Clinical trial NCT03938350: Dialectical Behavior Therapy for Pregnant Women
Official title: Dialectical Behavior Therapy Skills Training for High-Risk African American Pregnant Women: Feasibility and Acceptability of Implementation in Prenatal Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Depression
Keywords: Toxic stress
Maternal PTSD
Mindfulness-based intervention
Dialectical Behavior Therapy
Transgenerational transference of health disparities
Virtual intervention
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The cumulative effects of adverse childhood experiences (ACEs) can lead to prolonged activation of stress response systems, known as toxic stress. Toxic stress is increasingly recognized as an important contributor to socioeconomic and racial health disparities that emerge in early childhood and may persist across generations. African American women experience significant disparities in maternal and infant mortality, some of which may be attributable to toxic stress. The toxic stress response may increase risk factors for maternal and infant morbidity and mortality such as high-levels of stress hormones, high blood pressure, maternal PTSD and depression. Further, heightened maternal stress responses in pregnancy are associated with heightened infant stress responses, increasing the risk for the intergenerational transmission of toxic stress. Mindfulness-based interventions have demonstrated efficacy for a variety of mental health conditions, including depression and PTSD, are cost-effective, and scalable in diverse settings. Implementing mindfulness interventions for African American pregnant women with histories of ACEs and current depression and/or PTSD symptoms is novel and has the potential to interrupt the intergenerational cycle of toxic stress by improving maternal stress response and mental health. This study is a pilot, randomized controlled trial where participants will receive either Dialectical Behavior Therapy (DBT) Skills Training for 8 weeks (delivered virtually) or treatment as usual.

Detailed description: The cumulative effects of adverse childhood experiences (ACEs), including trauma exposure, parent mental health problems, family dysfunction, and experiences of racism can lead to prolonged activation of stress response systems, known as toxic stress. Toxic stress can adversely influence maternal and childhood health. Increased numbers of ACEs are associated with negative birth outcomes such as decreased birth weight and gestational age at delivery. An intergenerational transmission of toxic stress has been evidenced in disruptions to children's hypothalamic pituitary adrenal (HPA)-axis functioning that result in life long health impacts. African American women are at increased risk for ACEs and similarly experience disparities in birth outcomes including low-birth weight and preterm birth. Many low-income, urban African American women are navigating the demands of pregnancy while confronting compounding chronic stressors, such as dangerous neighborhoods, lack of adequate and accessible public services, poverty, and the historical context of injustice, discrimination, and disadvantage. Although early life adversity can have serious consequences lasting across the lifespan and generations, interventions during critical periods such as pregnancy have the potential to prevent the intergenerational transmission of toxic stress and associated health disparities.

Prenatal mindfulness-based interventions have been shown to reduce depression, anxiety, and stress in pregnant women. Mindfulness is recommended as a culturally relevant intervention to reduce stress-related health disparities among African American and has been found to be feasible and acceptable to African American women. Further, mindfulness-based interventions are efficacious for a variety of mental health conditions and are cost-effective and scalable in diverse settings. Dialectical Behavior Therapy (DBT) Skills Training is a group format mindfulness-based intervention with demonstrated efficacy for increasing emotional regulation abilities and reducing depression and PTSD symptoms. DBT Skills Training has been adapted for trauma-exposed populations and is considered a transdiagnostic intervention for emotion dysregulation. Further, it is increasing being used with parents who have trauma histories and/or mental health problems. Adapting DBT skills for pregnant women with a history of ACEs and current depression and/or PTSD symptoms is novel and has the potential to interrupt the intergenerational cycle of toxic stress by improving maternal stress response, depression, and PTSD, thus reducing the risk of the intergenerational transmission of toxic stress.

This study will examine initial feasibility, acceptability, and effectiveness of an adapted 8-week DBT Skills Training group for mothers-to-be (DBTMTB) for low-income, African American pregnant women with a history of ACEs and current depression and PTSD symptoms to be delivered virtually. This adapted DBT Skills Training to the context of pregnancy will include specific pregnancy and parenting applications of DBT mindfulness and emotion regulation skills and opportunities to practice applying mindfulness and emotion regulation skills to enhance management of chronic stressors. The researchers posit that DBTMTB addresses important contributors to persistent birth outcome health disparities experienced by African American women and has the potential to reduce the cycle of toxic stress and transgenerational transference of disparities in health by improving pregnant women's mental health and stress response.

Eligibility criteria: Inclusion Criteria:

* Self-identify as African American/Black (includes African American/Black and another race)
* Able to read, speak, and understand English
* Adverse Childhood Experiences (ACE) score ≥ 4 from the Expanded ACE Questionnaire
* PHQ-9 score ≥ 9 or PC-PTSD-5 ≥ 3
* Within first or second trimester at time of recruitment
* Willing and able to participate in research assessments
* Willing and able to participate in a 8-week DBT Skills Training group for mothers-to-be (DBTMTB) Group
* Willing and able to provide informed consent

Exclusion Criteria:

* Presence of intellectual disability or actively displaying psychotic symptoms

Primary outcomes:
measure: Recruitment Rate
timeFrame: Baseline
measure: Retention Rate
timeFrame: Week 8
Secondary outcomes:
measure: Acceptability of the Intervention
timeFrame: Week 8
measure: Change in Patient Health Questionnaire (PHQ-9) Score
timeFrame: Baseline, Week 8
measure: Change in PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) Score
timeFrame: Baseline, Week 8
measure: Change in Difficulties in Emotion Regulation Scale (DERS) Score
timeFrame: Baseline, Week 8
measure: Change in The Reflective Functioning Questionnaire (RFQ-8) Score
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
Study officials:
affiliation: Emory University
name: Abigail Lott, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Briana Woods-Jaeger, PhD
role: PRINCIPAL_INVESTIGATOR
References: