence system processes) and potentially to peer delivery (social processes).

Lead Site: University of Colorado (PI Sona Dimidjian)

Participating Sites

Current Status

Summary of Findings

Publications

Assisted Identification and Navigation of Early Mental Health Symptoms in Youth

Grant Details

Funder: NIMH

Grant Number: R01MH124652

Grant Period: 1/18/2021 – 11/30/2024

Narrative: About 55% of children with significant mental health difficulties receive treatment and up to 80% of children with sub-clinical symptoms receive no treatment. Treatments are often not initiated until issues are significantly impacting the child and family. This study aims to conduct a pragmatic randomized trial in two non-academic health care systems to test a mental health family navigator model to promote early access to, engagement in, and coordination of needed mental health services for children. The first task of the study will focus on the implementation of a predictive model to identify symptomatic children with no diagnosed mental health disorder(s) or treatments initiated. The tool identifies patients with documentation of mental health symptoms or complaints in the free text of a progress note from a recent primary care or urgent care visit. Using this predictive algorithm, we will conduct a pragmatic randomized trial comparing intervention and usual care arm patients enrolled from Kaiser Permanente (KP) Washington and KP Northern California. The trial will enroll 200 patients per arm (n=400). Children with (1) a new mental health diagnosis but no treatment initiated; (2) a new mental health medication ordered with no mental health diagnosis; and (3) symptoms identified by the predictive model with no new mental health diagnosis or treatment initiated will be recruited. The study intervention will offer 6 months of support to the family by a mental health navigator (social worker). The navigator will perform an initial needs and barriers assessment with the family around mental health services, conduct ongoing motivational interviewing around mental health care, provide up to 4 psychotherapy sessions (when appropriate) via clinic-to-home video visits, help the family find and schedule with appropriate mental health providers in the community, and reach out ad hoc if mental health appointments or medication refills are missed. The primary outcome is the percentage of youth initiating psychotherapy. The secondary outcome is the percentage of youth with at least 4 mental health visits. We hypothesize that the intervention arm will have higher rates of psychotherapy use compared to the control arm. We will also assess initiation of psychotropic medications. All primary analyses will follow an intent-to-treat approach. A waiver of consent will be obtained to include data for all individuals offered the intervention in the analysis, regardless of the amount of intervention (“dose” of navigation) received.

Lead Site: KPWA (PI Rob Penfold)

Participating Site: KPNC

Current Status:

Recruitment is active at both KPWA and KPNC. N = 44 as of 10/25/2022.

Summary of Findings:

Publications:

STAR Caregivers – Virtual Training and Follow-up

Grant Details

Funder: NIMH

Grant Number: R01AG061926

Grant Period: 9/30/2018 – 5/31/2023

Narrative: Alzheimer’s Disease and related Dementias (ADRD) are debilitating conditions affecting more than 5 million Americans in 2014. It is projected that 8.4 million people with be diagnosed with ADRD over the next 15 years and health care costs attributable to ADRD are projected to be more than $1.2 trillion by 2050.  Behavioral interventions such as STAR-Caregivers are efficacious first-line treatments for managing BPSD endorsed by the Administration on Aging. However, the programs have not been implemented widely – partly due to the intensity/cost of the programs and difficulty conducting outreach. No study has investigated CG willingness to reduce or discontinue antipsychotic use. We propose a Stage III clinical trial to ascertain the feasibility and acceptability of STAR Virtual Training and Follow-up (STAR- VTF) in which (a) training materials are delivered electronically and learning is self-directed, (b) caregivers have two in-home visits with a social worker and (c) where caregivers receive support from a social worker via secure messaging (email) within a web-based portal. We will compare outcomes in the STAR-VTF group to an attention control group (mailed material plus generic secure messages). Our specific aims are: (1) Assess the feasibility and acceptability of STAR-VTF to caregivers; (2) Assess the feasibility and acceptability of the program from the payer perspective; and (3) Test the hypotheses that (H1) caregiver participants in STAR-VTF will have lower levels of caregiver burden at 8 weeks and 6 months compared to an attention control group; and (H2) PWD participants in STAR-VTF will have lower rates of daily antipsychotic medication use at 6 months compared to attention control. We propose to recruit 100 CG-PWD dyads (50 in each arm). This will be the first study to test a low intensity, self-directed caregiver training program with secure message support from social workers. It will also be the first study to measure changes in antipsychotic medication use by PWD after CG training. The study is also innovative because it brings together leading experts in caregiver training, health information management, and care management. Third, this will be the first study to use automated data and natural language processing to identify potential caregivers in need of education/support at a time when antipsychotic medication use begins. Results of this study will inform a future multi-site trial in the Mental Health Research Network.

