Clinical trial NCT03623620: Preventing Depressive Relapse in Pregnant Women With Recurrent Depression
Official title: Preventing Depressive Relapse in Pregnant Women With Recurrent Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Pregnancy Related
Antenatal Depression
Keywords: Depression
Pregnancy
Antidepressants
Mindfulness
Medication use during pregnancy
Depression Relapse
Suicidal ideation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Colorado, Boulder
name: National Institute of Mental Health (NIMH)
First posted: 2018-08-09
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Experiencing Relapse of Depression
timeFrame: Randomization through 6 months postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado Boulder
state: Colorado
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Lee S Cohen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Boulder
name: Sona Dimidjian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cohen LS, Altshuler LL, Harlow BL, Nonacs R, Newport DJ, Viguera AC, Suri R, Burt VK, Hendrick V, Reminick AM, Loughead A, Vitonis AF, Stowe ZN. Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment. JAMA. 2006 Feb 1;295(5):499-507. doi: 10.1001/jama.295.5.499.
citation: Dimidjian S, Goodman SH, Felder JN, Gallop R, Brown AP, Beck A. Staying well during pregnancy and the postpartum: A pilot randomized trial of mindfulness-based cognitive therapy for the prevention of depressive relapse/recurrence. J Consult Clin Psychol. 2016 Feb;84(2):134-45. doi: 10.1037/ccp0000068. Epub 2015 Dec 14.