Training to Reconnect With Emotional Awareness Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in Levels of Emotional Awareness Scale (LEAS)
研究概览
简要总结
To decrease emotional self-awareness deficits and improve emotional self-regulation, particularly anxiety, anger, depression, and positive affect, through the treatment of alexithymia.
详细描述
Phase II randomized, Waitlist Control (WLC) trial with 3-month follow-up to further establish proof of concept and early efficacy of TREAT (1:1 alexithymia treatment) for post-TBI alexithymia. It is anticipated that our target sample size is 44. The purpose of this study is to examine differences in post-treatment self-reported alexithymia and emotional self-awareness in participants with TBI randomized to TREAT or WLC. In addition to examining the differences in post-treatment self-reported emotion regulation (general), anxiety, anger, depression, positive affect (PA), global emotional function and quality of life in participants with TBI randomized to TREAT or WLC.
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
- Single (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
- •TBI (injury due to a external physical force)
- •Complicated mild, moderate, or severe TBI (defined by Glasgow Coma Scale (GCS) in Emergency Department (ED) (≤12), or Post traumatic amnesia (PTA) (≥1 day),Loss of Conscientious (LOC) (≥30 minutes),or positive head CT scan consistent with TBI)
- •At least 18 years or older
- •≥1 year post-injury
- •Adequate vision, hearing, speech, and comprehension
- •Reliable mode of transportation
- •Available for treatment during regular business hours
- •Have moderate to high screening alexithymia score (TAS-20 ≥52)
- •If participating in active psychological treatment prior to enrollment, their participation must be ongoing for 4 or more weeks
排除标准
- •Diagnosed with pre-morbid neurological disorder that could affect mood and cognition (e.g., stroke, Alzheimer's disease, Parkinson's disease); does not include controlled seizures
- •Diagnosed with major psychiatric disorder (e.g., schizophrenia, Borderline Personality Disorder)
- •Severe Depression and/or perceived risk to self or others
- •Developmental disability (e.g. autism, developmental delay)
- •Unstable or anticipated medication changes related to mood or emotion during study participation
- •Having started psychological treatment less than 4 weeks prior to enrollment
- •Actively participating in the Traumatic Brain Injury Model System (TBIMS) alexithymia outcome module
结局指标
主要结局
Change in Levels of Emotional Awareness Scale (LEAS)
时间窗: Baseline Week , 6, 18, 30
objective, performance-based measure of emotional awareness and labeling. Short hypothetical scenarios are presented and participants are asked to describe how they and others would feel in the context of the scenarios. Participants' responses are scored with an electronic system, removing human bias and interpretation. The LEAS has parallel forms (A and B), which will alternate at testing sessions.
Change in Toronto Alexithymia Scale-20 (TAS-20)
时间窗: Baseline Week , 6, 18, 30
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 alexithymia). Subscales are summed to compute a total score. Scores between 52 and 60 indicate moderate alexithymia; scores 61 and higher indicate high alexithymia.
次要结局
- Difficulty with Emotion Regulation Scale (DERS)(Baseline Week , 6, 18, 30)
- Patient Health Questionnaire 9 (PHQ-9)(Baseline Week , 6, 18, 30)
- Caregiver Global Impression of Change (CaGIC)(Week 6, 18, 30)
- Positive and Negative Affect Scale (PANAS)(Baseline Week , 6, 18, 30)
- Patient Global Impression of Change (PGIC)(Week 6 or 18 depending on randomization)
- Generalized Anxiety Disorder Assessment (GAD-7):(Baseline Week , 6, 18, 30)
- State-Trait Anger Expression Inventory (STAXI)(Baseline Week , 6, 18, 30)
- Participant Satisfaction(Week 6 or 18 depending on randomization)
研究者
Flora Hammond
Chair of Department of Physical Medicine and Rehabilitation
Indiana University