100 Participants Needed

DBT-P for Emotional Dysregulation

(REACH Trial)

EC
AH
JC
Overseen ByJanea Cato
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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.111121314

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

EC

Elisabeth Conradt, PhD

Principal Investigator

Duke University

AN

Andrada Neacsiu, PhD

Principal Investigator

Duke University

SC

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
See 1 more

Exclusion Criteria

Drug or alcohol use disorder during pregnancy
Active psychosis
High risk of an imminent suicide attempt
See 2 more

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
2Treatment groups
Experimental Treatment
Active Control
Group I: DBT-PExperimental Treatment2 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: Moms2BActive Control1 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.

Find a Clinic Near You

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

References

The effectiveness of a short-term DBT skills group in a 'real-world' clinical setting. [2021]
Effectiveness of a 5-Week Inpatient Dialectical Behavior Therapy for Borderline Personality Disorder. [2021]
A Dialectical Behavior Therapy Skills Group in a Psychoanalytic Community Service: A Pilot Study. [2021]
A randomized trial of brief dialectical behaviour therapy skills training in suicidal patients suffering from borderline disorder. [2022]
[New insights into diagnostics and therapy of personality disorders-Changes in ICD-11]. [2020]
Efficacy and Safety of Botulinum Toxin vs. Placebo in Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2020]
Safety of botulinum toxin type A: a systematic review and meta-analysis. [2018]
A review of AbobotulinumtoxinA (Dysport). [2016]
Safety and efficacy of botulinum toxin type A following long-term use. [2022]
Adverse drug reactions of botulinum neurotoxin type A in children with cerebral palsy: a pharmaco-epidemiological study in VigiBase. [2017]
Dialectical behavior therapy skills use and emotion dysregulation in personality disorders and psychopathy: a community self-report study. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Dialectical Behavior Therapy in Emotion Dysregulation - Report of Two Cases. [2020]
Identifying novel applications of dialectical behavior therapy: considering emotion regulation and parenting. [2022]
Emotion dysregulation, symptoms, and interpersonal problems as independent predictors of a broad range of personality disorders in an outpatient sample. [2018]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity