eHealth and mHealth

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

Mindfulness-based cognitive therapy for prevention of perinatal depression

Grant Details

Funder: NIMH

Grant Number: R34MH083866

Grant Period: 9/17/2008 – 7/31/2012

Brief Narrative: This study will investigate the feasibility, safety, acceptability, and preliminary efficacy of a brief, group intervention designed to prevent perinatal depression (PD). We will develop and evaluate a behavioral preventive intervention based on Mindfulness-Based Cognitive Therapy (MBCT), which has been found to significantly reduce rates of relapse of recurrent depression among general adult samples and has high relevance to the prevention of PD. MBCT is non-pharmacological, offers an alternative to traditional one-on-one care models, and is based on a clear conceptual and empirical relationship between the specific intervention strategies and the most robust risk factor for perinatal depression, namely depressive history. The project will involve 3 phases, implemented in 2 obstetric settings: 1) conceptualizing the intervention based on theory and empirical research (MBCT for perinatal depression; MBCT-PD), 2) developing and standardizing MBCT-PD, and 3) pilot testing its efficacy in preventing relapse and recurrence among perinatal women with histories of depression. Phase 1 work is already under way. In Phase 2, we propose an open-trial to develop the MBCT-PD program (N=20). Based on an iterative process, we will finalize a participant- and expert informed manual for MBCT-PD that is sensitive and specific to the developmental factors associated with PD. In Phase 3, we propose to test MBCT-PD in a pilot randomized controlled trial comparing MBCT-PD to Treatment-as-Usual (TAU) (N=160). We will test the primary hypothesis that participants receiving MBCT-PD will experience improved depressive outcomes compared to participants receiving TAU, including testing group differences in rates of relapse/recurrence and exploring group differences in depressive symptom severity. We will also explore group differences in secondary outcomes, including anxiety and stress and obstetrical complications, and will explore potential moderators and mediators of depression outcomes. Finally, we will train and evaluate the ability of behavioral health care providers to administer the MBCT-PD program with fidelity. Given the negative and enduring consequences of untreated perinatal depression for women and their children, low rates of treatment seeking, and concerns associated with pharmacological approaches, the development and ongoing investigation of MBCT-PD may have significant benefits for women, children, and society at large

Lead Site: University of Colorado (PI Sona Dimidjian)

Participating Sites: KPCO, Emory University

Current Status

Summary of Findings

Publications

Dimidjian, Sona; Goodman, Sherryl H; Felder, Jennifer N; Gallop, Robert; Brown, Amanda P; Beck, Arne. Staying Well during Pregnancy and the Postpartum: A Pilot Randomized Trial of Mindfulness Based Cognitive Therapy for the Prevention of Depressive Relapse/Recurrence. Journal of consulting and clinical psychology 2016 Feb; 84 (2) 134-45
Dimidjian, Sona; Segal, Zindel V. Prospects for a clinical science of mindfulness-based intervention. The American psychologist 2015 Oct; 70 (7) 593-620
Dimidjian, Sona; Goodman, Sherryl H; Felder, Jennifer N; Gallop, Robert; Brown, Amanda P; Beck, Arne. An open trial of mindfulness-based cognitive therapy for the prevention of perinatal depressive relapse/recurrence. Archives of women’s mental health 2015 Feb; 18 (1) 85-94
Goodman, Sherryl H; Dimidjian, Sona. The developmental psychopathology of perinatal depression: implications for psychosocial treatment development and delivery in pregnancy. Canadian journal of psychiatry. Revue canadienne de psychiatrie 2012 Sep; 57 (9) 530-6

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 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

Next Generation Assessment Using Mobile Devices

Project Name:
Mobile Assessment Pilot: Next Generation Assessment Using Mobile Devices

Principal Investigator:
Gregory Clarke, PhD

Principal Investigator Contact Information:
Greg.Clarke@kpchr.org

Principal Investigator institution:
Kaiser Permanente Northwest

Funder:
NIMH

Funding Period:
08/2014 – 07/2017

Abstract:
The constructs of cognitive control, emotional processing, attentional and negativity bias, physical and social engagement are specific and measurable characteristics that may aid in the selection of optional acute treatment for depression and anxiety. Methods to assess these constructs either passively or with very low burden/cost have advanced significantly, such that they are now readily available through mobile devices such as smart phones, tablets and wearable sensors. Given that over 120 million people in the US own a mobile device, the practical utility of these assessment tools for compiling important clinical information is high, and the potential for data from these devised to inform clinical practice especially compelling.

Grant Number:
U19MH092201

Participating Sites:
Kaiser Permanente Northwest, Portland, OR (Lead Site)
University of Washington, Seattle, WA
Kaiser Permanente Georgia, Atlanta, GA

Investigators:
Gregory Clarke, PhD
Patricia Arean, PhD
Ashli Owen-Smith, PhD

Major Goals:
The purpose of this pilot project is to assess consumer engagement, predictive utility, and clinical applicability of mobile, IT-enabled assessment of cognitive, physical and social activity in patients seeking treatment for depression and anxiety.

Description of study sample:
We will recruit 75 members per performance site, for a total of 150 members. Members will be 18 and older, English-speaking, own a smart device (iOS operating system). We will recruit members who have had a recent dispense of an anti-depressant medication.

