Employing a Stepped-Wedge Design to Implement an Evidence-Based Psychotherapy for PTSD in Six Large, Diverse Health Care Systems

Grant Details

Funder: PCORI

Grant Number:

Project Period: 2022 – 2025

  • Lead Sites:
    • Yale (co-PI Joan Cook) and KPHI (co-PI Vanessa Simiola)
  • Participating Sites:
    • Henry Ford Health System (co-I Lisa Matero)
    • Kaiser Permanente Northwest (co-I Frances Lynch)
    • Kaiser Permanente Georgia (co-Is Ashli Owne-Smith, Kanetha Wilson, Courtney McCracken)
    • Essentia Health (co-I Melissa Harry)
    • Baylor Scott & White Health (co-I Katherine Sanchez)

Brief Narrative: Written Exposure Therapy (WET) is a five-session exposure-based EBP for PTSD that was efficacious in randomized controlled trials for treating PTSD from different types of traumas. In addition to PCORI’s recognition, WET is recommended as a first-line treatment by the Department of Veteran Affairs (VA) and the Department of Defense (DoD). In two recent trials, WET was non-inferior to the more time-intensive, gold-standard EBP, Cognitive Processing Therapy. Thus, WET seems to meet the need for alternative PTSD treatments that are brief, with little dropout, and require less clinical training. Indeed, WET’s brevity and tolerability make it an ideal first-level intervention, appealing to patients who have opted not to seek out more time- and therapist-intensive EBPs. WET addresses significant barriers to other EBPs for PTSD at the patient, provider, and system levels.

The project will employ a stepped wedge design to implement WET in six, large, diverse, integrated, civilian health care systems across the United States— Kaiser Permanente (KP) Hawaii, Henry Ford Health System, Kaiser Permanente Northwest, Kaiser Permanente Georgia, Essentia Health, and Baylor Scott & White Health — with all sites receiving the intervention during the project period. The healthcare systems are members of the Mental Health Research Network (MHRN), a consortium of 14 research centers. Sites will be assigned to one of two implementation groups. Every site will receive WET training, consultation, and multi-component implementation strategies, promoting equity and advancing the field of implementation science.

The specific aims of this project are to:

  1. Employ multi-component implementation strategies to help mental health providers implement WET for their PTSD patients in mental health settings in six health care systems.
  2. Use Consolidated Framework for Implementation Research (CFIR) to understand the determinants and process of implementation.
  3. Utilize RE-AIM framework to evaluate implementation outcomes for mental health providers and patients.

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

  1. 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          
  2. Dimidjian, Sona; Segal, Zindel V. Prospects for a clinical science of mindfulness-based intervention. The American psychologist 2015 Oct; 70 (7) 593-620       
  3. 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         
  4. 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

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

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

Telehealth: Assessing Services in Kaiser Permanente (TASK)

Grant Details

Title: Telehealth: Assessing Services in Kaiser Permanente (TASK)

Funder: Kaiser Permanente Research

Grant Number: KPR-HPHQ-2021-01

Grant Period: 07/01/2021 – 12/31/2022

Brief Narrative: There is considerable optimism that telehealth –especially telephone and video-based visits –can transform care delivery within Kaiser Permanente (KP) and across the United States. Mental Health and Wellness (MHW) is the service line with the greatest potential to realize the benefits of expanding telehealth and transfer learning across service lines and regions. This mixed-methods project will study the quality, efficiency, and value of MHW services in six KP regions using generalized estimating equations, predictive analytics, and semi-structured interviews with members, clinicians, and administrators. The work will advance KP’s national telehealth strategy and inform capital and operational investments by improving our understanding of clinical, technical, and legal barriers and facilitators to telehealth as well as by furthering our ability to measure telehealth encounters and the relationship between telehealth and face-to-face care.

  • Lead sites:
    • KPNW (Administrative lead site, Co-PI Greg Clarke)
    • KPWA (Scientific lead site, Co-PI Robert Penfold)
  • Participating sites
    • KPCO (Site PI Jennifer Boggs)
    • KPGA (co-Site PIs Teaniese Davis& Courtney McCracken)
    • KPHI (Site PI Yihe Daida)
    • KPSC (Site PI Corinna Koebnick)

Awarded budget (total cost): $998,145

Personnel Contact List

Human Subjects: NO. All participating sites’ IRBs made a determination of quality improvement.

