Status:

TERMINATED

Mindfulness Based Cognitive Therapy (MBCT) During Pregnancy

Lead Sponsor:

Oregon Health and Science University

Conditions:

Maternal Psychological Distress

Postpartum Depression

Eligibility:

FEMALE

21-45 years

Phase:

NA

Brief Summary

The study is a pilot randomized control trial of a validated intervention, Mindfulness Based Cognitive Therapy (MBCT) adapted for pregnancy, developed to reduce risk for postpartum depression. This st...

Detailed Description

The study will involve an online screen of potentially eligible pregnant women. If participants are eligible after the online screen, they will be invited in for an in person assessment, including cog...

Eligibility Criteria

Inclusion

  • Inclusion:
  • female who is currently pregnant (8-22 weeks gestational age (GA) at time of screen)
  • 21-45 years old
  • single gestation
  • fluently speak English
  • be available and physically able to attend scheduled group meetings
  • have a prior history of at least 1 major depressive episode (as determined through psychiatric interviewing).
  • Exclusion (at enrollment):
  • Magnetic Resonance Imaging (MRI) contraindication (e.g., metal in their body)
  • major neurological or medical illness (e.g., diabetes, multiple sclerosis)
  • history of head trauma (loss of conscious \> 2 minutes)
  • Intelligence Quotient (IQ) \< 80
  • uncorrectable vision or hearing impairments (including color blindness)
  • use of psychotropic medications, corticosteroids, insulin, or any other medications that might impact the central nervous system
  • current illicit drug use or diagnosis of a current substance use disorder
  • current diagnosis of an eating disorder
  • current depressive or manic episode
  • diagnosis of a neurodevelopmental disorder (Autism, Intellectual Disability)
  • any history of psychosis
  • current active suicidality and/or homicidality, or interpersonal violence
  • prior history of engaging in mindfulness-based psychotherapeutic interventions (e.g., Mindfulness Based Cognitive Therapy (MBCT), Mindfulness Based Stress Reduction (MBSR), Dialectical Behavior Therapy (DBT))
  • known congenital, genetic, or neurologic disorder of the fetus (e.g., Down syndrome, fragile X)
  • pregnancy-specific medical conditions or complications that significantly increase risk (e.g., placental separation, placenta previa)
  • History of meningitis or seizures (except infantile or febrile)

Exclusion

    Key Trial Info

    Start Date :

    March 22 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 8 2021

    Estimated Enrollment :

    56 Patients enrolled

    Trial Details

    Trial ID

    NCT03809572

    Start Date

    March 22 2019

    End Date

    March 8 2021

    Last Update

    December 20 2021

    Active Locations (1)

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    Oregon Health and Science University

    Portland, Oregon, United States, 97239