- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07707102
Advancing Skills Through Consultation, Education, and Novel Technologies (ASCENT)
Increasing the Reach of Evidence-Based PTSD Treatment: Development and Clinical Trial of Artificial Intelligence (AI)-Facilitated, Web-Based Written Exposure Therapy Training
This research study tests strategies to train behavioral health providers in Written Exposure Therapy (WET), an evidence-based treatment for posttraumatic stress disorder (PTSD). There are a number of evidence-based treatments for posttraumatic stress disorder (PTSD). However, most behavioral health providers have not received training in these PTSD treatments and do not offer them regularly to their patients.
The researchers hope to learn about the optimal way to train behavioral providers in this type of treatment. This study is designed to determine the comparative effectiveness of different training strategies on key outcomes such as how much competency providers develop in the therapy and to how many patients they deliver the therapy. This study will help the researchers understand if we can help more providers learn to competently delivery Written Exposure Therapy by using strategies that are more convenient and cost less money, including web-based and AI-facilitated training supports. This study will also help us learn which training strategies work best for which providers so that in the future we can make personalized training recommendations.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This study will enroll behavioral health providers (i.e., professional therapists) and test a training program for Written Exposure Therapy that includes
- an enhanced, web-based foundational training (web-based training plus integrated TherapyTrainer components) and
- an AI training support tool for competency development (TherapyTrainer).
This randomized clinical trial will compare web/AI training, among providers who serve Veterans and Service Members, to standard Written Exposure Therapy training (i.e., human-delivered live workshop and consultation calls) on provider, patient, and cost-effectiveness outcomes. There is no cross-over of conditions. Providers in both conditions will be eligible to earn continuing education credits and approval as Written Exposure Therapy Providers who have completed competency based training and two training cases.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Stefanie Losavio, PhD
- Número de teléfono: (210) 562-6714
- Correo electrónico: ASCENT@uthscsa.edu
Ubicaciones de estudio
-
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Texas
-
San Antonio, Texas, Estados Unidos, 78229
- Reclutamiento
- University of Texas Health Science Center at San Antonio
-
Contacto:
- Stefanie LoSavio, PhD
- Número de teléfono: 210-562-6714
- Correo electrónico: losavio@uthscsa.edu
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- mental health provider;
- serves veterans and/or service members with PTSD (by self-report);
- willing to participate in either live or web-based training.
Exclusion Criteria:
1. has already completed formal training in Written Exposure Therapy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Workshop + Consultation Calls
10-hour, live workshop over 2 days with a live trainer via video conferencing.
There will also be twelve 1 hour calls with a live therapy consultant .
|
Approximately 10 hours (excluding breaks) over 2 days with a live trainer via video conferencing (e.g., Zoom)
Twelve 1-hour calls with a live therapy consultant via videoconferencing (e.g., Zoom)
|
|
Comparador activo: Workshop + TherapyTrainer
10-hour, live workshop over 2 days with a live trainer via video conferencing.There will also be approximately 12 hours of engagement with the AI training support tool (TherapyTrainer)
|
Approximately 10 hours (excluding breaks) over 2 days with a live trainer via video conferencing (e.g., Zoom)
No live meetings, but approximately 12 hours of engaging with the AI training support tool (TherapyTrainer)
Otros nombres:
|
|
Comparador activo: Web-Based Training + Consultation Calls
AI enhanced Web-based training with no live meetings, but approximately 8-10 hours of asynchronous, self-paced training.
There will also be twelve 1 hour calls with a live therapy consultant .
|
Twelve 1-hour calls with a live therapy consultant via videoconferencing (e.g., Zoom)
No live meetings, but approximately 8-10 hours of asynchronous training at the learner's pace over about 1 month.
|
|
Comparador activo: Web-based Training + TherapyTrainer
AI enhanced Web-based training with no live meetings, but approximately 8-10 hours of asynchronous, self-paced training.
There will also be approximately 12 hours of engagement with the AI training support tool (TherapyTrainer)
|
No live meetings, but approximately 12 hours of engaging with the AI training support tool (TherapyTrainer)
Otros nombres:
No live meetings, but approximately 8-10 hours of asynchronous training at the learner's pace over about 1 month.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Provider WET Competency
Periodo de tiempo: Baseline to 7 months
|
A 20-item multiple choice treatment knowledge assessment.
Higher scores indicate greater knowledge of WET.
|
Baseline to 7 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Completion of Practice Cases
Periodo de tiempo: 4 months
|
Number of participants that complete practice cases
|
4 months
|
|
Time to complete Practice Cases
Periodo de tiempo: 4 months
|
Number of days to complete two training cases (real or simulated)
|
4 months
|
Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Stefanie LoSavio, PhD, The University of Texas Health Science Center at San Antonio
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00002482
- HT9425-25-1-0585 (Otro número de subvención/financiamiento: Department of Defense)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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