Depressive disorders

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

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

Treatment Initiation for New Episodes of Depression in Pregnant Women

Grant Details

Funder: NICHHD

Grant Number: R01HD100579

Grant Period: 5/6/2021 – 3/31/2026

Narrative: Up to 12% of pregnant women have a new episode of depression, ie, an incident or recurrent depressive episode with symptom onset during pregnancy. Effects of untreated antenatal depression include unhealthy maternal behaviors (eg, diminished self-care, smoking, substance use, self-harm) and emotional and behavioral problems in offspring. Antenatal depression or elevated depression scores, identified by screening instruments, increase the risk of preterm birth (PTB), low birth weight (LBW), and small for gestational age (SGA) birth, and are associated with breastfeeding discontinuation before 3 months postpartum. In-person psychotherapy and antidepressant medication improve depression symptoms in many with depression, yet <50% of pregnant women with new episodes of depression initiate these treatments. Although some barriers to initiating antidepressants and psychotherapy are known, other factors have not been well described, especially after accounting for depression severity. Furthermore, the impact of antidepressants and psychotherapy on perinatal outcomes, including PTB, LBW, SGA, and breastfeeding continuation among pregnant women with new episodes of depression after accounting for confounding by depression severity is unknown. Given the importance of factors influencing the decision to initiate antidepressant or psychotherapy treatment during pregnancy and the need for further evidence on the perinatal risks and benefits associated with antidepressant use and psychotherapy in pregnant women, the goal of this study is to identify predictors and perinatal effects of psychotherapy and antidepressant use for new episodes of depression during pregnancy while accounting for depression severity. We will conduct this study in a racially and ethnically diverse multi- site population using electronic health data, enriched with survey data from a subset of women. Among pregnant women with new episodes of depression, we will evaluate factors that influence the propensity to initiate psychotherapy or antidepressants; accounting for these is crucial when studying treatment effects. We will describe patterns of use of alternative depression management approaches (eg, Internet- based psychotherapy, peer support groups, and complementary and alternative medicine) and will evaluate whether initiation of psychotherapy or antidepressants is associated with these practices while accounting for depression severity. We will quantify the impact of psychotherapy and antidepressants (including dose, timing, and duration of use) on PTB, LBW, SGA, and breastfeeding continuation accounting for the propensity to initiate psychotherapy or antidepressants and depression severity. We are uniquely positioned to overcome limitations of confounding and small size in prior studies given our data on depression severity and maternal comorbidity for more than 8,000 pregnant women. Our study will be informative for understanding the mental health interventions utilized by pregnant women with depression and will inform decision making on optimal depression management during pregnancy.

Lead site:
- HPI (PI Kristin Palmsten)

Participating Sites:
- HFHS
- KPHI
- KPNC
- KPSC

Current Status:

We are currently conducting the first aim of the study, which is a survey among people with new episodes of depression during pregnancy. We aim to learn about the treatments and strategies participants used to manage new episodes of depression during pregnancy, how they are supported by others, and how they feed their new babies. The survey also asks about childhood and life experiences. We completed a pilot survey at HealthPartners this spring and we are launching the survey across all sites this fall.

Summary of Findings:

None yet

Publications:

None yet

Weight loss and perinatal depression

Grant Details

Funder: NIMH (MHRN III Feasibility Pilot Program)

Grant Number: U19MH121738

Project Period: 7/1/2021 – 6/30/2022

Narrative:

Background: Rates of overweight (body mass index (BMI)=25.0-29.9kg/m2) and obesity (BMI>30.0kg/m2) among adult American women have continuously increased for the past 20 years, with 41.9% having obesity in 20181. Obesity is a risk factor for adverse outcomes in the 85% of women who become pregnant by age 442. Most women are advised to lose weight prior to becoming pregnant, to help alleviate several pregnancy and postpartum complications3. One of these complications is the development of prenatal and postpartum mental health disorders, including depression and anxiety4. Around 10-25% of mothers will experience depression during pregnancy5 and 10-15% in the postpartum period6. Between 0.9%−22.7% of mothers will experience generalized anxiety disorder during pregnancy7 and 4.4-8.5% postpartum8. Mothers who were overweight or obese at time of pregnancy appear to have higher risk for the development of postpartum depression and anxiety compared to their normal weight counterparts9.