Current Status

Analyses are ongoing. We are evaluating:

  1. Changes in depression treatment outcomes and follow-up care with the switch to virtual care
  2. Assessing the clinical content of unscheduled telephone visits and developing measures to differentiate meaningful clinical content at these visits.
  3. Interviewing clinicians and members about their experiences
  4. Developing an updated predicting model for “no-shows” in the new (mostly) virtual environment in specialty mental health care.

Summary of findings

Interim findings suggest that positive outcomes for depression treatment were not substantially reduced by the move to virtual care. Some differences in follow-up PHQ9 administration were observed by race/ethnicity.

Qualitatively, most KP members are happy (or happier) with virtual care because of its convenience. They report only minor differences in interacting with their providers. Moderate irritation with technical issues is pervasive.

Publications

None yet.

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

Behavioral Activation for Perinatal Depression

Project Name: 
Feasibility of Behavioral Activation for Perinatal Depression
Principal Investigator:
Arne Beck, PhD
Principal Investigator Contact Information:
arne.beck@kp.org
Principal Investigator institution:
Kaiser Permanente Colorado, Denver, CO
Funder:
NIMH
Funding Period:
07/2010 – 07/2014
Abstract:
At four MHRN sites (Group Health, HealthPartners, KP Colorado, and KP Georgia) women with moderate or greater symptoms of depression were identified either by visit-based screening (by OB clinic staff at first prenatal visits) or mailed screening (of all pregnant women during the first and/or second trimester).  Those identified were offered participation in a randomized trial comparing continued care as usual to Behavioral Activation (BA) Psychotherapy added to care as usual.  The BA program was adapted for the specific needs of mothers (including delivery by telephone) and for delivery by a range of clinicians (including OB clinical staff).  The project also took advantage of the MHRN’s centralized online survey platform for administration of standard assessments at baseline and follow-up.
Grant Number:
U19MH092201
Participating Sites:                                       
Kaiser Permanente Colorado, Denver, CO (Lead Site)
Group Health Cooperative, Seattle, WA
HealthPartners, Minneapolis, MN
Kaiser Permanente Georgia, Atlanta, GA
Investigators:
Arne Beck, PhD – KPCO
Sona Dimidjian, PhD – University of Colorado Boulder
Greg Simon, MD – GH
Nancy Sherwood, PhD – HP
Sherryl Goodman, PhD – KPGA
Evette Ludman, PhD – GH
Major Goals:
Demonstrate the feasibility of innovative and efficient methods for multi-site comparative effectiveness trials in mental health, using perinatal depression as an example, including: Screening for depression at the point of care and via low-cost mail and web surveysTraining real-world clinicians to deliver a structured behavioral activation intervention. Delivering a structured psychotherapy intervention via telephone contacts and in-person visitsAssessing outcomes via low-cost web-based interactive voice response surveys. In a population-based sample of pregnant women with current depression, conduct a randomized comparison of a structured Behavioral Activation intervention to care as usual in order to evaluate feasibility and acceptability – and make a preliminary comparison of effectiveness.
Description of study sample:
