- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02954146
Mobile Health Application for Family and Behavioral Health Provider Communication
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Purpose: we will examine feasibility, tolerability, utilization, and effectiveness of using the SupportTeam mobile application in the context of Cognitive Behavioral Therapy (CBT) for veterans with PTSD.
Participants: (N=100) 50 veterans who have served in the military since October 2001 and have PTSD with anger problems; and 50 collateral family members/close friends above the age of 18.
Procedures (methods): All Veterans with PTSD will receive a 12 session standard CBT for anger. Veterans in the intervention group will additionally receive instructions for using SupportTeam with a family member or friend that will provide data for the CBT clinician. Veterans in the control group will receive the CBT sessions, but will not receive the SupportTeam mobile application.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Durham, North Carolina, Estados Unidos, 27705
- Duke University, Department of Psychiatry
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
For Veteran:
- Age 18 or older
- Served in a branch of the US military since October, 2001
- Meets DSM-5 criteria for current PTSD as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5);
- Reports at least one episode of anger or irritability in the past week;
- Has and regularly uses an iOS (iPhone 5s or higher with iOS 8 or higher) or Android (with 4G network and Android 4.1 or higher) smartphone with a data plan;
- Has a family member or friend who also has and uses a smartphone with a data plan and agrees to participate in the study.
- Is able and willing to attend 12 weekly sessions at Duke Psychiatry offices within normal business hours (M-F 8:00-5:00)
For Collateral:
- 18 years old or older
- Has and regularly uses an iOS (iPhone 5s or higher with iOS 8 or higher) or Android (with 4G network and Android 4.1 or higher) smartphone with a data plan;
- Has a family member or friend who meets the veteran inclusion criteria and agrees to participate in the study.
Exclusion Criteria, Veteran:
- Is currently participating in, or is scheduled to participate in a manualized psychosocial treatment.
Plan de estudios
¿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 |
---|---|
Comparador activo: CBT only
Veterans will receive 12 weekly individual cognitive behavioral therapy (CBT only) sessions for anger management.
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Connectd is a mobile application that collects and automatically analyzes input from patients with PTSD/TBI, as well as their families, for clinician review.
The app will aggregate patient and family input on current issues, relationship stressors, and situational stressors to better focus (personalize) treatment as well as to more efficiently and accurately understand key factors and root causes.
In addition, the app provides informational resources for veterans and family regarding treatment options and mental health supports.
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Experimental: CBT + Connectd mobile health app
Veterans will receive 12 weekly individual cognitive behavioral therapy (CBT) sessions for anger management.
In addition, veterans in this group will also receive instructions for using Connectd mobile health app with a family member or friend that will provide data for the CBT clinician.
|
Connectd is a mobile application that collects and automatically analyzes input from patients with PTSD/TBI, as well as their families, for clinician review.
The app will aggregate patient and family input on current issues, relationship stressors, and situational stressors to better focus (personalize) treatment as well as to more efficiently and accurately understand key factors and root causes.
In addition, the app provides informational resources for veterans and family regarding treatment options and mental health supports.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Working Alliance Inventory (Short Form, Therapist)
Periodo de tiempo: 12 weeks
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Documents perspectives of therapist-client relationship
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12 weeks
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Participant Treatment Participation
Periodo de tiempo: 12 weeks
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Number of weekly sessions attended by participants
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12 weeks
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Working Alliance Inventory (Client)
Periodo de tiempo: 12 weeks
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Documents perspectives of therapist-client relationship
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12 weeks
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PTSD Knowledge Scale
Periodo de tiempo: 12 weeks
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Measures general knowledge about PTSD
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12 weeks
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Zarit Burden Interview
Periodo de tiempo: 12 weeks
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Measures stress felt by caregivers
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12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Dimensions of Anger Reactions
Periodo de tiempo: 12 weeks
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Measure of anger disposition towards others
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12 weeks
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Clinician-Administered PTSD Scale for DSM5 (CAPS 5)
Periodo de tiempo: Past month
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Assessment of PTSD symptoms
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Past month
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Eric Elbogen, PhD, Duke
- Silla de estudio: Greg Barish, PhD, InferLink Corporation
- Silla de estudio: Patricia E Lester, MD, University of California, Los Angeles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
- Pro00069014
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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