Preventing Depressive Relapse in Pregnant Women With Recurrent Depression
Completed · Not applicable
Conditions studied: Depression, Pregnancy Related, Antenatal Depression
In brief
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.
Key facts
- Study ID
- NCT03623620
- Run by
- Massachusetts General Hospital
- People needed
- 500
- Starts
- 2019-03-12
- Expected to finish
- 2022-03-21
- Last updated by the study team
- 2023-06-06
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Colorado Boulder — Boulder, Colorado, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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