Emotional Awareness Therapy Study (TREAT)
A Feasibility Study Exploring Emotional Health Training After Moderate to Severe Traumatic Brain Injury
The purpose of this study is to learn about the potential benefits of two different training programs in helping improve emotional health and well-being in people who have had a traumatic brain injury.
Participants will be assigned to one of two programs based on the time since their injury. One of the programs will teach participants how to recognize and label emotions; the other will teach healthy ways of living. Participants may improve their emotional well-being and contribute to the knowledge needed to achieve better emotional health outcomes for people with TBI.
For eligible participants, the study includes 4 assessments. Assessments may take 30-60 minutes and will be done using secure videoconferencing, phone calls, and/or electronic surveys. The first assessment will ask questions about demographics, the participant's brain injury, and some medical history. All assessments will include questions about emotions, emotional awareness, resilience, loneliness, and how participants manage emotions, in addition to broader wellness questions and questions about how participants interact with others.
Regardless of the program, the training includes 8 one-on-one sessions with a trained staff member over the course of about 1 month. Each session will last approximately 60-90 minutes. These sessions will start shortly after completing the first assessment. Preferably, participants will complete 1-2 training sessions a week, depending on availability and preference. These sessions will include education, discussion, and practice exercises.
After the program is finished, participants will be asked to complete the same surveys completed at baseline for three follow-up time points (immediately following the program, 3 months after the program, and 6 months after). Total participation in the study will last approximately 8 months.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Grace Wells, BS
- Número de teléfono: 68682 732-321-7000
- Correo electrónico: grace.wells1@hmhn.org
Ubicaciones de estudio
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New Jersey
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Edison, New Jersey, Estados Unidos, 08820
- Reclutamiento
- Hackensack Meridian Health - JFK Johnson Rehabilitation Institute
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Investigador principal:
- Dawn Neumann, PhD, FACRM
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Contacto:
- Grace Wells, BS
- Número de teléfono: 68682 732-321-7000
- Correo electrónico: grace.wells1@hmhn.org
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Contacto:
- Sarah Enock, BS
- Número de teléfono: 848-893-6577
- Correo electrónico: tbiresearchjfkjri@hmhn.org
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Moderate or Severe TBI
- ≥18 years old
- ≥6 months post-TBI
- Speaks and understands English
- Medications that can influence mood should be stable (6+ weeks)
- Elevated alexithymia
- Demonstrate an understanding of the study and their rights (e.g. ability to answer the following questions correctly after a review of the study details during pre-screening process)
Exclusion Criteria:
- Premorbid neurological disorder other than TBI
- Degenerative neurologic condition
- Active or uncontrolled major psychiatric disorder
- Conditions that pose safety concern to self or others, such as suicide risk
- Visual, hearing, communication, or cognitive impairments that would impede participation
- Active involvement in an intensive rehabilitation program
- Individuals who recently started psychotherapy and/or mental health counseling
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: TREAT-A
Eight lessons delivered by a trained team member (interventionist) to the participant over ~4 weeks.
It involves psycho-educational lessons and skill-building exercises to achieve the following objectives based on the characteristics of alexithymia.: 1) learn benefits of emotional awareness; 2) improve threshold for earlier detection of emotional responses; 3) label and differentiate emotions; 4) experience range of emotions; and 5) distinguish emotions from thoughts, actions and sensations.
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The TREAT-A program will teach participants how to recognize, label, and differentiate their emotions.
The program will cover ways to reduce feeling "confused" or numb, and decrease the feelings of anger, stress and being overwhelmed.
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Comparador activo: TREAT-B
Provides education on TBI and overall brain health through instructional sessions, discussion, and structured tasks geared towards living healthy and improving general well-being.
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The TREAT-B program will teach participants strategies to improve their overall brain health and functioning.
It will also teach participants how to develop and work towards individualized short-term and long-term goals aimed at improving their quality of life.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Ineligibility and Attrition Rates
Periodo de tiempo: Through study completion, an average of 8 months
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Data will be tracked on the number of individuals who were ineligible (and reasons for ineligibility) as well as withdrawals (reasons for withdrawal) and /or number of participants who become "lost" (no longer able to contact).
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Through study completion, an average of 8 months
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Satisfaction Survey and Interview
Periodo de tiempo: immediate post-treatment
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Range: Min/ Max = 1 to 5 Lower scores are worse; higher scores are more satisfied
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immediate post-treatment
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Interventionist Evaluation of Session Participation
Periodo de tiempo: intervention training sessions 1-8 (approximately 8 months)
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Range: Min/Max = 6 to 24 Internal assessment completed by the interventionist at the end of each training session.
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intervention training sessions 1-8 (approximately 8 months)
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Patient Global Impression of Change (PGIC) emotional functioning and quality of life
Periodo de tiempo: immediate post-treatment
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Range: Min/ Max = 1 to 7 Lower scores are worse; higher scores are better.
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immediate post-treatment
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Care-partner Global Impression of Change (CGIC) emotional functioning and quality of life
Periodo de tiempo: immediate post-treatment
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Range: Min/ Max = 1 to 7 Lower scores are worse; higher scores are better.
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immediate post-treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Toronto Alexithymia Scale-20
Periodo de tiempo: 1) baseline 2) immediate post-treatment, 3) 3 months post-treatment; 4) 6- months post-treatment.
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Range: Min/ Max = 20 to 100 Lower scores indicate less alexithymia (good); higher scores indicate greater alexithymia (bad)
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1) baseline 2) immediate post-treatment, 3) 3 months post-treatment; 4) 6- months post-treatment.
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Difficulty with Emotion Regulation Scale (DERS; Co-Primary outcome)
Periodo de tiempo: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
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Range: Min/ Max = 36 to 180 Lower scores indicate less dysregulation (good); higher scores indicate more dysregulation (bad)
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1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
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Brief Resilience Scale
Periodo de tiempo: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
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Range: Min/ Max = 6 to 30 Lower scores indicate worse resilience; higher scores indicate better resilience
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1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Dawn Neumann, PhD, FACRM, Hackensack Meridian Health
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
- Pro2026-0081
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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