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

Trial Summary

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 data supports the effectiveness of the treatment DBT-P for emotional dysregulation?

Research shows that dialectical behavior therapy (DBT) can help improve emotional regulation and reduce symptoms in people with borderline personality disorder, which often includes emotional dysregulation. Studies on DBT skills groups have also shown improvements in anxiety, depression, and quality of life, suggesting that DBT-P might be effective for emotional dysregulation. ^{1 2 3 4 5}

Is DBT-P safe for humans?

Botulinum toxin type A (BTX-A), which may be related to DBT-P, is generally considered safe for humans. Studies show it is well-tolerated with only mild and temporary side effects reported, even with long-term use in various conditions. ^{6 7 8 9 10}

How does the treatment DBT-P differ from other treatments for emotional dysregulation?

DBT-P (Dialectical Behavior Therapy for Parenting) is unique because it focuses on improving emotion regulation skills, which are crucial for effective parenting, and targets emotional dysregulation, a common issue across various mental health conditions. Unlike other treatments, DBT-P emphasizes teaching specific skills to manage emotions, which can help prevent psychopathology in children by enhancing parenting quality. ^{1 11 12 13 14}

What is the purpose of this trial?

The goal of this study is to find out if improving emotion regulation skills use during pregnancy reduces maternal stress and improves heart rate. The main questions it aims to answer are: * Does improving emotion regulation skills during pregnancy reduce stress and improve the ability to cope? * How is a participant's heart rate affected by their ability to control their emotions during pregnancy? Researchers will test the hypothesis that dialectical behavior therapy skills groups (DBT-P) will improve emotion regulation skills use as well as heart rate. Participants will: * Visit the clinic for 3 sessions at the beginning, middle and end of their pregnancy. * Compete surveys and interviews asking about their thoughts, feelings and how they cope with emotions. * Have their heart rate taken. * If assigned to the investigational group, they will complete weekly remote emotion regulation skills groups for 10 weeks and complete daily diary cards that ask about mood and any thoughts of self-harm.

Research Team

Elisabeth Conradt, PhD

Principal Investigator

Duke University

Andrada Neacsiu, PhD

Principal Investigator

Duke University

Sheila Crowell, PhD

Principal Investigator

University of Oregon

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The effectiveness of a short-term DBT skills group in a 'real-world' clinical setting. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a 5-Week Inpatient Dialectical Behavior Therapy for Borderline Personality Disorder. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A Dialectical Behavior Therapy Skills Group in a Psychoanalytic Community Service: A Pilot Study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of brief dialectical behaviour therapy skills training in suicidal patients suffering from borderline disorder. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

[New insights into diagnostics and therapy of personality disorders-Changes in ICD-11]. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Botulinum Toxin vs. Placebo in Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Safety of botulinum toxin type A: a systematic review and meta-analysis. [2018]

8. England pubmed.ncbi.nlm.nih.gov

A review of AbobotulinumtoxinA (Dysport). [2016]

9. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of botulinum toxin type A following long-term use. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Adverse drug reactions of botulinum neurotoxin type A in children with cerebral palsy: a pharmaco-epidemiological study in VigiBase. [2017]

11. England pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy skills use and emotion dysregulation in personality disorders and psychopathy: a community self-report study. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Dialectical Behavior Therapy in Emotion Dysregulation - Report of Two Cases. [2020]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Identifying novel applications of dialectical behavior therapy: considering emotion regulation and parenting. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Emotion dysregulation, symptoms, and interpersonal problems as independent predictors of a broad range of personality disorders in an outpatient sample. [2018]