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Trial record 1 of 1 for:    NCT03623620
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Preventing Depressive Relapse in Pregnant Women With Recurrent Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03623620
Recruitment Status : Enrolling by invitation
First Posted : August 9, 2018
Last Update Posted : March 16, 2020
Sponsor:
Collaborators:
University of Colorado, Boulder
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Lee S. Cohen, MD, Massachusetts General Hospital

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.


Condition or disease Intervention/treatment Phase
Depression Pregnancy Related Antenatal Depression Behavioral: Digital Delivery of Mindfulness-Based Cognitive Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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).

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females
Accepts Healthy Volunteers:   No
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

Exclusion criteria:

  • Diagnosis of bipolar or psychotic disorder
  • Mania, psychosis, or active substance abuse (within the last 6 month 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 2 Inclusion Criteria

  • Pregnant women (prior to 16 weeks gestation)
  • Age 18 or older
  • History of recurrent major depression prior to pregnancy (at least 2 prior episodes, 1 of which may be currently treated)
  • Euthymic or with residual symptoms (PHQ-9 </=9)
  • Currently or recently receiving antidepressants (at most 12 weeks prior to LMP)
  • Presence of an ongoing community prescriber / provider
  • Suicidal ideation as noted by item #9 of the PHQ-9

Exclusion Criteria:

  • Diagnosis of bipolar or psychotic disorder
  • Mania, psychosis, or active substance abuse (within the last 6 month for substance abuse)
  • Non-English speaking

Information from the National Library of Medicine

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


Locations
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United States, Colorado
University of Colorado Boulder
Boulder, Colorado, United States, 80309
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
University of Colorado, Boulder
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Lee S Cohen, MD Massachusetts General Hospital
Principal Investigator: Sona Dimidjian, PhD University of Colorado, Boulder
Publications:
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Responsible Party: Lee S. Cohen, MD, Director, Center for Women's Mental Health, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03623620    
Other Study ID Numbers: 2018P001472
R01MH117253 ( U.S. NIH Grant/Contract )
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared via the National Database for Clinical Trials related to Mental Illness (NDCT) every 6 months after enrollment begins, and before publication. In addition, de-identified data and accompanying documentation describing and referencing all variables will be available for use by other investigators upon request.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data will become available 6 months after study start-up and will continue to be available throughout the study.
Access Criteria: Interested investigators will be asked to submit a proposal form, which will be reviewed by the principal investigator for scientific integrity and adherence to ethical guidelines.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lee S. Cohen, MD, Massachusetts General Hospital:
Depression
Pregnancy
Antidepressants
Mindfulness
Medication use during pregnancy
Depression Relapse
Suicidal ideation
Additional relevant MeSH terms:
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Recurrence
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Disease Attributes
Pathologic Processes