In the general population, losing weight, defined as losing at least 5-10% of one’s body weight10, has produced mixed results in terms of changes in mental health symptoms. Some evidence indicates weight loss is associated with improved depressive11 and anxiety symptoms12, while others have found that weight loss was associated with increased depression symptoms13 and no association with anxiety14. However, no studies have examined how the process of losing weight prior to pregnancy interacts with the development of prenatal and postpartum mental health disorders. There is also evidence that the burden of obesity15 and postpartum depression and anxiety17 is greater in African-Americans and Latina mothers compared to White mothers, suggesting racial identity may moderate the relationship between weight loss and prenatal and postpartum mental health outcomes.

This project is responsive to the NIMH strategic goal “Strengthen the Public Health Impact of NIMH-Supported Research” by identifying specific groups of individuals who may have an elevated risk for developing depression and anxiety, and specific time points (prenatal or postpartum) that may be most vulnerable to psychopathology in a large, population level dataset. By identifying these individuals and timepoints, empirically-supported interventions can be implemented and tested for efficacy in a targeted manner.

Research Question: In a cohort of women 20 to 44 years of age who have obesity and are free of a diagnosis of depression or anxiety for a year prior to pregnancy, this study aims to:

1) determine if patients who experience successful weight loss (losing at least 10% of one’s body weight) vs. those who do not, in the year prior to pregnancy, have a lower risk for new onset prenatal and postpartum depression and anxiety.

2) Determine if the magnitude of association between pre-pregnancy weight loss and prenatal and postpartum depression and anxiety is greater in African-American and Latina women compared to White women.

Methods: The study will pull data from the electronic health record system of a large Midwestern hospital system and create a sample by identifying women of reproductive age (20- 44 years old) who experienced a live birth, and have a weight recorded sometime in the year prior to pregnancy. Case-matched samples will be created based on important demographics, such as insurance status and age, and clinical factors, including BMI at time of pregnancy. These samples will be divided into two groups: those who successfully lost weight prior to pregnancy and those who did not. The research questions will be analyzed using modified Poisson models.

Planned Product: The results of this study will be published and presented at a conference. Findings will provide preliminary evidence to support an R01 submission that will involve multi- HCSRN sites. Aims of the R01 submission will be expanded to examine dose response relationships in baseline BMI and pre-natal and post-partum depression and anxiety disorder and will determine if weight loss thresholds (moving from obese to overweight vs. obese to normal weight) are associated with greater reduction in risk for prenatal and postpartum depression.

Lead Site: St. Louis University (Co-PIs Megan Ferber and Kara Christopher)

Participating Sites: N/A

Current Status:

Summary of Findings:

Publications:

PHQ9 Differential Item Functioning

Grant Details

Funder: NIMH (MHRN III Feasibility Pilot Program)

Grant Number: U19MH121738

Project Period: 7/1/2020 – 6/30/2021

Narrative:

Background: Depression and suicide screeners like the Patient Health Questionnaire 9 (PHQ-9) are widely employed within healthcare systems in the U.S. as part of measurement-based care. Some research suggests the full or partial cross-cultural equivalence of the PHQ-9 among different racial and ethnic groups, including the standard one-factor model (Harry & Waring, 2019; Keum, Miller, & Kurotsuchi Inkelas, 2018; Merz et al., 2011; Patel et al., 2019), although in some cases two-factor models have presented the best fit (Granillo, 2012; Harry & Waring, 2019; Harry, Coley, Waring, & Simon, under review; Keum et al., 2018). Findings of cross-cultural equivalence allows for meaningful comparisons to be made in scale mean scores between different cultural groups. However, research has also shown the differential item functioning for some PHQ-9 items based on race (Huang et al., 2006). Furthermore, little cross-cultural research is available on the PHQ-9 that includes American Indian/Alaska Native people (AI/AN) (Harry & Waring, 2019; Harry et al., under review). This is even though AI/AN people have a higher rate of suicide than the general population (Curtin & Hedegaard, 2019) and few studies have researched depression prevalence among this group (Garrett et al., 2015). While available evidence suggests elevated depression rates amongst AI/AN people, most research has focused on individual tribal groups, and the little research that has included national samples has primarily only included those who identify solely as AI/AN and not additional racial or ethnic groups (Asdigian et al., 2018). Depression prevalence may differ between sub-populations of AI/AN people (Asdigian et al., 2018). Mental and behavioral health scales may also function differently between separate tribal or cultural AI/AN groups (Walls et al., 2018).

Recent studies have begun to fill the gap on the cross-cultural equivalence of the PHQ-9 with AI/AN people. Current findings have been mixed, including the study by Harry and Waring (2019) with a general patient population and another study by Harry et al. (under review) that included only those with mental health or substance abuse disorder diagnoses, suggesting that more research is needed. It is unknown if any individual PHQ-9 items function differently between AI/AN people and other racial and ethnic groups (Harry et al., under review). Both researchers and clinicians would benefit from understanding how individual PHQ-9 items function for different groups of AI/AN people and in comparison to other diverse racial and ethnic groups. This is a timely opportunity to extend our work by leveraging the findings from our prior research in this area, focus more closely on the functioning of item 9 between racial and ethnic groups, as well as develop additional preliminary results for a future R01 grant application.

