Online Emotional Regulation Group Treatment for Individuals With Traumatic Brain Injury (TBI)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 2
- 主要终点
- Difficulties in Emotion Regulation Scale(DERS)
研究概览
简要总结
This study will examine the feasibility of online delivery of emotional regulation training to individuals with TBI with emotional dysregulation. 80 subjects with significant emotional dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions twice a week for 12 weeks, delivered online in group modality. Attendance and compliance will be tracked, and outcomes will be monitored using online data collection methods. Treatment satisfaction and participant subjective experience will also be assessed.
详细描述
This study will examine the feasibility of online delivery of emotional regulation training to individuals with Traumatic Brain Injury who also have emotional dysregulation. 80 subjects with significant emotional dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions twice a week for 12 weeks, delivered online via a group meeting software. Study participation will last 28 weeks: 4 weeks of baseline, 12 weeks of treatment (24 sessions) and 12 weeks of follow-up. Assessments will be conducted at each of four timepoints: T1 (baseline), T2 (pre-treatment assessment), T3 (end-of-treatment assessment) and T4 (follow-up assessment). In addition, a subset of the measures will be administered bi-weekly for the duration of the study. Assessments will consist of a variety of measures designed to measure executive functioning, problem solving skills, and quality of life. All assessments will be completed online, using a web-based data collection. Attendance and treatment compliance will be tracked, and outcomes will be monitored using online data collection methods. Treatment satisfaction and participant subjective experience (including technical difficulties that make access to web-delivered treatment impossible) will also be assessed.
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
- •Documented TBI of any severity and being at least 6 months post injury
- •Presence of executive dysfunction, manifested as self-reported difficulties with emotional and behavioral self-regulation, operationalized as endorsement of 25% or more of the symptoms on the Difficulties in Emotion Regulation Scale (DERS, Gratz & Roemer, 2004).
- •Currently aged 18 or older
- •English speaking
- •At least low average intellectual functioning, operationalized as a minimum Verbal IQ score of 80 on the Wechsler Abbreviated Scale of Intelligence
- •Ownership of and relative facility with use of a computer, webcam, and microphone
- •Access to a broadband internet connection at sufficiently high speed to allow videoconference
排除标准
- •DSM-IV-TR diagnosis of alcohol or substance abuse within past 6 months
- •DSM-IV-TR of psychosis within past 6 months
- •High suicidality, operationalized as a score of 17 or higher on the Mini International Neuropsychiatric Interview (M.I.N.I., Sheehan et al., 2008)
- •Participation in this study will not preclude participation in other treatments.
结局指标
主要结局
Difficulties in Emotion Regulation Scale(DERS)
时间窗: up to 28 weeks
36-item self-report questionnaire that focuses on emotional awareness, acceptance, ability to control impulsivity, and flexible use of strategies
次要结局
- Social Problem Solving Inventory-Revised: Short Form(up to 28 weeks)
- The Brain Injury Rehabilitation Trust Regulation of Emotions Questionnaire (BREQ)(up to 28 weeks)
- Satisfaction with Life Scale(T4 (week 28))
- Satisfaction with Therapy and Therapist Scale(T4 (week 28))
- Positive Affect Negative Affect Scale(up to 28 weeks)
- Problem Solving Inventory(up to 28 weeks)
- Treatment Compliance(up to 28 weeks)