Emotional Awareness Therapy Study

Официальное название

A Feasibility Study Exploring Emotional Health Training After Moderate to Severe Traumatic Brain Injury

Обзор

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.

Вмешательства

• Поведенческое TREAT-A
  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.
• Поведенческое TREAT-B
  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.

Первичные конечные точки

• Ineligibility and Attrition Rates [Срок оценки: Through study completion, an average of 8 months]
• Satisfaction Survey and Interview [Срок оценки: immediate post-treatment]
• Interventionist Evaluation of Session Participation [Срок оценки: intervention training sessions 1-8 (approximately 8 months)]
• Patient Global Impression of Change (PGIC) emotional functioning and quality of life [Срок оценки: immediate post-treatment]
• Care-partner Global Impression of Change (CGIC) emotional functioning and quality of life [Срок оценки: immediate post-treatment]

Вторичные конечные точки (3)

• Toronto Alexithymia Scale-20 [Срок оценки: 1) baseline 2) immediate post-treatment, 3) 3 months post-treatment; 4) 6- months post-treatment.]
• Difficulty with Emotion Regulation Scale (DERS; Co-Primary outcome) [Срок оценки: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months]
• Brief Resilience Scale [Срок оценки: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Hackensack Meridian Health - JFK Johnson Rehabilitation Institute — Edison

Идентификаторы

NCT: NCT07624825 · Pro2026-0081

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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