Women with moderate or greater symptoms of depression were identified either by visit-based screening (by OB clinic staff at first prenatal visits) or mailed screening (of all pregnant women during the first and/or second trimester).  Using various methods of recruitment, women were randomized into this study to usual care or to the intervention.  For all participating sites, 163 women participated in the randomized trial. Follow-up surveys were completed for all participating sites with the completion of the last 3-month post-partum surveys.  Only 9 participants out of the 163 women who were enrolled at all the sites were lost to follow-up (filled out the baseline but did not complete any follow-ups), 6 in the intervention group and 3 in the usual care group. 
Current Status:
Nurse practitioners, nurse midwives, and mental health therapists were trained to deliver 10 telephonic sessions of behavioral activation (BA) therapy to women screening positive for depression at prenatal visits who are randomized to the BA arm of the trial. An efficient web-based survey using the DatStat platform was developed and used to collect data on several measures from participants at enrollment, 5 and 10 weeks, and 3 months post-partum. 
Study Registration:
NCT01401231
Publications:
Dimidjian, S, Goodman, SH, Sherwood, NE, Simon, G, Ludman, S, Gallop, R, Welch, SS, Boggs, JM, Metcalf, CM, Hubley, S, Beck, A. (2016) A Pragmatic Randomized Clinical Trial of Behavioral Activation for Depressed Pregnant Women.  Journal of Consulting and Clinical PsychologyIn Press.
Resources:
N/A
Lessons Learned: The most efficient recruitment procedure was developed and implemented at HP, involving large mailings of PHQ9 surveys to women scheduled for prenatal visits. Recruitment is also being done at the point of care at KPCO, GHC, and KPGA, when women are given the PHQ9 or EPDS to assess their level of depression symptoms. Nurse practitioners and midwives can be trained to deliver BA with an acceptable level of fidelity. Telephonic BA is feasible and acceptable to participants. Compared to treatment as usual, patient randomized to the behavioral activation group, had significantly lower depressive symptoms and higher remission rates. Behavioral activation also showed significant reductions in symptoms of anxiety and perceived stress. 
What’s next?
Following this trials demonstration of the acceptability and effectiveness of behavioral activation delivered by allied health providers, the study teams approached the OB-GYN departments at each institution regarding implementation of a BA intervention in the OB-GYN setting.  While there was recognition of the effectiveness of the BA model for perinatal depression, implementation of an operation program was met with hesitancy regarding financial and logistical hurdles.  Specific barriers included a lack of continued funding for the BA clinicians employed during the study and coordination hurdles surrounding nurses or other allied health professionals taking time away from their current job roles to provide BA for women with depression.  Therefore, the study team took this feedback and Sona Dimidjian proposed a new study using peer specialists who would be trained in BA combined with research to practice engagement methods.  This R34 was funded in September, 2016 for 3 years.  The goals of this study are to engage all stakeholders in the design of a Peer BA intervention for perinatal and post-partum depression using research to practice frameworks to better facilitate successful adoption following the trial.   Stakeholders include patients, OB-GYN, Behavioral Health, and other relevant departments at KPCO.

