Online Emotional Regulation Group Treatment
1 de octubre de 2015 actualizado por: Icahn School of Medicine at Mount Sinai
Online Emotional Regulation Group Treatment for Individuals With Traumatic Brain Injury (TBI)
This study will examine the feasibility of online delivery of emotional regulation training to individuals with TBI with emotional dysregulation.
80 subjects with significant emotional dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions twice a week for 12 weeks, delivered online in group modality.
Attendance and compliance will be tracked, and outcomes will be monitored using online data collection methods.
Treatment satisfaction and participant subjective experience will also be assessed.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
This study will examine the feasibility of online delivery of emotional regulation training to individuals with Traumatic Brain Injury who also have emotional dysregulation.
80 subjects with significant emotional dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions twice a week for 12 weeks, delivered online via a group meeting software.
Study participation will last 28 weeks: 4 weeks of baseline, 12 weeks of treatment (24 sessions) and 12 weeks of follow-up.
Assessments will be conducted at each of four timepoints: T1 (baseline), T2 (pre-treatment assessment), T3 (end-of-treatment assessment) and T4 (follow-up assessment).
In addition, a subset of the measures will be administered bi-weekly for the duration of the study.
Assessments will consist of a variety of measures designed to measure executive functioning, problem solving skills, and quality of life.
All assessments will be completed online, using a web-based data collection.
Attendance and treatment compliance will be tracked, and outcomes will be monitored using online data collection methods.
Treatment satisfaction and participant subjective experience (including technical difficulties that make access to web-delivered treatment impossible) will also be assessed.
Tipo de estudio
Intervencionista
Inscripción (Actual)
147
Fase
- Fase 1
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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New York
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New York, New York, Estados Unidos, 10029
- The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Documented TBI of any severity and being at least 6 months post injury
- Presence of executive dysfunction, manifested as self-reported difficulties with emotional and behavioral self-regulation, operationalized as endorsement of 25% or more of the symptoms on the Difficulties in Emotion Regulation Scale (DERS, Gratz & Roemer, 2004).
- Currently aged 18 or older
- English speaking
- At least low average intellectual functioning, operationalized as a minimum Verbal IQ score of 80 on the Wechsler Abbreviated Scale of Intelligence
- Ownership of and relative facility with use of a computer, webcam, and microphone
- Access to a broadband internet connection at sufficiently high speed to allow videoconference
Exclusion Criteria:
- DSM-IV-TR diagnosis of alcohol or substance abuse within past 6 months
- DSM-IV-TR of psychosis within past 6 months
- High suicidality, operationalized as a score of 17 or higher on the Mini International Neuropsychiatric Interview (M.I.N.I., Sheehan et al., 2008)
Participation in this study will not preclude participation in other treatments.
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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Online Emotional Regulation Treatment
Participants will receive 24 treatment sessions, with baseline, post-treatment screening and follow-up screening, and bi-weekly assessments
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Emotional Regulation Training (EmReg) is a cognitive-behavioral approach which aims to increase awareness, and self-monitoring of affective states to improve self-regulation.
EmReg combines didactic and experiential training, and emphasizes skill acquisition and generalization through examination of incidents of emotional dysregulation in one's life and completion of homework assignments.
The treatment is divided into two phases: knowledge provision and practice facilitation.
During the knowledge provision phase participants are introduced to the objectives and the main concepts of the treatment, to increase their familiarity with the terminology, and to the emotional regulation skills they acquire during the practice facilitation phase.
During the practice facilitation phase participants receive training in emotional regulation skills, which they practice in-session with the guidance of the therapist and feedback from the group, as well as out-of-session as homework assignments.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Difficulties in Emotion Regulation Scale(DERS)
Periodo de tiempo: up to 28 weeks
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36-item self-report questionnaire that focuses on emotional awareness, acceptance, ability to control impulsivity, and flexible use of strategies
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up to 28 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Brain Injury Rehabilitation Trust Regulation of Emotions Questionnaire (BREQ)
Periodo de tiempo: up to 28 weeks
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32 item self-report questionnaire assessing deficits in emotion regulation, developed specifically to assess emotional dysregulation related to TBI
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up to 28 weeks
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Problem Solving Inventory
Periodo de tiempo: up to 28 weeks
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35-item self-report questionnaire assessing problem solving capability
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up to 28 weeks
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Social Problem Solving Inventory-Revised: Short Form
Periodo de tiempo: up to 28 weeks
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25-item self-report questionnaire assessing problem solving in everyday living
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up to 28 weeks
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Positive Affect Negative Affect Scale
Periodo de tiempo: up to 28 weeks
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20-item self-report measure of positive and negative affect within a specified time frame
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up to 28 weeks
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Satisfaction with Life Scale
Periodo de tiempo: T1 (baseline)
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5- item measure of global satisfaction with life
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T1 (baseline)
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Satisfaction with Life Scale
Periodo de tiempo: T2 (week 4)
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5- item measure of global satisfaction with life
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T2 (week 4)
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Satisfaction with Life Scale
Periodo de tiempo: T3 (week 16)
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5- item measure of global satisfaction with life
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T3 (week 16)
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Satisfaction with Life Scale
Periodo de tiempo: T4 (week 28)
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5- item measure of global satisfaction with life
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T4 (week 28)
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Satisfaction with Therapy and Therapist Scale
Periodo de tiempo: T3 (week 16)
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12-item scale that assesses satisfaction with treatment and therapist
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T3 (week 16)
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Satisfaction with Therapy and Therapist Scale
Periodo de tiempo: T4 (week 28)
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12-item scale that assesses satisfaction with treatment and therapist
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T4 (week 28)
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Treatment Compliance
Periodo de tiempo: up to 28 weeks
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therapist's ratings of participant on each of the following areas at each session: attendance, participation, homework completion, skill acquisition, skill generalization, ease of use of technology, and interpersonal behavior
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up to 28 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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
1 de noviembre de 2012
Finalización primaria (Actual)
1 de octubre de 2015
Finalización del estudio (Actual)
1 de octubre de 2015
Fechas de registro del estudio
Enviado por primera vez
15 de noviembre de 2012
Primero enviado que cumplió con los criterios de control de calidad
15 de noviembre de 2012
Publicado por primera vez (Estimar)
21 de noviembre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
2 de octubre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
1 de octubre de 2015
Última verificación
1 de octubre de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GCO 12-1256-3
- HSM 12-00760
- IF1435434
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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