Current Status:
Enrollment is currently closed, and data collection is complete. We are currently summarizing data collected from qualitative interviews with providers and members to include in our analyses. We are also conducting quantitative analyses on the predictive utility of these mobile health apps. We are writing manuscripts for both sets of results.

Study Registration:
N/A

Publications:
N/A

Resources
N/A

Lessons Learned:
Recruitment was much more difficult than initially expected. We had an overall enrollment rate of approximately 3% between the two sites. Likewise, we had somewhat low engagement with participant usage of the study apps. We believe this is mostly due to the design of the study, where all recruitment and study activities are completed remotely and there is no direct contact with participants.

What’s next?
We have finished conducting quantitative analyses on the predictive utility of these mobile health apps and summarize the responses from the qualitative interview data. We are now writing a manuscript with the results from these analyses and from the quantitative data collected as part of the study.

Pragmatic Trial of Population-based Programs to Prevent Suicide Attempt

Project Name:
Pragmatic Trial of Population-based Programs to Prevent Suicide Attempt

Principal Investigator:
Greg Simon, MD, MPH

Principal Investigator Contact Information:
Gregory.E.Simon@kp.org

Principal Investigator institution:
Kaiser Permanente Washington

Funder
NIMH

Funding Period:
09/2014 – 07/2020

Abstract:
Suicide ranks 10th among all causes of mortality in the US, accounting for over 38,000 deaths in 2010. Non-fatal suicide attempts result in 600,000 emergency room visits and nearly 200,000 hospitalizations each year. Recent developments have opened new opportunities to develop and evaluate population-based selective prevention programs for suicidal behavior. First, increasing use of standard depression severity measures and recording of results in electronic medical records will allow timely and efficient identification of people at risk for suicidal behavior. Second, efficient and scalable interventions (both structured risk assessment/care management programs and low-intensity emotion regulation skills training) have shown promise for reducing risk of suicide attempt in at-risk populations. Third, the NIMH-funded Mental Health Research Network has established an infrastructure to adequately evaluate population-based prevention. We will conduct a large, pragmatic trial to examine two specific selective prevention programs. Both programs are based in a re-conceptualization of suicidal ideation as an enduring vulnerability rather than a short-term crisis. The trial will be conducted in 4 large, integrated health care systems. We propose to enroll up to 19,500 adults for whom responses to item 9 of the PHQ depression scale (regarding thoughts of death or suicide) indicate elevated risk. Participants will be randomly assigned to continued usual care or usual care supplemented by one of the two prevention programs: An outreach and care management program (via secure messaging and telephone) including structured assessment linked to specific care pathways. An online psychoeducational program focused on development of emotion regulation skills and prevention of suicidal behaviors, supported by coaching to promote engagement and adherence. Both programs are supplements to usual care. Both programs will capitalize on existing electronic records to improve efficiency and assure quality. The primary outcome will be suicide attempt (fatal or non-fatal) during 18 months following enrollment – ascertained automatically from computerized records. A pragmatic trial of selective prevention would fill a major gap in current suicide prevention efforts. Methods developed in this trial should dramatically accelerate future suicide prevention research.

Grant Number:
UH3007755

Participating Sites:
Kaiser Permanente Washington
Kaiser Permanente Northwest
Kaiser Permanente Colorado
HealthPartners

Investigators:
Greg Simon, MD
Rebecca Rossom
Arne Beck
Greg Clarke

Major Goals:
To conduct a large, pragmatic trial to examine two population-based programs to prevent suicide attempt. Participants will be randomly assigned to continued usual care or usual care supplemented by one of the two prevention programs: an outreach and care management program (via secure messaging and telephone) including structured assessment linked to specific care pathways, or an online psycho-educational program focused on development of emotion regulation skills and prevention of suicidal behaviors, supported by coaching to promote engagement and adherence. The primary outcome will be suicide attempt (fatal or non-fatal) during 18 months following enrollment – ascertained automatically from computerized records. The trial will be conducted in 4 health systems: Kaiser Permanente Washington, Kaiser Permanente Colorado, Kaiser Permanente Northwest and HealthPartners.

Description of study sample:
Adult outpatients who completed a PHQ depression questionnaire in the previous week and reported thoughts of death or self-harm “most of the days” or “nearly every day.”

Current Status:
A total of 18,887 participants were enrolled, intervention procedures will continue through Fall 2019.

Study Registration:
NCT02326883

Publications:
Shortreed SM, Rutter CM, Cook AJ, Simon GE. Improving pragmatic clinical trial design using real-world data. Clin Trials. 2019 Jun;16(3):293-282.

Simon GE, Beck A, Rossom RC, Richards JR, Kirlin B, Shulman L, King D, Ludman EJ, Penfold R, Shortreed SM, Whiteside US. Population-Based Outreach Versus Care As Usual To Prevent Suicide Attempt: Study Protocol for a Randomized Controlled Trial. Trials. 2016 Sep 15;17(1):452.Whiteside U, Lungu A, Richards J, Simon GE, Clingan S, Siler J, Snyder L, Ludman E. Designing messaging to engage patients in an online suicide prevention intervention: survey results from patients with current suicidal ideation. J Med Internet Res. 2014 Feb 7;16(2):e42.

Resources: Specifications for defining suicide attempts are available at: https://github.com/MHResearchNetwork/MHRN-Central

Lessons Learned:
Transferring registry tools between health system Epic EMRs was more complicated than anticipated.

What’s next?
The target for completing primary analyses is Summer 2020.