Clinical Trial to Evaluate the Efficacy of Building Emotional Self-awareness Teletherapy (BEST) at Improving Psychological Health in Service Members With Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 3
研究概览
简要总结
The purpose of the study is to test two different training programs to find out which is better at helping people with a concussion or mild TBI (mTBI) improve their emotional health and well-being. Study participation is completely remote and will last approximately 8 months total, involving 4 assessment visits and 8 sessions of brain training via a secure video-conferencing platform. The 4 assessment visits (about 30-90 minutes each) include surveys and questionnaires about participant's emotional health. These assessment visits will take place before the training, immediately after the training, 3 months after training and 6 months after training. The 8 sessions of 1-on-1 training (about 60-90 minutes each) will be completed over the course of approximately 1 month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •≥6 months post-TBI
- •Elevated alexithymia and emotion dysregulation
- •Capacity to consent
- •Speaks and understands English
- •Personal device capable of video conferencing and internet
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
- •Previous psychiatric hospitalization
- •Visual, hearing, communication, or cognitive impairments that would impede participation
- •Unstable medications (e.g., started < 6 weeks prior to enrollment) or anticipated medication changes that will influence mood/ affect during study participation
- •Active involvement in an intensive rehabilitation program
- •Individuals who recently started psychotherapy and/or mental health counseling (e.g., <3 months prior)
研究组 & 干预措施
Program 1
Enhance emotional awareness and ability to name, describe and express emotions with greater clarity, granularity and accuracy. Goals include enhancing participants' ability to: recognize and embrace the benefits of emotional awareness; detect onset of emotional responses early before escalation; accurately label and differentiate emotions; discern emotions from non-emotions; recognize and experience a larger breadth of emotions, including pleasant emotions.
干预措施: Program 1 (Behavioral)