DBT-P for Emotional Dysregulation

(REACH Trial)

Overseen By Janea Cato

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Active psychosis, Drug/alcohol use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 10 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if learning emotion regulation skills during pregnancy can reduce stress and improve heart rate. It compares two groups: one will attend weekly sessions to learn skills like self-awareness and emotion management through Dialectical Behavior Therapy for Pregnancy (DBT-P), while the other follows a standard support program. The study seeks pregnant individuals who are at least 12 weeks along and often feel overwhelmed by their emotions. Participants will engage in surveys, interviews, and heart rate monitoring. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could enhance emotional well-being during pregnancy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that DBT-P is safe for pregnant individuals?

Studies have shown that Dialectical Behavior Therapy (DBT) can help people better manage their emotions. This is particularly important for expecting mothers who may experience stress during pregnancy. Research indicates that DBT is generally safe, with most individuals not experiencing serious side effects.

In one study, researchers used DBT with a pregnant woman who had COVID-19, finding it helpful without causing major issues. Another review suggested that DBT could improve mental health during pregnancy, although further research is needed to confirm this.

Overall, DBT appears to be a safe way to manage stress and emotions during pregnancy. However, as with any treatment, discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

DBT-P is unique because it adapts Dialectical Behavior Therapy (DBT) specifically for pregnant individuals experiencing emotional dysregulation. Unlike standard treatments that may focus more broadly on mental health without tailoring to the unique challenges of pregnancy, DBT-P enhances self-awareness, crisis management, and emotional regulation while also improving relationships and self-respect. Researchers are excited about DBT-P because it combines these skills in a structured group setting, offering both emotional support and practical strategies to manage stress during pregnancy. This targeted approach could provide more immediate and relevant coping mechanisms compared to more generalized mental health treatments.

What evidence suggests that DBT-P could be an effective treatment for emotional dysregulation during pregnancy?

Research has shown that Dialectical Behavior Therapy (DBT) can help individuals manage emotions and improve well-being during challenging times, such as after traumatic childbirth. Studies have found DBT promising for treating mental health issues during and after pregnancy by enhancing emotional control. In this trial, participants in the DBT-P arm, a version of DBT tailored for pregnant individuals, will attend weekly group sessions to learn skills like self-awareness and crisis management. This approach might help reduce stress and improve heart rate. Meanwhile, participants in the Moms2B arm will receive sessions focused on enhancing social support and improving nutrition. ^{2 4 5 6 7}

Who Is on the Research Team?

Elisabeth Conradt, PhD

Principal Investigator

Duke University

Andrada Neacsiu, PhD

Principal Investigator

Duke University

Sheila Crowell, PhD

Principal Investigator

University of Oregon

Are You a Good Fit for This Trial?

This trial is for pregnant individuals experiencing emotional dysregulation. They must be able to attend three clinic sessions and complete surveys, interviews, and heart rate measurements. Participants in the investigational group will also engage in weekly remote emotion regulation skills groups for 10 weeks and fill out daily diary cards.

Inclusion Criteria

Emotion dysregulation score of 88 or above

Singleton Pregnancy

Fluent in English

Exclusion Criteria

Drug or alcohol use disorder during pregnancy

Active psychosis

High risk of an imminent suicide attempt

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly DBT-P group sessions for 10 weeks, complete daily diary cards, and participate in surveys and interviews

10 weeks

3 in-person visits (beginning, middle, end of pregnancy), weekly remote sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of emotion regulation and heart rate

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DBT-P

Trial Overview

The study is testing whether dialectical behavior therapy (DBT-P) can help manage emotions during pregnancy, reduce stress, and improve heart rates. It compares outcomes between those receiving DBT-P intervention and a control group over the course of their pregnancy.

How Is the Trial Designed?

Group I: DBT-P Experimental Treatment 2 Interventions

DBT-P is a Dialectical Behavior Therapy skills group adapted for pregnant people. Participants will receive weekly DBT-P group sessions for 10 weeks where they learn skills to: (1) enhance self-awareness; (2) improve ability to manage crises; (3) decrease negative emotions and increase positive emotions; (4) improve your relationships and self-respect; they will also complete homework as part of the group participation as well as complete daily diary cards that will ask about their mood and any thoughts of self-harm . Completion of surveys and clinical interviews assessing stress, coping strategies and emotions are included; resting heart rate data as well as heart rate data post stimulus to be assessed.

