Preventing Depressive Relapse in Pregnant Women With Recurrent Depression
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|ClinicalTrials.gov Identifier: NCT03623620|
Recruitment Status : Enrolling by invitation
First Posted : August 9, 2018
Last Update Posted : March 16, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression Pregnancy Related Antenatal Depression||Behavioral: Digital Delivery of Mindfulness-Based Cognitive Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1330 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Preventing Depressive Relapse in Pregnant Women With Recurrent Depression|
|Actual Study Start Date :||March 12, 2019|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||September 1, 2022|
Experimental: Digital delivery of MBCT (Mindful Mood Balance for Moms)
Subjects will receive digital delivery of mindfulness-based cognitive therapy (Mindful Mood Balance for Moms) for 12 weeks, along with the usual care they would receive from their provider.
Behavioral: Digital Delivery of Mindfulness-Based Cognitive Therapy
12-week program that emphasizes mindfulness and cognitive behavioral skills
No Intervention: Usual Care
Subjects will receive only usual care, the care they would normally receive from their community provider, for 12 weeks.
- Time to relapse [ Time Frame: Enrollment to 6 months postpartum ]Time to relapse will be determined through diagnosis of a major depressive episode using the mood module of the Mini-International Neuropsychiatric Interview (MINI).
- Depressive symptom burden [ Time Frame: Enrollment to 6 months postpartum ]Depressive symptom burden will be determined through scores on the Patient Health Questionnaire (PHQ-9) administered as part of the monthly self-report questionnaires
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623620
|United States, Colorado|
|University of Colorado Boulder|
|Boulder, Colorado, United States, 80309|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Lee S Cohen, MD||Massachusetts General Hospital|
|Principal Investigator:||Sona Dimidjian, PhD||University of Colorado, Boulder|