Lead Site: KPWA (PI Rob Penfold)

Participating Sites: N/A

Current Status

Currently enrolling person-living-with-dementia – Caregiver dyads. Recruitment will end December 2022.

Summary of Findings

none yet

Publications

Ramirez M, Duran MC, Pabiniak CJ, Hansen KE, Kelley A, Ralston JD, McCurry SM, Teri L, Penfold RB. Family Caregiver Needs and Preferences for Virtual Training to Manage Behavioral and Psychological Symptoms of Dementia: Interview Study. JMIR Aging. 2021 Feb 10;4(1):e24965. doi: 10.2196/24965. PMID: 33565984; PMCID: PMC8081155.

Syncing Screening and Services for Suicide Prevention across Health and Justice Systems

Grant Details

Title: Project 1: Syncing Screening and Services for Suicide Prevention across Health and Justice Systems

Funder: NIMH

Parent project number: 1P50MH127512

Sub-project ID: 8576

Project period: 08/22/2022 – 07/31/2027

Brief Narrative: This is a 5-year Signature Project within the NIMH-funded P50 Suicide Prevention Center, titled The National Center for Health and Justice Integration for Suicide Prevention. As suicide rates in the United States continue to rise, with nearly 50,000 suicide deaths and over 1 million suicide attempts annually per most recent data, increased attention has been paid to how to best integrate and coordinate suicide risk identification and prevention across multiple sectors, where some of our most vulnerable community members “fall through the cracks” in the continuum of care. Perhaps nowhere is this need for coordination and integration more pronounced than at the intersection of the US jail system, with over 10 million admissions per year, and the community healthcare system; an intercept known to impact individuals at disproportionately high risk for suicide. Given that roughly 10% of all suicides in the US with known circumstances occur following a recent criminal legal stressor (often arrest and jail detention), reducing suicide risk in the year after jail detention could have a noticeable impact on national suicide rates. There is thus a vital need to develop suicide risk care pathways between jails and healthcare systems to offer immediate access to care. Yet this process has been stymied by major fissures in the integration of data and clinical information between jails and health systems, preventing effective coordination of care between these community sectors. To address these needs, the proposed Signature Project is a Hybrid Type I effectiveness-implementation trial that harmonizes local jail booking and release data with healthcare records at two large healthcare systems in Minnesota and Michigan, to identify health system patients who are released from jail, and to pair the data linkage with randomization into usual care or a multi-level health system suicide prevention care pathway (consisting of care coordination, Safety Planning, Caring Contacts, and a telehealth delivered Coping Long- Term with Active Suicide Program). In so doing, this project leverages the study team’s experience in health system data linkage in the NIMH-funded Mental Health Research Network, from which the participating healthcare systems were chosen, as well as in suicide prevention around the period of jail detention and release (i.e., in the SPIRIT Trial), and in telephone-based suicide prevention intervention (i.e., in ED-SAFE). The proposed project will randomize 1050 individuals into the 5S intervention at both sites (comparing to more than 60,000 people in a usual care no contact comparison arm). Findings on suicide attempt and death outcomes, healthcare utilization mechanisms, cost- effectiveness, and implementation factors will provide data for a future fully scaled implementation trial and widespread adoption in community settings. Notably, the proposed Signature Project will be the first trial of a comprehensive health system intervention to prevent suicide in response to patients’ justice involvement.

  • Lead MHRN site: HFHS (PI: Brian Ahmedani)
  • Participating site: HPI (co-I: Rebecca Rossom)

Population-based outreach to prevent suicide attempts: Too big a step?

Our randomized trial of outreach programs to prevent suicide attempts tested a long step beyond what we knew from previous research.  We hoped that low-intensity adaptations of proven effective interventions – delivered primarily online – could scale up to prevent suicide attempts at the population level.  And we were wrong.  Not only did neither of the programs we tested prevent self-harm or suicide attempts, one of them may have increased risk.

Looking back, we can say that we tried too long a step beyond interventions proven to work.  We can try to unpack that long step into a few smaller pieces.  First, our trial included the broad population of people at increased risk (where most suicide attempts occur) rather than the much smaller population of people at highest risk (where previous interventions had been tested).  Second, we emphasized outreach to people who were not seeking additional help rather than limiting to volunteers who agreed in advance to accept the extra services we were offering.  Third, we tested low-intensity interventions, delivered primarily by online messaging rather than more personal and intensive interventions delivered by telephone or face-to-face.

