Trauma Survivors Outcomes and Support Study IV (TSOS IV)
17 de noviembre de 2017 actualizado por: Douglas Zatzick, University of Washington
Integrating Information Technology Advancements Into Early PTSD Interventions
After traumatic injuries some people have difficulty returning to the routine of their everyday activities and may experience physical and emotional pain. The purpose of this study is to identify new ways of providing support for physically injured trauma survivors. All study procedures are designed to work around patient needs and be as flexible as possible in order to best fit into patients' post-injury recovery.
Patients who are eligible for the study are randomly assigned to receive care as usual, or the "new method of treatment," with the study Trauma Support Specialist (TSS). This TSS will be in contact with the patient for the next three months; they may visit the patient at the hospital or at outpatient medical appointments. The TSS will also be available to talk with the patient over the telephone. Overall, the TSS will be working with the patient to help with difficulties returning to his or her routine and overcoming physical and emotional pain experienced after the injury. We believe that patients who receive the "new method of treatment," will be more able to return to daily routines and/or cope with the emotional stress that can occur after an injury. Intervention technology innovations including mHealth applications and web-based links will be included in the investigation.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Clinical feasibility randomized clinical trial (RCT) pilot of integrating information technology advancements into Early PTSD Screening and Intervention.
Design Overview: Between 30-200 injured trauma survivors who are initially admitted to either the Harborview inpatient wards or emergency department acute care settings will be enrolled in the study.
If patients agree to participate, they will be engaged by a research assistant to complete a baseline assessment battery.
Following the battery, all patients will be engaged in an initial technology readiness assessment to gauge comfort and skill using a variety of devices (e.g., smartphones, cellular phones, tablets, and laptop computers) that could potentially be utilized for delivery of interventions.
Patients will then be randomized to either care as usual or to the stepped-care technology-based educational intervention.
Patients randomized to the intervention condition will be met by a trauma support specialist.
Intervention patients who endorse elevated substance use and/or mental health symptoms, including PTSD, depression, suicidal ideation, chronic pain, and postconcussive symptoms, will receive up to 3 months of motivational interviewing and/or cognitive behavioral therapy delivered by the trauma support specialist in person or over the telephone.
The trauma support specialist may utilize mHealth technologies including websites and applications available on smartphones and tablet devices, as strategies to compliment CBT approaches that target specific areas of concern.
However, the psychotherapeutic intervention embedded within the Stepped Care protocol is conceived of being fundamentally separate from the mHealth tools that may also be mentioned during discussions between the trauma support specialist and the patient.
Inherent throughout the intervention is a focus on obtaining acceptability information from patients related to all aspects of the intervention and interpersonal experiences with the trauma support specialist, as well as any technology-based assessments and mHealth tools that may compliment the stepped care protocol.
Patients will receive up to 3 consecutive months of trauma support specialist support post-injury.
Follow-up assessments will occur at 1, 3, and 6 months following the baseline assessment, with additional acceptability assessments completed for specific aspects of the intervention listed above.
Tipo de estudio
Intervencionista
Inscripción (Actual)
121
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Washington
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Seattle, Washington, Estados Unidos, 98104
- Harborview Medical Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
14 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Score ≥3 on PTSD automated screening algorithm
- Score ≥35 on PTSD checklist (PCL-C)
Exclusion Criteria:
- Non-English speaking
- Under 14 years of age
- Patients in need of acute psychiatric intervention (e.g., suicide attempt, psychosis)
- Suffered head, spinal cord, or other sever injuries that prevent participation in the inpatient ward interview.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Stepped Care Management
All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns.
The TSS will complete follow-up correspondence across the 3-6 month time period to assess mental health functioning and use of information technology that addresses medical concerns.
Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-6 months.
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All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns.
The TSS will complete follow-up correspondence across the 3-6 month time period to assess mental health functioning and use of information technology that addresses medical concerns.
Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-6 months.
