Sona Dimidjian - US grants

[unreadable] DESCRIPTION (provided by applicant): 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 [unreadable] [unreadable] [unreadable]

DESCRIPTION (provided by applicant): This is a Phase II Small Business Innovation Research (SBIR) grant application to support the further development of an innovative, online training program to aid in the dissemination of Behavioral Activation (BA), a therapy for depression. The current application represents a continued cooperative partnership between the small business, Behavioral Tech Research, Inc., a company dedicated to disseminating effective psychosocial treatments and Dr. Sona Dimidjian, who with colleagues, developed and evaluated the efficacy of BA. BA is an evidence-based treatment for Major Depressive Disorder, which may have particular transportability advantages compared to other psychosocial treatments with the similar aims. The proposed online training program will substantially aid in the vital training and utilization of this evidence-based practice for both community clinicians and clinical students. The course will be based on our successful Phase I program which was rated highly for usability and content. We plan to substantially expand the content of the training to include all remaining content from the primary BA treatment manual. We will expand the program's interactivities to include highly interactive performance-based learning activities that immerse the user within the treatment context. Ultimately, the aims of this Phase II proposal are to;1) Determine content for the final program utilizing an advisory board of BA experts;2) Create the program using an iterative process of development and evaluation;and, 3) Conduct a between-subjects randomized, controlled hybrid efficacy/effectiveness trial (N=240) using an additive research design to evaluate gains in knowledge and application of BA and gains in self-efficacy for conducting BA therapy with patients suffering from major depression. PUBLIC HEALTH RELEVANCE: Major depression is a pervasive and debilitating disorder, for which the majority of individuals receive no or inadequate treatment, despite the fact that efficacious treatments exist. Increasing the availability of such treatments requires widely available and effective training materials that will facilitate the utilization of such approaches by practicing clinicians. Behavioral Activation (BA) is an evidence-based practice for depression that may have important transportability advantages;this project aims to further develop an innovative, interactive online training program teaching the principles of BA, in order to increase the dissemination of this evidence-based treatment and improve clinical outcomes for adults suffering from depression.

PROJECT SUMMARY Depression is a prevalent problem during pregnancy,1,2 with adverse and potentially enduring correlates and consequences for mothers and infants;3 however, there is a persistent failure to provide intervention for the majority of depressed pregnant women,4 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.5 Pregnant women prefer care that is non-pharmacological6,7 and that is integrated within the obstetric setting,8 and they consult informal sources more than professional ones regarding mental health.9 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.10 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.11-18 Behavioral Activation (BA)19-21 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,15 and may engage social putative targets of depression care that are relevant to depression among women.22 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.23 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).

PROJECT SUMMARY Depression is a prevalent problem during pregnancy,1,2 with adverse and potentially enduring correlates and consequences for mothers and infants;3 however, there is a persistent failure to provide intervention for the majority of depressed pregnant women,4 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.5 Pregnant women prefer care that is non-pharmacological6,7 and that is integrated within the obstetric setting,8 and they consult informal sources more than professional ones regarding mental health.9 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.10 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.11-18 Behavioral Activation (BA)19-21 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,15 and may engage social putative targets of depression care that are relevant to depression among women.22 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.23 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).

PROJECT ABSTRACT Depressive relapse during pregnancy is highly prevalent particularly among women with recurrent depression. Maternal psychiatric morbidity associated with depressive relapse during pregnancy is of concern as is the impact of untreated mood disorder during pregnancy and the postpartum period on child development. While maintenance antidepressant treatment is the standard of care for women with recurrent depression, concerns exist regarding known and unknown effects of fetal exposure to these agents; understandably, many pregnant women and their providers seek non-pharmacologic alternatives to pharmacologic treatment during pregnancy. Mindfulness-based cognitive therapy (MBCT) is efficacious in the prevention of depressive relapse among pregnant women as compared to usual care and is scalable using digital delivery. We propose a pragmatic effectiveness trial comparing MBCT to usual care (UC) among euthymic pregnant women (N=500) with recurrent depression treated with maintenance antidepressants. The study will be conducted at the University of Colorado Boulder (UCB; PI Dimidjian) and Massachusetts General Hospital (MGH; PI Cohen) using the Collaborative RO1 mechanism. This grant mechanism is justified given the unique expertise brought by each site to the proposed investigation. Specifically, the UCB site provides expertise in pragmatic randomized trials and MBCT for pregnant women, and the MGH site provides expertise in prospective monitoring of pregnant women with mood disorders. We will address three primary aims: 1) to examine the relative risk for depressive relapse and reduction of symptom burden between women randomized to digital MBCT or UC; 2) to examine the risk for depressive relapse between women who are randomized to MBCT who discontinue antidepressant treatment and those randomized to UC who discontinue antidepressant treatment, and to apply a treatment selection algorithm to ask what works for whom with respect to MBCT versus antidepressant maintenance; and 3) to examine the extent to which digital MBCT engages key putative targets. Systematic investigation of interventions that can attenuate risk for depressive relapse during pregnancy particularly in ?at risk? populations minimizes the morbidity of recurrent depression during critical times in the lives of reproductive aged women.

Project Summary/Abstract The last decade has brought increased attention to the significance of early identification and prevention of perinatal depression leading to the USPTF guidelines for care of this population. To that end, we were funded in the current collaborative R01 mechanism R01MH117251 to study the effectiveness of MMB for Moms for euthymic women with recurrent depression treated with maintenance antidepressants (N=500) across pregnancy and the postpartum period, entitled the Understanding and Preventing Women?s Relapse of Depression (UPWARD). In this pragmatic effectiveness trial, comparing MMB for Moms to enhanced Usual Care (UC), we have documented that large numbers of women report suicidal ideation at the time of initial screening as measured by PHQ-9. Specifically, among the pregnant women we excluded during the first three months of screening (n = 6,525), over 1,800 women (n = 1,827; 28%) were excluded due to endorsement of suicidal ideation, which notably exceeds the upper limit of estimates of suicidal ideation and behavior among pregnant women based on prior work. The administrative supplement in response to Notice NOT-MH-19-026, Administrative Supplements for NIMH Grants to Expand Suicide Research, is proposed to support work at each of the two sites, the University of Colorado Boulder (UCB; PI Dimidjian) and Massachusetts General Hospital (MGH; PI Cohen). This grant mechanism is justified given the unique expertise brought by each site to the proposed investigation. Specifically, the UCB site provides expertise in pragmatic randomized trials and MBCT for pregnant women as well as qualitative methods, and the MGH site provides expertise in prospective monitoring of pregnant women with mood disorders and implementation of the risk assessment and response protocol. We will address three specific aims with a total sample of pregnant women (N = 630) and prenatal healthcare providers (N = 100): 1) to characterize suicidal ideation and behavior among pregnant and postpartum women using both cross-sectional and longitudinal designs; 2) to use qualitative interviews with prenatal healthcare providers to describe the extent to which community healthcare providers report the knowledge base and requisite skills to address suicidal ideation; 3) to use expanded entry criteria to include women reporting suicidal ideation in a trial of MMB for Moms.