Идёт набор NCT05933629

Community-based Implementation of Online EmReg

Без фазы С лечением Traumatic Brain Injury Emotion Regulation

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: Online EmReg, Consultation Sessions.
Кому может быть актуально: Состояния в реестре: Traumatic Brain Injury, Emotion Regulation. Базовые параметры: от 18 лет · Все.
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

Community-based Implementation of an Emotion Regulation Intervention for Individuals With Traumatic Brain Injury

Обзор

This is a hybrid type III implementation-effectiveness trial; this study design blends elements of implementation and clinical effectiveness research, with the primary aim of determining the utility of an implementation strategy and a secondary aim of assessing clinical outcomes associated with the implementation trial. Consistent with best practices for this type of design, the study team will conduct a randomized test of the effect of implementation strategy on effective delivery of the Online EmReg intervention in clinical practice. Specifically, the study team will compare Standard Training (a 3-hour on-demand training workshop) to Extended Training, (a 3-hour on-demand training workshop with 3 months of bi-weekly consultation). The research team's primary aim is to determine the optimal strategy to train clinicians in effectively delivering Online EmReg, and secondary aim is to assess patient improvement per clinician-administered DERS. Outcome measures will be assessed via self-report surveys, performance evaluations (via role-plays), and tracked clinician participation and fidelity. Study participation is expected to last up to 18 months.

Вмешательства

Поведенческое Online EmReg
A Web-based group intervention to improve emotion regulation in individuals with traumatic brain injury (TBI). Online EmReg is a 3-hour on-demand training workshop
Поведенческое Consultation Sessions
3 months of bi-weekly consultation sessions

Первичные конечные точки

Provider Self-Efficacy Scale Score [Срок оценки: Up to 18 months]
Performance Evaluation (via Role Plays) [Срок оценки: Post-3 hour EmReg training workshop]

Вторичные конечные точки (9)

Training Satisfaction Rating Scale [Срок оценки: Up to 18 months]
Acceptability of Intervention Measure (AIM) [Срок оценки: Up to 18 months]
Feasibility of Intervention Measure (FIM) Scale [Срок оценки: Up to 18 months]
Intervention Appropriateness Measure (IAM) Scale [Срок оценки: Up to 18 months]
Number of EmReg groups scheduled and completed [Срок оценки: Up to 18 months]
Time between initial uptake and completion [Срок оценки: Up to 18 months]
Skills Acquisition Quiz for Providers (SAQ-P) [Срок оценки: Up to 18 months]
Number of participants who receive treatment [Срок оценки: Up to 18 months]
Difficulties in Emotion Regulation Scale (DERS) [Срок оценки: Up to 18 months]

Критерии участия

Критерии включения

Licensed psychologist, social worker, or mental health counselor.
Training and experience in CBT, the framework for EmReg.
Experience working with people with TBI.
Experience providing group treatment.
A computer and internet to conduct group treatment via telehealth.
Actively treating ≥3 patients with TBI who are appropriate for EmReg (have emotion regulation difficulties based on clinician assessment).
Amenable to study tasks (e.g., completion of training, consultation, performance based role-play, data collection).
Not previously trained in EmReg.
Proficient in English.