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Sin intervención: Usual Care
Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cambio en los síntomas de depresión en el transcurso de los seis meses posteriores a la lesión
Periodo de tiempo: Los investigadores evaluaron al inicio, 1, 3 y 6 meses.
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Los investigadores utilizaron el Cuestionario de salud del paciente (PHQ-9) como medida continua, con puntuaciones que oscilaban entre 1 y 27.
Las puntuaciones más altas representan un peor resultado.
No se utilizaron subescalas.
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Los investigadores evaluaron al inicio, 1, 3 y 6 meses.
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Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury
Periodo de tiempo: The investigators assessed at baseline, 1-, 3-, and 6-month.
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The investigators used the PTSD Checklist - Civilian (PCL-C) as a continuous measure.
The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome.
No subscales were used.
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The investigators assessed at baseline, 1-, 3-, and 6-month.
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Technology Use
Periodo de tiempo: Baseline to 6 months
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The investigators used laptop tracking software to determine technology usage.
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Baseline to 6 months
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Feasibility/Acceptability of Intervention
Periodo de tiempo: Baseline to 6 months
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The investigators used laptop tracking software to assess number of patients using laptops.
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Baseline to 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Problemas de consumo de alcohol
Periodo de tiempo: Los investigadores evaluaron al inicio, 1, 3 y 6 meses.
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Los investigadores utilizaron la prueba de identificación de trastornos por consumo de alcohol (AUDIT) como medida continua.
La puntuación de la escala de 10 elementos varía de 0 a 40, y los valores más altos indican un peor resultado.
No se utilizaron subescalas.
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Los investigadores evaluaron al inicio, 1, 3 y 6 meses.
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Physical Functioning
Periodo de tiempo: The investigators assessed at baseline, 1-, 3-, and 6-month.
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The investigators used the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function.
The minimum and maximum scores are 0-100 with higher scores representing a better outcome.
No other subscales will be used.
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The investigators assessed at baseline, 1-, 3-, and 6-month.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Douglas Zatzick, M.D., University of Washington
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Zatzick D, O'Connor SS, Russo J, Wang J, Bush N, Love J, Peterson R, Ingraham L, Darnell D, Whiteside L, Van Eaton E. Technology-Enhanced Stepped Collaborative Care Targeting Posttraumatic Stress Disorder and Comorbidity After Injury: A Randomized Controlled Trial. J Trauma Stress. 2015 Oct;28(5):391-400. doi: 10.1002/jts.22041.
- Kelly CM, Van Eaton EG, Russo JE, Kelly VC, Jurkovich GJ, Darnell DA, Whiteside LK, Wang J, Parker LE, Payne TH, Mooney SD, Bush N, Zatzick DF. Technology Use, Preferences, and Capacity in Injured Patients at Risk for Posttraumatic Stress Disorder. Psychiatry. 2017 Fall;80(3):279-285. doi: 10.1080/00332747.2016.1271162.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de julio de 2012
Finalización primaria (Actual)
1 de agosto de 2013
Finalización del estudio (Actual)
1 de octubre de 2015
Fechas de registro del estudio
Enviado por primera vez
19 de junio de 2012
Primero enviado que cumplió con los criterios de control de calidad
20 de junio de 2012
Publicado por primera vez (Estimar)
21 de junio de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de diciembre de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
17 de noviembre de 2017
Última verificación
1 de noviembre de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Síntomas de comportamiento
- Desordenes mentales
- Comportamiento de bebida
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Heridas y Lesiones
- Trauma craneoencefálico
- Trauma, Sistema Nervioso
- Trastornos relacionados con el trauma y el estrés
- Comportamiento auto agresivo
- Consumo de alcohol
- Depresión
- Lesiones Cerebrales
- Trastornos de Estrés, Traumáticos
- Trastornos de estrés postraumático
- Lesiones Cerebrales Traumáticas
- Suicidio
Otros números de identificación del estudio
- STUDY00001473
- 1R01AA016102-01 (Subvención/contrato del NIH de EE. UU.)
- 1K24MH086814-01 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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