Perinatal mental health

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:

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 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.