Building Emotional Self-Awareness Teletherapy (BEST): a Tool to Optimize Psychological Health Outcomes for Persons with Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Toronto Alexithymia Scale-20 (TAS-20)
研究概览
简要总结
To examine the feasibility, acceptability, and preliminary efficacy of a remotely delivered intervention for civilians and service members with mild traumatic brain injury (mTBI) who have difficulty recognizing and regulating their emotions. Post-treatment outcomes of interest include emotional self-awareness and regulation, resiliency, and affective symptoms.
详细描述
This Phase I proof of principle pilot study of the Building Emotional Self-awareness Teletherapy (BEST) intervention will use a quasi-experimental, non-randomized, one-group pretest-posttest design with a double pretest and a 3-month follow-up in approximately 40 participants with mTBI (~20 civilians and ~20 service members). Study objectives are to explore the feasibility and early efficacy of BEST to improve psychological health outcomes in civilian and Service Member (SM) participants with mTBI who have alexithymia (poor emotional self-awareness) and emotion dysregulation. We anticipate BEST will have good feasibility and acceptability in both civilian and service member participants, and post-treatment assessments will show significant improvements in alexithymia, emotion regulation, resiliency, and affective symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Mild TBI (determined by Ohio State University TBI Identification Method)
- •≥18 years old
- •U.S. resident (exclusion for California residents)
- •≥6 months post-TBI
- •elevated alexithymia and emotion dysregulation (defined by >.5 standard deviation above means on the TAS-20 and DERS)
- •capacity to consent
- •proficient English
- •if on medications that influence affect, must be stable for at least 6 weeks
- •access to a device capable of video conferencing and high speed internet.
排除标准
- •Premorbid neurological disorder other than TBI (e.g., stroke), active or uncontrolled major psychiatric disorder and/ or disorder that would pose a safety concern (e.g., borderline personality disorder)
- •degenerative neurologic condition
- •visual, hearing, communication, or cognitive impairments that would impede participation
- •unstable or anticipated medication changes that will influence mood/ affect during study participation
- •active involvement in an intensive rehabilitation program
- •individuals who recently started psychotherapy (e.g., < 3 months ago)
- •participant behaviors that cause concern for their ability to participate in accordance with the study requirements and protocol (e.g., unreliable correspondences, no-shows, no-replies to multiple contacts, habitual rescheduling, unable to complete study requirements in timely manner)
- •concurrent participation in any other clinical trial that aims to improve mood/ behavioral functioning will be an exclusion criterion.
- •participants will be excluded if at any point, they participated in TREAT (in-person clinical trial of BEST - NCT03414463)
结局指标
主要结局
Change in Toronto Alexithymia Scale-20 (TAS-20)
时间窗: Baseline, Week 6, Week 12, Week 24
This is a 20-item self report questionnaire comprised of three sub-constructs (Difficulty Identifying feelings, Difficulty Describing feelings, Externally-oriented Thinking). The full scale range is 20-100 (higher scores indicate higher (worse) alexithymia). Subscales are summed to compute a total score.
次要结局
- Change in Levels of Emotional Awareness Scale (LEAS)(Baseline, Week 6, Week 12, Week 24)
- Change in Difficulty with Emotion Regulation Scale (DERS)(Baseline, Week 6, Week 12, Week 24)
研究者
Flora Hammond
Chair of Department of Physical Medicine and Rehabilitation
Indiana University