Diversity Supplement – Understanding factors that lead to disparities in depression treatment

Project Name:
Diversity Supplement – Understanding factors that lead to disparities in depression treatment
Principal Investigator:
Karen J Coleman, PhD
Principal Investigator Contact Information:
Karen.J.Coleman@kp.org
Principal Investigator institution:
Kaiser Permanente Southern California
Funder
NIMH
Funding Period:  
09/2014 – 06/2016 (no-cost extension through 06/2017)
Abstract:
Depression and other mental illnesses lead to more disability than the most prevalent physical chronic illnesses such as heart disease, diabetes, and cancer, and may cost the U.S. healthcare system as much as 300 billion dollars annually. There are clear racial and ethnic differences in depression treatment, however, it is unknown if these are patient, provider, or healthcare system driven. The diversity supplement was designed to build on previous work funded within the Mental Health Research Network (MHRN) on practice variation in the treatment of depression. The original aims of the diversity supplement were as follows: Aim 1: To understand the healthcare system-, provider-, and patient-level factors that predict taking the initial antidepressant medication prescribed and/or attendance at the initial psychotherapy visit (primary adherence) within 30 days of an initial depression diagnosis.
Aim 2: To identify the healthcare system-, provider-, and patient-level factors that predict continuation of depression-related treatment once started (secondary adherence).
AIM 3: To characterize racial/ethnic disparities in the achievement of depression improvement or remission with treatment as assessed with the patient health questionnaire (PHQ9), and to understand the role of adherence in this response to treatment.
Grant Number:  
U19MH092201 (Supplement under MHRN II)
Participating Sites Contributing Data:
Kaiser Permanente Southern California, Pasadena, CA
Group Health Cooperative, Seattle, Washington
HealthPartners Institute, Minneapolis, Minnesota
Kaiser Permanente Colorado, Denver, Colorado
Kaiser Permanente Hawaii, Honolulu, Hawaii
Henry Ford Healthcare Systems, Detroit, Michigan
Additional Sites Participating in the Study:
Baylor Scott & White, Temple, Texas
University of Utah, Salt Lake City, Utah
Investigators:
Karen J. Coleman, PhD
Gregory Simon, MD MPH
Rebecca Rossom, MD
Arne Beck, PhD
Beth Waitzfelder, PhD
John Zieber, PhD
Brian Ahmedani, PhD
Zach Imel, PhD
Major Goals: To provide a high-level understanding of how race/ethnicity contributes independently to the variation for initiation and continuation of depression treatment. To provide a dataset and documentation associated with this dataset and its analyses that can be used by other researchers interested in the treatment of depression in large healthcare systems. To provide a basis for testing culturally tailored or appropriate interventions that improve the adherence to depression treatment in a variety of patient populations.
Major Limitations: Questions about depression treatment outcomes cannot be addressed with this dataset because PHQ9 data collection in the five healthcare systems during the study period was not widespread. Questions about healthcare system variation in policies and guidelines for depression treatment cannot be addressed with this dataset as these variables were not available for study. Questions about provider-level variation in the treatment of depression can only be addressed for two sites in the study due to the lack of data collected for providers in the other sites. Thus, conclusions about provider-level variation and its contribution to depression treatment modalities and adherence cannot generalize to other healthcare settings.
Description of study sample:
There are two study samples included in this study. One is for initiation of treatment for patients newly diagnosed with depression and one is for adherence to a new episode of antidepressant medication and/or formal psychotherapy treatment in patients diagnosed with depression. Treatment in the Newly Diagnosed Patients 18 and older who had a new depression diagnosis in primary care clinics between 1/1/2009 and 12/31/2013 were included. Patients were excluded if they had a diagnosis of bipolar disorder, schizophrenia spectrum disorder, or other psychosis in the prior two years to the diagnosis date. To ensure the availability of data needed to create the patient sample for all analyses, the sample was limited to those who were continuously enrolled in the healthcare systems for at least 360 days prior to the diagnosis date, allowing a 60-day gap. New episodes of depression were defined as an ICD-9 code for depression made in a primary care setting, with no diagnosis or treatment for depression (either psychotherapy or antidepressant medication) during the 360 days prior to the diagnosis. These patients were followed for 90 days after the diagnosis date to look for the initiation of treatment (see definitions below for treatment). Patients who disenrolled from the healthcare systems in less than 90 days after diagnosis were excluded. Adherence in the Newly Treated