This project supports the NIMH strategic goal of striving for prevention and cures. It does so by focusing on the cultural context component of developing strategies for tailoring existing interventions to optimize outcomes.

Research Question: In a patient population with mental health or substance abuse disorder diagnoses, how do individual PHQ-9 items function for AI/AN adults and other diverse racial and ethnic groups?

Methods: The differential item functioning of PHQ-9 items would be assessed using item response theory, or how different groups with differing levels of depression endorse PHQ-9 items. We would compare two geographically and culturally distinct groups of AI/AN adults (ages 18 to 64), as well as groups of Hispanic, non-Hispanic Native Hawaiian/Pacific Islander, non-Hispanic White, non-Hispanic Black, and non-Hispanic Asian adults. This study would be conducted using existing data from prior research and therefore would not require additional analyst support. The project has already been approved by the Essentia Health Institutional Review Board.

Planned Product: The primary product would be a paper presenting our results. Those results would also provide additional preliminary data for a series of broader, multi-MHRN site NIH grant applications on the cross-cultural assessment of depression and suicide risk and culturally competent interventions for AI/AN people and other indigenous groups, like Native Hawaiians. Collaboration with local tribal communities and researchers would be emphasized.

Lead Site: Essential Rural Health Institute (PI Melissa Harry)

Participating Sites: N/A

Current Status

Paper is under review with Psychological Assessment as of 10/12/2022.

Summary of Findings

Publications

Improved tailoring of depression care using customized clinical decision support

Grant Details

Funder: NIMH

Grant number: R01MH114873

Grant period: 07/01/2018 – 04/30/2023

Narrative: Treatments for mental health conditions such as unipolar depression provide modest average benefit but have wide variation between individuals and within individuals over time. Evidence-based customized treatment protocols would improve the mental health care of many people by providing treatment recommendations for individuals that take into account potential variation because of personal characteristics such as current health status, symptoms, and response to earlier treatment. Generating customized treatment protocols requires large amounts of data, such as from networks of health systems that can link electronic health records from millions of individuals. Current statistical approaches for discovering customized treatment protocols are limited in three important ways. First, current approaches rely on scientists to select the patient characteristics to use to customize treatments instead of using data to find the patient characteristics that will lead to improved, customized care. Second, customized treatment protocols discovered with current statistical methods assume no unobserved differences between individuals who receive various treatment options. Third, investigators do not have ways to know if the available data contain enough information to discover and compare customized treatment protocols precisely enough to make clinical decisions. We will address these three limitations by developing new statistical tools for discovering customized treatment protocols using electronic health records data. Our research team has expertise and experience in statistics, epidemiology, and mental health care. We will integrate methods that have been successfully used in other settings to improve statistical approaches for discovering customized treatment protocols and address these three important limitations. We will extend machine learning tools for selecting important pieces of information to the time-varying data structure required for discovering customized treatment protocols. We will build approaches that use available knowledge about the size of unobserved differences between groups of people who received different treatments to assess how those differences change study results. By building on the math used to estimate the sample sizes needed for precision in randomized trials with complex designs, we will develop new formulas for determining how many people with a particular condition and who took a particular drug are needed in a health system to provide enough accurate information to discover customized treatment protocols. Using data from the electronic health records of more than 15,000 patients, we will discover customized treatment protocols for depression. By improving statistical tools and addressing current limitations, our customized treatment protocols will have immediate impact for people living with unipolar depression. The statistical tools we develop will also be useful for discovering customized treatment protocols for people with a wide variety of mental health conditions.

Lead site: KPWA (PI Susan Shortreed)

Participating site: McGill University (co-I Erica Moodie)

Funder contacts:
- Program Official: Michael Freed

Current Status

We have published papers proposing approaches to sample size estimation, unmeasured confounding sensitivity analyses, and selecting tailoring variables. We are continuing to work on alternative methods for tailoring variable selection.

