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Perinatal DepressionNCT03938350

Dialectical Behavior Therapy for Pregnant Women

A study testing Dialectical Behavior Therapy (DBT) Skills Training in people with Perinatal Depression, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Perinatal Depression
What is being tested?
Dialectical Behavior Therapy (DBT) Skills Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
16 Oct 2019to 9 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Presence of intellectual disability or actively displaying psychotic symptoms

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Grady Health System

    Atlanta, Georgia, 30303

Other trials in United States

About this study

Official title: Dialectical Behavior Therapy Skills Training for High-Risk African American Pregnant Women: Feasibility and Acceptability of Implementation in Prenatal Clinics

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.

Read the 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.

Being tested
Dialectical Behavior Therapy (DBT) Skills Training
Keywords
Toxic stress, Maternal PTSD, Mindfulness-based intervention, Dialectical Behavior Therapy, Transgenerational transference of health disparities, Virtual intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dialectical Behavior Therapy (DBT) Skills TrainingBehavioural

    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.

Study groups in NCT03938350
Study groupRoleWhat they receive
Dialectical Behavior Therapy (DBT) Skills TrainingExperimentalParticipants in this group will receive 8 weeks of Dialectical Behavior Therapy (DBT) Skills Training.
Receives: Behavioral: Dialectical Behavior Therapy (DBT) Skills Training
Treatment as UsualNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. Retention Rate

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

    Measured: Week 8

Secondary outcomes (5)
  1. Acceptability of the Intervention

    Acceptability of the intervention will be assessed through qualitative participant feedback. We will use a 25-item semi-structured interview to explore participants': (1) attitudes and beliefs related to the content of the intervention; (2) experiences with intervention components (e.g., facilitators' teaching skill, group interactions, and intervention exercises like role play/practices); and (3) barriers and facilitators for implementing the skills learned in the intervention in their daily life. Responses are in text form rather than on a pre-set scale.

    Measured: Week 8

  2. Change in Patient Health Questionnaire (PHQ-9) Score

    The PHQ-9 is a 9-item self-report questionnaire developed to identify patients at risk for depression. Participants report how often they have been bothered by specific symptoms of depression on a scale of 0 (not at all) to 3 (nearly every day). Higher scores indicate greater symptoms of depression. A score of ≥ 9 indicates clinically significant symptoms.

    Measured: Baseline, Week 8

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

    The PCL-5 instrument is a 20-item self-report measure that assesses DSM-5 symptoms of PTSD. Participants report how often they have been bothered by specific symptoms of PTSD on a scale of 0 (not at all) to 4 (extremely). The total symptom severity score ranges from 0 to 80. A provisional PTSD diagnosis can be made and a PCL-5 cut-point score of 33 is recommended.

    Measured: Baseline, Week 8

  4. Change in Difficulties in Emotion Regulation Scale (DERS) Score

    The DERS is a 36-item self-report measure that assesses 6 facets of emotion dysregulation. Participants report how much of the time they feel specific ways on a scale of 1 (almost never) to 5 (almost always). Totals scores range from 36 to 180 and higher scores indicate greater difficulties with emotion regulation.

    Measured: Baseline, Week 8

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

    The RFQ-8 is an 8-item self-report screener that assesses mentalizing or reflective functioning (understanding intentional mental states such as feelings, desires, and attitudes). Responses are given on a 7-point scale where 1 = strongly disagree and 7 = strongly agree (scoring is reversed for one item). Total raw scores range from 8 to 56 where higher scores indicate poorer reflective functioning.

    Measured: Baseline, Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2019
  2. Study start16 Oct 2019
  3. Primary completion9 Sep 2022
  4. Study completion9 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03938350
Sponsor's protocol ID
IRB00111022
Status last verified
Sep 2022
First submitted
2 May 2019
Last updated
30 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37146219

Questions about this trial

What is this clinical trial studying?

A study testing Dialectical Behavior Therapy (DBT) Skills Training in people with Perinatal Depression, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03938350, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022; AzTrials last refreshed its copy on 3 Nov 2026.

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