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临床试验/NCT07624825
NCT07624825招募中不适用

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

Hackensack Meridian Health1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2026年6月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

TREAT-B

Active Comparator

Provides education on TBI and overall brain health through instructional sessions, discussion, and structured tasks geared towards living healthy and improving general well-being.

干预措施: TREAT-B (Behavioral)

TREAT-A

Experimental

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.

干预措施: TREAT-A (Behavioral)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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