Patients 18 and older who had a new episode of formal psychotherapy treatment (PT) between 1/1/2010 and 12/31/2013 or a new antidepressant treatment (AD) between 1/1/2010 and 12/31/2013 were included. Patients were excluded if they had a diagnosis of bipolar disorder, schizophrenia spectrum disorder, or other psychosis in the prior two years to index date. The sample was also limited to those who were continuously enrolled in the healthcare systems for at least 270 days prior to the index AD/PT episode, allowing a 60-day gap. A new episode of AD/PT treatment was defined as not having any evidence of the same type of treatment (AD or PT) during the previous 270 days before the date of the new episode.  AD episodes with a prescription for trazodone were excluded because this drug is primarily prescribed for sleep disturbance and not depression. We did not consider appointments that were less than 30 minutes and/or clearly designated as only medication management to be formal psychotherapy.
Current Status:
The analytic dataset and its documentation have been compiled.  Further analyses funded by the project are limited to the following manuscripts which are currently in process: The Mental Health Provider as a Source of Racial and Ethnic Disparities in Adherence to Antidepressant Medication and Psychotherapy (Imel et al.)
Study Registration:
N/A
Publications: Coleman KJ, Stewart C, Waitzfelder BE, Zeber JE, Morales LS, Ahmed AT, Ahmedani BK, Beck A, Copeland LA, Cummings JR, Hunkeler EM, Lindberg NM, Lynch F, Lu CY, Owen-Smith AA, Trinacty CM, Whitebird RR, Simon GE. Racial-Ethnic Differences in Psychiatric Diagnoses and Treatment Across 11 Health Care Systems in the Mental Health Research Network. Psychiatr Serv. 2016 Jul 1;67(7):749-57. doi: 10.1176/appi.ps.201500217. Epub 2016 Apr 15.Rossom RC, Shortreed S, Coleman KJ, Beck A, Waitzfelder BE, Stewart C, Ahmedani BK, Zeber JE, Simon GE. Antidepressant adherence across diverse populations and healthcare settings. Depress Anxiety. 2016 Aug;33(8):765-74. doi: 10.1002/da.22532. Epub 2016 Jun 20.Simon GE, Coleman KJ, Waitzfelder BE, Beck A, Rossom RC, Stewart C, Penfold RB. Adjusting Antidepressant Quality Measures for Race and Ethnicity. JAMA Psychiatry. 2015 Oct;72(10):1055-6. doi: 10.1001/jamapsychiatry.2015.1437.Simon GE, Rossom RC, Beck A, Waitzfelder BE, Coleman KJ, Stewart C, Operskalski B, Penfold RB, Shortreed SM. Antidepressants are not overprescribed for mild depression. J Clin Psychiatry. 2015 Dec;76(12):1627-32. doi: 10.4088/JCP.14m09162.Zeber JE, Coleman KJ, Fischer H, Yoon TK, Ahmedani BK, Beck A, Hubley S, Imel ZE, Rossom RC, Shortreed SM, Stewart C, Waitzfelder BE, Simon GE. The impact of race and ethnicity on rates of return to psychotherapy for depression. Depress Anxiety. 2017 Dec;34(12):1157-1163. doi: 10.1002/da.22696. Epub 2017 Nov 2. PubMed PMID: 29095538; PubMed Central PMCID: PMC5718939.Waitzfelder B, Stewart C, Coleman KJ, Rossom R, Ahmedani BK, Beck A, Zeber JE, Daida YG, Trinacty C, Hubley S, Simon GE. Treatment Initiation for New Episodes of Depression in Primary Care Settings. J Gen Intern Med. 2018 Aug;33(8):1283-1291. doi: 10.1007/s11606-017-4297-2. Epub 2018 Feb 8. PubMed PMID: 29423624.
Resources:
A data dictionary and descriptive tables for the data file associated with this project will be available soon. Some research questions cannot be addressed by this dataset and require an initial review and possible discussion to make this determination. For immediate questions, contact Greg Simon at simon.g@ghc.org.
Lessons Learned:
For all systems contributing data to this project, electronic medical records, insurance claims, and other data systems were organized in a Virtual Data Warehouse (VDW) to facilitate population-based research. The VDW is a collection of common data definitions and formats to ensure equivalent de-identified data for analysis. Because the VDW relies on data availability from a diverse set of healthcare settings in the Health Care Systems Research Network customizing data abstraction such as healthcare system policy variables or provider-level descriptive information is difficult and in some cases impossible. This needs to be considered when studies are proposed that examine the interplay of healthcare system-, provider-, and patient-level factors in mental health-related treatment choices and outcomes.
What’s next?
Possible harvest of new PHQ9 data as implementation of screening and treatment follow-up have increased exponentially since 2013. Pursue an R01 to characterize heterogeneity of achievement of depression improvement or remission and incorporate more healthcare sites (only 6 of 13 MHRN sites were included) and use additional provider variation analytic methods. Other possible grant ideas that have been discussed: Culturally-tailored intervention to assist with the decisions around depression treatment (shared decision-making and motivational interviewing models)

Practice Variation in High- and Low-value Care for Mood Disorders

Project Name:
Practice Variation in High- and Low-Value Care for Mood Disorders
Principal Investigator:
Gregory Simon MD MPH
Principal Investigator Contact Information:
simon.g@ghc.org
Principal Investigator institution:
Group Health Research Institute
Funder
NIMH
Funding Period:
09/2010 – 06/2015
Abstract:
This multi-site observational study examined patient, provider, and health system influences on process of depression care in primary care and mental health specialty settings.  Comprehensive records data from five MHRN sites (Group Health Cooperative, HealthPartners, Kaiser Permanente Colorado, Kaiser Permanente Hawaii, and Kaiser Permanente Southern California) were used to identify three patient cohorts: Primary care patients receiving a new diagnosis of depression with no recent history of depression treatment. Primary care and mental health specialty patients initiating a new episode of antidepressant treatment with a diagnosis of depression. Mental health specialty patients initiating a new episode of psychotherapy with a diagnosis of depression
Grant Number:
U19 MH092201 (Mental Health Research Network Cooperative Agreement)
Participating Sites:               
Group Health Cooperative                                                     
HealthPartners Institute                                
Kaiser Permanente Colorado                        
Kaiser Permanente Hawaii
Kaiser Permanente Southern California        
Investigators:
Gregory Simon MD MPH
Robert Penfold PhD
Susan Shortreed, PhD
Rebecca Rossom MD
Arne Beck PhD
Beth Waitzfelder PhD
Karen Coleman PhD
Major Goals:
To examine patient and provider contributions to variation in care (medication and psychotherapy) for depression.
Description of study sample:
The sample includes new diagnoses and new treatment episodes between 1/1/2010 and 12/31/2012.  These data are being used to address the following specific questions: Among primary care patients receiving a new diagnosis of depression, how do specific patient characteristics (age, sex, race/ethnicity, severity of depression) influence both the likelihood of initiating any treatment for depression and the choice between treatments (medication or psychotherapy)Among patients initiating medication treatment for depression, how are medication selection, early medication adherence, and acute-phase treatment response related to specific patient characteristics (age, sex, race/ethnicity, severity of depression)?  How do these treatment processes vary among providers? Among patients initiating psychotherapy for depression, how are early treatment adherence and acute-phase treatment response related to specific patient characteristics (age, sex, race/ethnicity, severity of depression)?  How do these treatment processes vary among providers?
Current Status:
All analyses are complete.
Study Registration:
N/A
Publications:
Simon GE, Coleman KJ, Waitzfelder BE, Beck A, Rossom RC, Stewart C, Penfold RB. Adjusting Antidepressant Quality Measures for Race and Ethnicity. JAMA Psychiatry. 2015 Oct;72(10):1055-6. doi: 10.1001/jamapsychiatry.2015.1437. No abstract available. PMID:26352783Simon GE, Rossom RC, Beck A, Waitzfelder BE, Coleman KJ, Stewart C, Operskalski B, Penfold RB, Shortreed SM.J. Antidepressants are not overprescribed for mild depression. Clin Psychiatry. 2015 Dec;76(12):1627-32. doi: 10.4088/JCP.14m09162.PMID:26580702Simon GE, Johnson E, Stewart C, Rossom RC, Beck A, Coleman KJ, Waitzfelder B, Penfold R, Operskalski BH, Shortreed SM.  Does patient adherence to antidepressant medication actually vary between physicians?  J Clin Psychiatry.  2017 Oct 24 (epub ahead of print)
Resources:
None
Lessons Learned: In MHRN health systems, we see little evidence for over-prescribing of antidepressants for mild depression. Likelihood of prematurely discontinuing antidepressant medication is much higher in minority racial and ethnic groups than in non-Hispanic Whites, and these racial and ethnic differences are far larger than differences related to other demographic or clinical characteristics. Likelihood of prematurely discontinuing psychotherapy for depression is modestly higher in minority racial and ethnic groups – but racial/ethnic disparities in psychotherapy adherence are smaller than disparities in antidepressant medication adherence. Among primary care patients receiving a new diagnosis of depression, likelihood of initiating any specific treatment (medication or psychotherapy) is lower among minority racial or ethnic groups.  Patients from minority racial and ethnic groups are more likely to start psychotherapy than medication. Failure to adjust antidepressant treatment quality measures for race and ethnicity will significantly disadvantage health systems serving members from traditionally under-served racial and ethnic groups. After accounting for random variation, likelihood of prematurely discontinuing antidepressant medication varies only minimally across physicians.
 What’s next?
A follow-up study (funded during the second cycle of MHRN funding) will further explore racial and ethnic disparities in care identified in this project.