We could have started by separately testing each of those smaller steps rather than trying to cross the creek all at once.  But any smaller trial testing one of those small steps would have taken two or three years.  Testing one smaller step after another would have taken even longer.  Given rising suicide mortality rates throughout the 2010s, we chose not to wait several years before trying a large step.  We believed the programs we tested were close enough to the solid ground of proven interventions, and we certainly hoped they would expand the reach of effective prevention.

Regardless of the time required, it may not have been helpful to divide that big step into smaller pieces.  We could have limited the trial to people at highest risk, but then we would not have studied low-intensity online interventions.  We could have limited the trial to people who agreed in advance to accept extra services, but then we would not have studied outreach interventions.

After we published our findings, we did hear questions and suggestions about each piece of the big step we tried:  Why not focus on those at highest risk?  Why not test more intense or robust interventions?  Why include people who were not interested in the treatments you were offering?  But if we’d done all of those things, we would have just replicated research that was already done – and ended up right back where we started.  Back in 2015, we already knew that traditional clinical interventions, like Dialectical Behavior Therapy, could decrease risk in treatment-seeking people with recent self-harm or hospitalization.  Replicating that evidence would not inform population-based prevention programs for the broader population of people at increased risk.     

We are certainly not giving up on the idea of population-based programs to prevent suicidal behavior.  So we’re thinking about ways to try smaller steps.  Rather than small steps, we may need to look for a completely new place to get across the creek.  Our suggestion box is open.

Greg Simon

MHRN III Pilot Project 2: Outreach to Reduce Depression Treatment Disparities

Funder: NIMH

Grant Number: U19MH121738

Project Period: 07/01/2021 – 06/30/2024

Brief Narrative:

Failure to initiate treatment is a major gap in care for depression – A recent Mental Health Research Network (MHRN) study involving more than 240,000 patients in 5 health systems with a new diagnosis of depression in primary care found that only about a third (36%) had completed a psychotherapy visit or filled a prescription for antidepressant medication within 90 days of a new depression diagnosis.
Large racial and ethnic disparities in depression treatment initiation exist – In that MHRN study the odds of Asians, Blacks and Hispanics initiating treatment were 30% lower than for Non-Hispanic Whites.
Previous research has focused on care after treatment initiation – Collaborative care and care management programs can reduce disparities, improving outcomes among traditionally under-served racial and ethnic groups. This work, however, has usually focused on those who have already initiated treatment.
Interventions to improve treatment initiation must accommodate diversity of patient experience and preferences –Underserved racial and ethnic groups may prefer psychotherapy over medication and may also prefer alternative treatments or alternative care providers. One size of depression treatment does not fit all.
eHealth technologies have the potential to address failures in treatment initiation – Previous research by MHRN investigators and others demonstrates that online messaging and other telehealth technologies can effectively and efficiently improve depression treatment adherence. These interventions, however, have focused on adherence after treatment initiation and have been tested primarily in non-Hispanic white patients.
Proposed trial: This pilot study will refine, adapt and test an outreach intervention to improve depression treatment initiation among patients recently receiving a new diagnosis of depression in primary care. Focusing on African American, Asian, Native Hawaiian/Pacific Islander and Hispanic patients, the study will leverage existing MHRN work to implement an automated outreach program with follow-up care facilitation by mental health clinicians. The intervention will utilize analytic and technological expertise developed by the MHRN to rapidly identify patients, send outreach messages, conduct assessments and facilitate care for patients with depression who fail to initiate treatment in a timely manner. The intervention will be developed with the input of patients in the target racial and ethnic minority populations and providers. Approximately 400 eligible patients in two MHRN health systems will be randomized to the intervention group or usual care. Outcomes (treatment initiation and rates recorded depression remission and response) will be ascertained from health system records. Analyses will examine intervention participation and compare the primary outcome (treatment initiation) and secondary outcomes (recorded depression remission and response) between groups. Results will inform a subsequent full-scale pragmatic trial to assess reduction in population-level disparities.

  • Lead Site:
    • KPHI (PI Vanessa Simiola)
  • Participating Sites:
    • HFHS (Site PI Lisa Matero)
    • KPWA (Co-I Greg Simon)
  • Awarded Budget (total costs):
    • Year 1: $112,382

Current Status

Over the reporting period Institutional Board Approval has been granted and focus group materials have been finalized as part of the formative research. Eligible participants were identified within the health care systems via distributed SAS code. Participant recruitment is currently underway within one (KPHI) of the two health care systems, with online focus groups scheduled in the beginning of May. The second health care system (HFHS) is awaiting local IRB approval and will begin recruitment immediately following. Provider surveys are scheduled for the end of the reporting period.

