Dialectical Behavior Therapy for Pregnant Women

NCT03938350 | Completed

• 1 other identifier: IRB00111022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Depression

Keywords

Toxic stress; Maternal PTSD; Mindfulness-based intervention; Dialectical Behavior Therapy; Transgenerational transference of health disparities; Virtual intervention

Outcome Measures

Primary Outcomes (2)

• Recruitment Rate

  Feasibility of the intervention will be assessed by the number of women who agree to participate in the study, among those who are approached about participation.

  Baseline

• Retention Rate

  Feasibility of the intervention will be assessed by the number of participants completing the 8 week intervention.

  Week 8

Secondary Outcomes (5)

• Acceptability of the Intervention

  Week 8

• Change in Patient Health Questionnaire (PHQ-9) Score

  Baseline, Week 8

• Change in PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) Score

  Baseline, Week 8

• Change in Difficulties in Emotion Regulation Scale (DERS) Score

  Baseline, Week 8

• Change in The Reflective Functioning Questionnaire (RFQ-8) Score

  Baseline, Week 8

Study Arms (2)

Dialectical Behavior Therapy (DBT) Skills Training

EXPERIMENTAL

Participants in this group will receive 8 weeks of Dialectical Behavior Therapy (DBT) Skills Training.

Behavioral: Dialectical Behavior Therapy (DBT) Skills Training

Treatment as Usual

NO INTERVENTION

Participants in this study arm will receive treatment as usual consisting of routine prenatal care with any mental health assessment, social work involvement or mental health service provision based on clinician referral or self-referral.

Interventions

Dialectical Behavior Therapy (DBT) Skills Training BEHAVIORAL

Standard DBT skills training is a comprehensive intervention for emotion dysregulation that includes four skills modules: (1) mindfulness skills; (2) emotion regulation skills; (3) interpersonal effectiveness skills; and (4) distress tolerance skills designed to target adaptive skills deficits that define emotion dysregulation. The sessions will be delivered virtually via a HIPAA-compliant video platform.

Dialectical Behavior Therapy (DBT) Skills Training

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Presence of intellectual disability or actively displaying psychotic symptoms

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Related Publications (1)

• Jones KA, Freijah I, Brennan SE, McKenzie JE, Bright TM, Fiolet R, Kamitsis I, Reid C, Davis E, Andrews S, Muzik M, Segal L, Herrman H, Chamberlain C. Interventions from pregnancy to two years after birth for parents experiencing complex post-traumatic stress disorder and/or with childhood experience of maltreatment. Cochrane Database Syst Rev. 2023 May 4;5(5):CD014874. doi: 10.1002/14651858.CD014874.pub2.

  PMID: 37146219 DERIVED

MeSH Terms

Interventions

Dialectical Behavior Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Abigail Lott, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

• Briana Woods-Jaeger, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 6, 2019
• Study Start: October 16, 2019
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)