Summary of Findings

Shrinkage regression based methods can identify important tailoring variables
Distributed regression methods can optimize individual treatment rules while protecting individual privacy
Dynamic weighted survival modeling can identify more effective individualized antidepressant treatment strategies using health records data

Publications

Coulombe J, Moodie EEM, Shortreed SM, Renoux C. Can the Risk of Severe Depression-Related Outcomes Be Reduced by Tailoring the Antidepressant Therapy to Patient Characteristics? Am J Epidemiol. 2021 Jul 1;190(7):1210-1219. doi: 10.1093/aje/kwaa260. PMID: 33295950; PMCID: PMC8245894.
Bian Z, Moodie EEM, Shortreed SM, Bhatnagar S. Variable selection in regression-based estimation of dynamic treatment regimes. Biometrics. 2021 Nov 27. doi: 10.1111/biom.13608. Epub ahead of print. PMID: 34837380.
Moodie EEM, Coulombe J, Danieli C, Renoux C, Shortreed SM. Privacy-preserving estimation of an optimal individualized treatment rule: a case study in maximizing time to severe depression-related outcomes. Lifetime Data Anal. 2022 Jul;28(3):512-542. doi: 10.1007/s10985-022-09554-8. Epub 2022 May 2. PMID: 35499604.

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

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

Automated Virtual Follow-Up to Reduce Premature Treatment Discontinuation

Project Name:
Automated Virtual Follow-Up to Reduce Premature Treatment Discontinuation

Grant Number:
U19MH092201 (Pilot study under MHRN II)

Principal Investigator:
Robert Penfold, PhD

Principal Investigator Contact Information:
robert.b.penfold@kp.org

Funder
NIMH

Funding Period:
07/2017 – 06/2019

Abstract:
Recent developments in health informatics have created the potential for more efficient and more targeted outreach programs to address dropout from depression treatment. First, electronic medical records databases allow real-time evaluation of patients who are “overdue” for prescription refills and follow-up visits. Second, increasing use of standardized depression severity measures (such as the PHQ9), allow efficient identification of those at risk for unfavorable outcomes. Third, increasing use of patient-provider online messaging will permit much more efficient outreach communication. We are conducting a pilot study of a semi- automated outreach program for adult outpatients who appear to have dropped out of acute-phase depression treatment (either pharmacotherapy or psychotherapy). Participants with missed antidepressant refills or missed psychotherapy sessions are emailed a short questionnaire to ask about their intentions for treatment as well as a PHQ9, GAD2, and AUDIT-C. Feedback on patients’ answers is delivered immediately in a web-based format.

Participating Sites:
Kaiser Permanente Washington (Lead Site)
Kaiser Permanente Colorado

Investigators:
Robert Penfold, PhD
Arne Beck, PhD

Major Goals:
Conduct a pilot study of a completely automated outreach program for adult outpatients who appear to have dropped out of acute-phase depression treatment (either pharmacotherapy or psychotherapy).

Description of study sample:
The study population will include up to 2400 adult patients in participating health systems who initiate medication or psychotherapy treatment for depression.

Current Status:
Health record data were used to identify KP adult members eligible for outreach with a new depression diagnosis who have started therapy and appear to have discontinued prematurely, but do not have a recorded good outcome (most recent PHQ9 on record total score is >=10). A secure outreach message, including a link to an externally hosted questionnaire in Research Electronic Data Capture (REDCap) was sent to identified subjects through kp.org (i.e., MyChart). The study questionnaire was comprised of (2) standard assessments used for depression and suicide risk screening and a number of treatment- specific questions.PHQ9- standard assessment measuring depression severityCSSR-S- standard assessment measuring severity of suicidal ideation/ behavior. Depression Treatment Discontinuation QuestionsSubjects who returned the questionnaire were provided tailored feedback, ranging from “glad to hear that you are planning to continue care” to “we’d like to see you feeling better/we want to make sure that you are receiving the care you need- please consider scheduling an appt.” The web-based consent process and survey were hosted on KPCO’s internal instance of Research Electronic Data Capture (REDCap)All patient recruitment and outreach activities are complete. Data collection is complete. During the recruitment phase we identified and enrolled 988 subjects meeting study criteria for initiating psychotherapy. After ongoing monitoring of enrolled subjects, 657 subjects were flagged as potentially discontinuing psychotherapy treatment early. Subjects flagged by the automated algorithm as potential ‘early discontinuers’ were manually reviewed for meeting ‘discontinuation of treatment’ study criteria. After manual review, 518 qualified subjects were outreached through the electronic health record with an invitation to complete the depression treatment questionnaire. 70 of the 518 qualified subjects who were sent an invitation to complete the depression treatment questionnaire- responded.63 fully completed AND 7 people who consented but did not fully complete all components of the questionnaire.

Study Registration:
N/A – study hasn’t started yet

Publications:
N/A

Resources:
N/A

Lessons Learned:
N/A

What’s next?
N/A

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 Psychology. In 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.