Summary of findings

Not yet available

Publications

None

Documents

Funding Announcement

Notice of Award

Personnel Contact List

Human Subjects: YES

IRB Review: KPSC is single IRB reviewing for KPHI, HFHS, and KPWA. File #12874.

Clinical Trial: YES

Pragmatic Trial of Stepped Care for Adolescent Suicide Prevention (Youth SPOT)

Grant Details

Funder: Patient-Centered Outcomes Research Institute (PCORI)

Contract Number: PLACER-2020C3-20902

Project Period: 12/01/2021 – 11/30/2027

Brief narrative:

Adolescent suicide is the second leading cause of death in teenagers. Preventing suicide in teens would keep them safe, allow them to get the mental health help that they need, and also protect families, friends, and communities from grief and loss. There are several programs that have been shown to work for preventing suicide, including an approach called dialectical behavior therapy (DBT). However, the studies done so far are so small that it is still unknown whether DBT works for all groups of teens—teens at medium risk versus those at very high risk, boys versus girls, younger versus older teens—or whether different approaches may work better for some groups. This is important information, because it would help teens and their families to make the best choices from several suicide prevention program options. Hospitals, clinics, doctors, and therapists also need information about what suicide prevention services work best and should be made more available. The goal of this study is to answer these questions.

The first aim, which will be completed in the first 18 months of the project, will be to plan the main study comparing two approaches to suicide prevention in collaboration with young people who have lived with suicidal behavior, their parents, doctors, and therapists. The second aim will be to compare how well these two approaches work to prevent suicide attempts in a group of 9,800 teens. The third aim is to see whether the two approaches lead to differences in the mental health care each teen receives—like being hospitalized, taking medications, seeing therapists, and so on—and to see which program works best for different groups, such as young men versus young women, or Hispanic teens and those who are not Hispanic, as well as what works best for teens who are at medium, medium-high, and high risk for suicide.

The first suicide prevention approach is called “stepped care,” and offers three levels of services to teens, depending on their level of risk. Medium-risk teens will be offered monthly phone check-ins; medium-high risk teens will also be offered a chance to work with a therapist to create and use safety plans that spell out how teens can keep themselves safe and what they will do if they feel suicidal. Teens at the highest level of risk will also be offered DBT group therapy for six months. The second suicide prevention approach is called Zero Suicide (ZS) care. This program is used by many healthcare clinics, hospitals, and therapy centers across the United States. It encourages therapists and doctors to ask about suicide frequently, and to make sure that teens who are at risk of suicide are connected to the best health care available, which might be regular therapy, medications, or a combination of the two.

To determine who to include in this study, the team will use a computer program to predict the chance that a teen will make a suicide attempt in the next six months. This program uses data collected by the healthcare system and is about 85 percent accurate. Teens who are at medium or high risk of suicide based on the computer program will be assigned by chance, like the flip of a coin, to one of two suicide prevention approaches. The team will use healthcare and government databases to see what happens for teens over 12 months so the team can compare rates of suicide attempts, self-harm, and healthcare use.

The goal is to help teens to be treated in a way that allows them the most personal freedom. The results from this study will help health insurers and clinics decide what kinds of suicide prevention care to offer and to cover. They will also help doctors and therapists decide what approaches to recommend to patients, and help individual teens and their families decide what kind of care to receive. The team will share its results with researchers, healthcare organizations, and national groups that advocate for youth suicide prevention to make sure that they will have the information they need to make choices about the best suicide prevention options for all types of teens.

  • Lead Sites:
    • KPNW (Clinical Coordinating Center, co-PI Greg Clarke)
    • KPGA (Data Coordinating Center, co-PI Courtney McCracken)
  • Participating Sites:
    • KPWA (site PI Rob Penfold)
    • HealthPartners (site PI Rebecca Rossom)
    • Georgia State University (site PI Ashli Owen-Smith)
    • UCLA (site PI Joan Asarnow)
    • California State Lutheran University (Site PI Jamie Bedics)

Awarded Budget (total cost): $21,324,820

Funding Announcement

Personnel Contact List

Human Subjects: YES

Current status

Pilot testing of outreach and intervention delivery will begin in October 2022.

Summary of findings

Publications

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