Preventing Depressive Relapse in Pregnant Women With Recurrent Depression
Preventing Depressive Relapse in Pregnant Women With Recurrent Depression
The purpose of this investigation is to conduct a pragmatic effectiveness trial comparing
 digital mindfulness-based cognitive therapy (MBCT) plus usual care to usual care (UC) only
 among euthymic pregnant women with recurrent depression treated with antidepressants.

 In the supplemental arms we will investigate the prevalence, severity, longitudinal course,
 correlates, and predictors of suicidal ideation and behavior among women during pregnancy and
 the postpartum period.
This study will address a significant gap in the evidence regarding effective approaches to
 prevent depressive relapse among women with recurrent depression who maintain euthymia using
 antidepressants and who wish to conceive or who are pregnant. Relapse rates of depression
 following antidepressant discontinuation among such women has been established, and the
 efficacy of MBCT in mitigating relapse risk in pregnant women with recurrent depression
 compared to UC also has been demonstrated. But the effectiveness of MBCT has not been tested
 in a definitive trial; the question of whether MBCT can mitigate risk for depressive relapse
 among pregnant women on antidepressants, including among those who discontinue
 antidepressants proximate to or during pregnancy, also has not been addressed.

 Reproductive age women with recurrent depression and their healthcare providers need to know,
 first, if a scalable digital non-pharmacologic prevention approach is superior to UC in
 community settings, and second, whether MBCT can attenuate risk for depressive relapse among
 those who elect to discontinue maintenance antidepressant treatment proximate to or during
 pregnancy. Lastly, the capacity to identify which women are most likely to benefit from a
 non-pharmacologic or pharmacologic approach personalizes the risk benefit decision making
 process for reproductive age women on antidepressants planning to conceive or who are
 pregnant.

 Investigators will test the relative risk for depressive relapse and reduction of symptom
 burden between women randomized to digital MBCT or UC, explore the specific benefit of MBCT
 relative to antidepressant discontinuation, and determine whether a treatment selection
 algorithm can predict whether MBCT or UC will work best for a specific participant.

 The supplemental arms of this study will further investigate suicidal ideation and behavior
 in a perinatal population to better understand the prevalence, severity, longitudinal course,
 correlates and predictors of suicidal ideation and behavior among women during pregnancy and
 in the postpartum period.

 Investigators will use a mixed methods approach of both cross-sectional and longitudinal
 study designs to characterize a real-world population of pregnant and postpartum women who
 have endorsed suicidality. Investigators will also use qualitative interviews, self-report
 instruments, and medical records to explore the extent to which community healthcare
 professionals providing care to perinatal women report the knowledge base and requisite
 skills to address suicidal ideation and behavior in this population.

 MMB for Moms delivers digitally both the content and structure of in-person MBCT, and may be
 a promising intervention for pregnant women with suicidal ideation. Investigators will also
 explore the safety, feasibility, and acceptability of enrolling pregnant women with any
 reports of suicidal ideation or behavior in a proof of concept randomized controlled trial
 comparing MMB for Moms to enhanced usual care.
Inclusion Criteria:

 -  Pregnant women

 -  Ages 18 or older

 -  History of recurrent major depression prior to pregnancy (at least 2 prior episodes,
 one of which may be currently treated)

 -  Euthymic or with residual symptoms (PHQ-9 ≤ 9)

 -  No depressive relapse since last menstrual period

 -  Currently or recently received antidepressants (within the three months prior to last
 menstrual period)

 -  Presence of ongoing community provider

 Exclusion Criteria:

 -  Diagnosis of bipolar or psychotic disorder

 -  Active mania, psychosis, or substance abuse (within the last 6 months)

 -  Immediate risk of self-harm

 -  Non-English speaking

 Inclusion and exclusion criteria for the participants in the supplemental arms of the study
 differ from the main study and are as follows:

 Arm 1 Aim 1a

 Inclusion Criteria:

 -  Pregnant women (prior to 16 weeks gestation)

 -  Age 18 or older

 -  Presence of an ongoing community prescriber / provider

 -  Suicidal ideation as noted by item #9 of the PHQ-9

 -  History of recurrent depression, dysthymia or subsyndromal depression

 Exclusion Criteria:

 -  Diagnosis of bipolar or psychotic disorder

 -  Mania, psychosis, or active substance abuse (within the last 6 months for substance
 abuse)

 -  Non-English speaking

 Arm 1 Aim 1b

 Inclusion Criteria:

 -  Age 18 or older

 -  Current prenatal healthcare provider of a participant enrolled in Arm 1 Aim 1a

 Exclusion Criteria:

 -  Non-English speaking

 Arm 1 Aim 1c

 Inclusion Criteria:

 -  Pregnant women

 -  Age 18 or older

 -  Self-reported history of major depressive disorder

 -  Suicidal ideation as noted by item #9 of the PHQ-9

 Exclusion Criteria:

 -  Non-English speaking

 Arm 2

 Inclusion Criteria:

 -  Pregnant women (prior to 16 weeks gestation)

 -  Age 18 or older

 -  History of recurrent major depression prior to pregnancy (at least two prior episodes,
 one of which may be currently treated)

 -  Euthymic or with residual symptoms (PHQ-9 </=9)

 -  Presence of an ongoing community prescriber / provider

 -  Current suicidal ideation as noted by item #9 of the PHQ-9 or past suicidal ideation
 as noted by item A3g on the MINI mood module

 Exclusion Criteria:

 -  Diagnosis of bipolar or psychotic disorder

 -  Mania, psychosis, or active substance abuse (within the last 6 months for substance
 abuse)

 -  Non-English speaking