Group II: Moms2B Active Control 1 Intervention

Moms2B is an established group-based intervention for pregnant women focused on enhancing social support and improving nutrition. Participants will receive 3 sessions using this established assessment only treatment plan as well as complete surveys and clinical interviews assessing stress, coping strategies and emotions. Resting heart rate data as well as heart rate data post stimulus to be assessed.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

University of Oregon

Collaborator

Trials

91

Recruited

46,700+

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Trials

275

Recruited

5,182,000+

Published Research Related to This Trial

A study involving 84 out-patients with borderline personality disorder (BPD) found that 20 weeks of brief dialectical behavior therapy (DBT) skills training significantly reduced suicidal and self-injurious behaviors compared to a waitlist group.

Participants receiving DBT also showed notable improvements in anger management, distress tolerance, and emotion regulation, suggesting that this brief intervention can effectively support high-risk behaviors in BPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of brief dialectical behaviour therapy skills training in suicidal patients suffering from borderline disorder. McMain, SF., Guimond, T., Barnhart, R., et al.[2022]

Dialectical behavior therapy (DBT) is effective for various mental disorders by specifically targeting emotion dysregulation, a common issue across many psychological conditions.

DBT's application has expanded to include improving parenting quality, which can help prevent psychopathology in children, highlighting its versatility and potential benefits beyond traditional diagnostic categories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying novel applications of dialectical behavior therapy: considering emotion regulation and parenting. Zalewski, M., Lewis, JK., Martin, CG.[2022]

A study analyzing 162 individual case safety reports of botulinum neurotoxin type A (BoNT-A) in children with cerebral palsy found a significant association between BoNT-A and adverse drug reactions (ADRs), particularly a higher risk of serious outcomes like death (ROR=11.1).

The most common ADRs reported were dysphagia, asthenia, and muscular weakness, indicating that the systemic spread of BoNT-A may contribute to these adverse effects, suggesting that children may experience a higher risk of ADRs compared to adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions of botulinum neurotoxin type A in children with cerebral palsy: a pharmaco-epidemiological study in VigiBase. Montastruc, J., Marque, P., Moulis, F., et al.[2017]

A meta-analysis of 36 randomized controlled trials involving 2309 subjects found that botulinum toxin type A (BOTOX) has a favorable safety profile, with no severe adverse events reported.

While mild to moderate adverse events occurred in about 25% of patients treated with BOTOX, focal weakness was the only side effect significantly more common than in the control group, indicating that BOTOX is generally well-tolerated across various therapeutic uses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of botulinum toxin type A: a systematic review and meta-analysis. Naumann, M., Jankovic, J.[2018]

AbobotulinumtoxinA, approved by the FDA in 2009 for facial aesthetics, is generally well tolerated and has a safety profile similar to other botulinum neurotoxin type A products.

The article discusses various clinical applications and indications for abobotulinumtoxinA, along with important information on handling, storage, and dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of AbobotulinumtoxinA (Dysport). Lorenc, ZP., Kenkel, JM., Fagien, S., et al.[2016]

Citations

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DBT-P for Emotional Dysregulation (REACH Trial)

Researchers will test the hypothesis that dialectical behavior therapy skills groups (DBT-P) will improve emotion regulation skills use as well as heart rate.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9533351/

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Applications of dialectical behavioural therapy in the ...

This review highlights that few studies have shown DBT-informed interventions to be effective in improving a range of perinatal mental health ...

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A similar review showed that DBT held promise in treating perinatal depression, but studies tended to be limited in that most only used some of ...

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Online Dialectical Behavioral Therapy for Emotion ...

Findings In this randomized clinical trial with 89 participants, those receiving iDBT-Pain demonstrated significant improvement in emotion ...

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DBT-P treatment study (Emotion Dysregulation During ...

We are doing this study to find out how well an emotion regulation skills training program can help expecting mothers lower stress during pregnancy and ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7110264/

Dialectical behavior therapy-based psychological ...

The present report demonstrated the use of DBT-based psychological intervention for a patient with COVID-19 during late pregnancy and early postpartum. The ...