DBT-P Treatment Study
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Moms2B, DBT-P.
- Кому может быть актуально
- Состояния в реестре: Emotion Dysregulation. Базовые параметры: 18 лет — 45 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Developing Pregnancy-specific Dialectical Behavior Therapy Skills to Promote Multigenerational Mental Health
Обзор
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. * Optional Element: Complete a 20-30min infant neurobehavior exam (NNNS exam) after delivery.
Подробное описание
The investigators' observational research with mothers with emotion dysregulation and their infants shows that poor emotion regulation skill use is a mechanism that likely confers risk for self-injurious thoughts and behaviors, depression, and anxiety in the mother and neurobehavioral and co-regulatory challenges in the infant. Emotion dysregulation is an impairing, early-emerging, transdiagnostic vulnerability factor that has intergenerational implications. Treatments have been developed for non-pregnant adults with emotion dysregulation but these are costly, time-intensive, and do not address the unique needs of pregnant people, highlighting an unmet therapeutic need. Through this innovative intervention, researchers will test whether targeting emotion regulation skills use during pregnancy will both improve postpartum emotion regulation, newborn neurobehavior, and mother-infant co-regulation. Early identification of the mechanisms implicated in risk. The researchers will deliver 10 weeks of DBT skills classes selected and adapted to meet the unique needs of pregnancy (DBT-P). The goal of this work is to improve perinatal mental health trajectories.
The premise of this study-that improving emotion regulation in pregnancy may disrupt intergenerational transmission of psychopathology-is informed by our research over the past two decades, including several NIH awards (R01MH119070, R01MH132210, R01DA049755, R21MH1090777, F31MH074196). The investigator' data reveal that maternal emotion dysregulation confers risk for mother. The research also shows that resting respiratory sinus arrhythmia (RSA), a physiological index of emotion dysregulation, can be improved via intervention in non-pregnant adults. The investigators propose that DBT-P will increase emotion regulation skills use or increase RSA in the mother (target engagement) leading to significant reductions in her emotion dysregulation prior to birth.
The primary study objectives are to recruit 100 pregnant women with high emotion dysregulation to receive either: (1) dialectical behavior therapy skills groups or an Assessment only control; and (2) to evaluate whether the treatment improved emotion regulation skills use as well as respiratory sinus arrhythmia.
Вмешательства
- Поведенческое Moms2B
An established group-based pregnancy program focusing on improving nutrition, social, and medical support. - Поведенческое DBT-P
An emotional skills group where emotion regulation skills are taught in the context of the pregnancy and expected life with an infant.
Первичные конечные точки
- Difficulties in Emotion Regulation Scale (DERS) [Срок оценки: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)]
- Respiratory Sinus Arrhythmia (RSA) [Срок оценки: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)]
Вторичные конечные точки (10)
- Percent of participation [Срок оценки: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)]
- Percent of missing data [Срок оценки: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)]
- Recruitment rates [Срок оценки: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)]
- Reasons for refusal [Срок оценки: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)]
- Intervention adherence [Срок оценки: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)]
- Number of women who complete all sessions [Срок оценки: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)]
- Number of interventionists who can self-monitor for fidelity, assessed by watching segments of video-recorded sessions [Срок оценки: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)]
- Participation rates [Срок оценки: Post-treatment (Week 10)]
- Participant satisfaction with the intervention assessed by the Client Satisfaction Questionnaire [Срок оценки: Post-treatment (Week 10)]
- Telehealth acceptability specific to DBT skills training [Срок оценки: Post-treatment (Week 10)]
Критерии участия
Критерии включения
- Emotion dysregulation score of 88 or above
- At least 12 weeks pregnant
- Singleton Pregnancy
- Fluent in English
Критерии исключения
- Active psychosis
- Drug or alcohol use disorder during pregnancy
- High risk of an imminent suicide attempt
- Significant health complications (e.g., cancer)
- Illiterate and/or unable to independently complete and comprehend written measures
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Duke University — Durham
Идентификаторы
NCT: NCT06963801 · Pro00116252 · R61MH138444