Preventing Depressive Relapse in Pregnant Women With Recurrent Depression



Status:Enrolling by invitation
Conditions:Depression, Depression, Women's Studies
Therapuetic Areas:Psychiatry / Psychology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:3/17/2019
Start Date:March 12, 2019
End Date:June 1, 2022

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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.

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.

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
We found this trial at
2
sites
Boulder, Colorado 80309
(303) 492-1411
University of Colorado, Boulder As the flagship university of the state of Colorado, CU-Boulder is...
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Boulder, CO
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Lee S Cohen, MD
Phone: 617-724-6540
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Boston, MA
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